82 results on '"Murphy, Helen R."'
Search Results
2. Technology advances in diabetes pregnancy: right technology, right person, right time
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McLean, Anna, Maple-Brown, Louise, and Murphy, Helen R.
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- 2024
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3. Metabolomic insights into maternal and neonatal complications in pregnancies affected by type 1 diabetes
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Meek, Claire L., Stewart, Zoe A., Feig, Denice S., Furse, Samuel, Neoh, Sandra L., Koulman, Albert, and Murphy, Helen R.
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- 2023
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4. MAGIC (maternal glucose in pregnancy) understanding the glycemic profile of pregnancy, intensive CGM glucose profiling and its relationship to fetal growth: an observational study protocol
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Scott, Eleanor M, Murphy, Helen R., Myers, Jenny, Saravanan, Ponnusamy, Poston, Lucilla, and Law, Graham R
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- 2023
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5. Healthcare professionals' views about how pregnant women can benefit from using a closed-loop system: Qualitative study
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Lawton, Julia, Rankin, David, Hartnell, Sara, Lee, Tara, Dover, Anna R, Reynolds, Rebecca M, Hovorka, Roman, Murphy, Helen R, Hart, Ruth I, AiDAPT Collaborative Group, Lawton, Julia [0000-0002-8016-7374], Rankin, David [0000-0002-5835-3402], Reynolds, Rebecca M [0000-0001-6226-8270], Hovorka, Roman [0000-0003-2901-461X], Murphy, Helen R [0000-0001-6876-8727], Hart, Ruth I [0000-0003-2129-9163], and Apollo - University of Cambridge Repository
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Blood Glucose ,type 1 diabetes ,Blood Glucose Self-Monitoring ,healthcare professionals ,Diabetes Mellitus, Type 1 ,Insulin Infusion Systems ,Pregnancy ,technology ,Humans ,continuous glucose monitoring ,Female ,Pregnant Women ,closed-loop system ,Delivery of Health Care ,qualitative research - Abstract
Funder: Efficacy and Mechanism Evaluation (EME) Programme; Id: http://dx.doi.org/10.13039/501100001922, Funder: National Institute for Health Research Cambridge Biomedical Research Centre; Id: http://dx.doi.org/10.13039/501100018956, Funder: Juvenile Diabetes Research Foundation International; Id: http://dx.doi.org/10.13039/100000901, BACKGROUND: Interest is growing in how closed-loop systems can support attainment of within-target glucose levels amongst pregnant women with type 1 diabetes. We explored healthcare professionals' views about how, and why, pregnant women benefitted from using the CamAPS FX system during the AiDAPT trial. METHODS: We interviewed 19 healthcare professionals who supported women using closed-loop during the trial. Our analysis focused on identifying descriptive and analytical themes relevant to clinical practice. RESULTS: Healthcare professionals highlighted clinical and quality-of-life benefits to using closed-loop in pregnancy; albeit, they attributed some of these to the continuous glucose monitoring component. They emphasised that the closed-loop was not a panacea and that, to gain maximum benefit, an effective collaboration between themselves, the woman and the closed-loop was needed. Optimal performance of the technology, as they further noted, also required women to interact with the system sufficiently, but not excessively; a requirement that they felt some women had found challenging. Even where healthcare professionals felt that this balance was not achieved, they suggested that women had still benefitted from using the system. Healthcare professionals reported difficulties predicting how specific women would engage with the technology. In light of their trial experiences, healthcare professionals favoured an inclusive approach to closed-loop rollout in routine clinical care. CONCLUSIONS: Healthcare professionals recommended that closed-loop systems be offered to all pregnant women with type 1 diabetes in the future. Presenting closed-loop systems to pregnant women and healthcare teams as one pillar of a three-party collaboration may help promote optimal use.
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- 2023
6. Continuous glucose monitoring targets in type 1 diabetes pregnancy: every 5% time in range matters
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Murphy, Helen R.
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- 2019
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7. Community-based pre-pregnancy care programme improves pregnancy preparation in women with pregestational diabetes
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Yamamoto, Jennifer M., Hughes, Deborah J. F., Evans, Mark L., Karunakaran, Vithian, Clark, John D. A., Morrish, Nicholas J., Rayman, Gerry A., Winocour, Peter H., Hambling, Clare, Harries, Amanda W., Sampson, Michael J., and Murphy, Helen R.
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- 2018
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8. AiDAPT: automated insulin delivery amongst pregnant women with type 1 diabetes: a multicentre randomized controlled trial - study protocol
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Lee, Tara TM, Collett, Corinne, Man, Mei-See, Hammond, Matt, Shepstone, Lee, Hartnell, Sara, Gurnell, Eleanor, Byrne, Caroline, Scott, Eleanor M, Lindsay, Robert S, Morris, Damian, Brackenridge, Anna, Dover, Anna R, Reynolds, Rebecca M, Hunt, Katharine F, McCance, David R, Barnard-Kelly, Katharine, Rankin, David, Lawton, Julia, Bocchino, Laura E, Sibayan, Judy, Kollman, Craig, Wilinska, Malgorzata E, Hovorka, Roman, Murphy, Helen R, AiDAPT Collaborative Group, Murphy, Helen R [0000-0002-5489-0614], Apollo - University of Cambridge Repository, Ayman, G, and Group, AiDAPT Collaborative
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Blood Glucose ,Blood Glucose Self-Monitoring ,Diabetes Mellitus, Type 1/drug therapy ,Infant, Newborn ,Obstetrics and Gynecology ,Hypoglycemic Agents/therapeutic use ,Blood Glucose/analysis ,Study Protocol ,Diabetes Mellitus, Type 1 ,Insulin Infusion Systems ,Pregnancy ,Insulin/therapeutic use ,Humans ,Hypoglycemic Agents ,Insulin ,Multicenter Studies as Topic ,Female ,Pregnant Women ,Randomized Controlled Trials as Topic - Abstract
Background Pregnant women with type 1 diabetes strive for tight glucose targets (3.5-7.8 mmol/L) to minimise the risks of obstetric and neonatal complications. Despite using diabetes technologies including continuous glucose monitoring (CGM), insulin pumps and contemporary insulin analogues, most women struggle to achieve and maintain the recommended pregnancy glucose targets. This study aims to evaluate whether the use of automated closed-loop insulin delivery improves antenatal glucose levels in pregnant women with type 1 diabetes. Methods/design A multicentre, open label, randomized, controlled trial of pregnant women with type 1 diabetes and a HbA1c of ≥48 mmol/mol (6.5%) at pregnancy confirmation and ≤ 86 mmol/mol (10%) at randomization. Participants who provide written informed consent before 13 weeks 6 days gestation will be entered into a run-in phase to collect 96 h (24 h overnight) of CGM glucose values. Eligible participants will be randomized on a 1:1 basis to CGM (Dexcom G6) with usual insulin delivery (control) or closed-loop (intervention). The closed-loop system includes a model predictive control algorithm (CamAPS FX application), hosted on an android smartphone that communicates wirelessly with the insulin pump (Dana Diabecare RS) and CGM transmitter. Research visits and device training will be provided virtually or face-to-face in conjunction with 4-weekly antenatal clinic visits where possible. Randomization will stratify for clinic site. One hundred twenty-four participants will be recruited. This takes into account 10% attrition and 10% who experience miscarriage or pregnancy loss. Analyses will be performed according to intention to treat. The primary analysis will evaluate the change in the time spent in the target glucose range (3.5-7.8 mmol/l) between the intervention and control group from 16 weeks gestation until delivery. Secondary outcomes include overnight time in target, time above target (> 7.8 mmol/l), standard CGM metrics, HbA1c and psychosocial functioning and health economic measures. Safety outcomes include the number and severity of ketoacidosis, severe hypoglycaemia and adverse device events. Discussion This will be the largest randomized controlled trial to evaluate the impact of closed-loop insulin delivery during type 1 diabetes pregnancy. Trial registration ISRCTN 56898625 Registration Date: 10 April, 2018.
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- 2022
9. Interventions to enhance pre‐pregnancy care for women with type 2 diabetes: A systematic review of the literature.
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Hopkins, Lily, Forbes, Angus, Anderson, Janet E., Bick, Debra, Brackenridge, Anna, Banerjee, Anita, Chamley, Mark, Chua, Kia‐Chong, Flynn, Angela C., Hunt, Katherine, Murphy, Helen R., Rogers, Helen, White, Sara L., Winkley, Kirsty, and Forde, Rita
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ONLINE information services ,MEDICAL databases ,PREGNANCY ,MEDICAL information storage & retrieval systems ,SYSTEMATIC reviews ,WOMEN ,TYPE 2 diabetes ,TREATMENT effectiveness ,MEDLINE ,LONGITUDINAL method - Abstract
Aims: The aim of the study was to examine the content and impact of interventions that have been used to increase the uptake of pre‐pregnancy care for women with type 2 diabetes, and their impact on maternal and fetal outcomes. Methods: A systematic search of multiple databases was conducted in November 2021, and updated July 2022, to identify studies assessing interventions to enhance pre‐pregnancy care for women with type 2 diabetes. Over 10% of articles were screened by two reviewers at title and abstract phase, after which all selected full‐text articles were screened by two reviewers. Quality assessment was conducted using the Critical Appraisal Skills Programme checklist for cohort studies. Meta‐analysis was not possible due to study heterogeneity; therefore, narrative synthesis was conducted. Results: Four eligible cohort studies were identified. The conclusions able to be drawn by this review were limited as women with type 2 diabetes (n = 800) were in the minority in all four studies (35%–40%) and none of the interventions were exclusively tailored for them. The uptake of pre‐pregnancy care was lower in women with type 2 diabetes (8%–10%) compared with other participant groups in the studies. Pregnancy preparation indicators generally improved among all groups exposed to pre‐pregnancy care, with varying impact on pregnancy outcomes. Conclusions: This review demonstrates that previous interventions have had a limited impact on pre‐pregnancy care uptake in women with type 2 diabetes. Future studies should focus on tailored interventions for improving pre‐pregnancy care for women with type 2 diabetes, particularly those from ethnic minorities and living in poorer communities. [ABSTRACT FROM AUTHOR]
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- 2023
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10. Improved pregnancy outcomes in women with type 1 and type 2 diabetes but substantial clinic-to-clinic variations: a prospective nationwide study
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Murphy, Helen R., Bell, Ruth, Cartwright, Cher, Curnow, Paula, Maresh, Michael, Morgan, Margery, Sylvester, Catherine, Young, Bob, and Lewis-Barned, Nick
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- 2017
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11. Impaired awareness of hypoglycaemia in women with type 1 diabetes in pregnancy: Hypoglycaemia fear, glycaemic and pregnancy outcomes
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Bahrami, Jasmine, Tomlinson, George, Murphy, Helen R, Feig, Denice S, CONCEPTT Collaborative Group, Murphy, Helen R [0000-0001-6876-8727], Feig, Denice S [0000-0001-8561-7584], and Apollo - University of Cambridge Repository
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diabetes mellitus type 1 ,Blood Glucose ,endocrine system diseases ,pregnancy complications ,pregnancy in diabetes ,pregnancy outcomes ,Blood Glucose Self-Monitoring ,Infant, Newborn ,Pregnancy Outcome ,nutritional and metabolic diseases ,Fear ,severe hypoglycaemia ,Hypoglycemia ,Diabetes Mellitus, Type 1 ,Pregnancy ,diabetes mellitus ,Humans ,Female ,hormones, hormone substitutes, and hormone antagonists ,hypoglycaemia - Abstract
Funder: Juvenile Diabetes Research Foundation International; Id: http://dx.doi.org/10.13039/100000901, Funder: Juvenile Diabetes Research Foundation Canada; Id: http://dx.doi.org/10.13039/100009881, AIMS: To examine maternal fear of hypoglycaemia, glycaemia and pregnancy outcomes in women with impaired and normal awareness of hypoglycaemia. METHODS: A pre-planned sub-study of 214 pregnant women with type 1 diabetes who participated in the CONCEPTT trial. Participants completed hypoglycaemia fear surveys (HFS-II) at baseline. Logistic regression and Poisson regression analyses were used to obtain an adjusted estimate for the rate ratio relating awareness to the number of severe hypoglycaemic episodes, and for several neonatal outcomes in relation to the total HFS-II score. The role of continuous glucose monitoring (CGM) use was examined. RESULTS: Overall, 30% of participants reported impaired awareness of hypoglycaemia (n = 64). Women with impaired awareness of hypoglycaemia had more episodes of severe hypoglycaemia (mean 0.44 vs. 0.08, p < 0.001) (12-34 weeks gestation) and scored higher on the HFS-II scale (43.7 vs. 36.0, p 0.008), indicating more fear of hypoglycaemia. They spent more time below range (CGM
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- 2022
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12. Technology and Pregnancy.
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Yamamoto, Jennifer M. and Murphy, Helen R.
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HYPERGLYCEMIA , *FETAL macrosomia , *PRECONCEPTION care , *PREGNANCY , *HIGH-risk pregnancy , *MISCARRIAGE , *PREGNANCY outcomes , *MEDICAL personnel - Abstract
This year's diabetes pregnancy manuscripts, three for each of type 1 diabetes (T1D), type 2 diabetes (T2D), and gestational diabetes mellitus (GDM), were chosen from over 3500 published articles. Data were collected on pregnant women with diabetes (any type) with DKA events (cases) and pregnant women with diabetes without DKA (controls) from 194 maternity units between April 2019 and September 2020. Another concerning finding is the prevalence of diabetic ketoacidosis (DKA) during pregnancy in all types of diabetes. Seventy DKA events (85%) occurred in women with T1D (incidence 16.6/100,000; 95% CI, 13.0-20.9), 5 DKA events (6%) in women with T2D (incidence 1.1/100,000; 95% CI, 0.4-2.5), and 7 (9%) in women diagnosed with GDM. [Extracted from the article]
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- 2023
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13. Diagnosis of gestational diabetes mellitus: falling through the net
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Meek, Claire L., Lewis, Hannah B., Patient, Charlotte, Murphy, Helen R., and Simmons, David
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- 2015
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14. Novel Biochemical Markers of Glycemia to Predict Pregnancy Outcomes in Women With Type 1 Diabetes
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Meek, Claire L, Tundidor, Diana, Feig, Denice S, Yamamoto, Jennifer M, Scott, Eleanor M, Ma, Diane D, Halperin, Jose A, Murphy, Helen R, Corcoy, Rosa, CONCEPTT Collaborative Group, Meek, Claire L [0000-0002-4176-8329], Scott, Eleanor M [0000-0001-5395-8261], Murphy, Helen R [0000-0001-6876-8727], Corcoy, Rosa [0000-0001-5055-6814], and Apollo - University of Cambridge Repository
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Blood Glucose ,Glycated Hemoglobin ,Diabetes Mellitus, Type 1 ,endocrine system diseases ,Pregnancy ,Blood Glucose Self-Monitoring ,Infant, Newborn ,Pregnancy Outcome ,Humans ,nutritional and metabolic diseases ,Female ,Biomarkers - Abstract
Objective: The optimal method of monitoring glycemia in pregnant women with type 1 diabetes remains controversial. This study aimed to assess the predictive performance of HbA1c, continuous glucose monitoring (CGM) metrics, and alternative biochemical markers of glycemia to predict obstetric and neonatal outcomes. Methods: 157 women from the CGM in pregnant women with type 1 diabetes trial (CONCEPTT) were included in this pre-specified secondary analysis. HbA1c, CGM data, and alternative biochemical markers (glycated CD59, 1,5 anhydroglucitol, fructosamine and glycated albumin) were compared at approximately 12, 24 and 34 weeks gestation using logistic regression and ROC curves to predict pregnancy complications (pre-eclampsia, preterm delivery, large-for-gestational-age, neonatal hypoglycemia, admission to neonatal intensive care unit). Results: HbA1c, CGM metrics, and alternative laboratory markers were all significantly associated with obstetric and neonatal outcomes at 24 weeks gestation. More outcomes were associated with CGM metrics during the 1st trimester and with laboratory markers (area under ROC generally 140 mg/dl; >7.8 mmol/l) were the most consistently predictive CGM metrics. HbA1c was also a consistent predictor of suboptimal pregnancy outcomes. Some alternative laboratory markers showed promise, but overall, they had lower predictive ability than HbA1c. Conclusions: HbA1c is still an important biomarker for obstetric and neonatal outcomes in type 1 diabetes pregnancy. Alternative biochemical markers of glycemia and other CGM metrics did not substantially increase the prediction of pregnancy outcomes compared to widely available HbA1c and increasingly available CGM metrics (TIR and TAR).
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- 2021
15. Continuous Glucose Monitoring Time-in-Range and HbA1c Targets in Pregnant Women with Type 1 Diabetes
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Tundidor, Diana, Meek, Claire L, Yamamoto, Jennifer, Martínez-Bru, Cecilia, Gich, Ignasi, Feig, Denice S, Murphy, Helen R, Corcoy, Rosa, CONCEPTT Collaborative Group, Tundidor, Diana [0000-0002-8629-9706], Meek, Claire L [0000-0002-4176-8329], Corcoy, Rosa [0000-0001-5055-6814], and Apollo - University of Cambridge Repository
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Blood Glucose ,Glycated Hemoglobin ,endocrine system diseases ,Blood Glucose Self-Monitoring ,Infant, Newborn ,Pregnancy Outcome ,nutritional and metabolic diseases ,Time-in-range ,HbA1c target ,Type 1 diabetes ,Diabetes Mellitus, Type 1 ,Pregnancy ,Humans ,Premature Birth ,Female ,Pregnant Women ,Continuous glucose monitoring - Abstract
The CONCEPTT trial compared real-time Continuous Glucose Monitoring (RT-CGM) to capillary glucose monitoring in pregnant women with type 1 diabetes. We analyzed CGM and glycated hemoglobin (HbA1c) measures in first (n = 221), second (n = 197), and third (n = 172) trimesters, aiming to examine target glucose attainment and associations with pregnancy outcomes. CGM targets were Time-in-range (TIR) > 70%, Time-above-range (TAR)
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- 2021
16. Likelihood of ‘falling through the net’ relates to contemporary prevalence of gestational diabetes. Reply to Ikomi A, Mannan S, Anthony R, Kiss S [letter]
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Meek, Claire L., Lewis, Hannah B., Patient, Charlotte, Murphy, Helen R., and Simmons, David
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- 2015
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17. Effectiveness of continuous glucose monitoring in pregnant women with diabetes: randomised clinical trial
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Murphy, Helen R, Rayman, Gerry, Lewis, Karen, Kelly, Susan, Johal, Balroop, Duffield, Katherine, Fowler, Duncan, Campbell, Peter J, and Temple, Rosemary C
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- 2008
18. What's new in the management of type 1 diabetes in pregnancy?
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Lee, Tara TM and Murphy, Helen R
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Type 1 diabetes in pregnancy is associated with an increased risk of complications for both mother and fetus. However, managing glycaemia during pregnancy to reduce these risks is challenging, owing to changes in insulin resistance with advancing gestation, as well as increased daily variation in insulin pharmacokinetics. These factors can add significant psychological and daily self-care burden to mothers during what may already be an anxious time. Increasingly, diabetes technologies are being used during pregnancy to improve and facilitate diabetes self-care. While these can be empowering for people with type 1 diabetes, careful consideration is required in relation to how and when these can be continued safely in the inpatient setting (including acute antenatal admissions, labour and delivery) and when extra support is required from adequately trained healthcare professionals. This article describes current forms of diabetes technologies used and the latest national guidance relating to the care of type 1 diabetes in pregnancy. [ABSTRACT FROM AUTHOR]
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- 2022
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19. Clinical Update on Gestational Diabetes Mellitus.
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Sweeting, Arianne, Wong, Jencia, Murphy, Helen R, and Ross, Glynis P
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GESTATIONAL diabetes ,PREGNANCY ,EPIDEMIOLOGY - Abstract
Gestational diabetes mellitus (GDM) traditionally refers to abnormal glucose tolerance with onset or first recognition during pregnancy. GDM has long been associated with obstetric and neonatal complications primarily relating to higher infant birthweight and is increasingly recognized as a risk factor for future maternal and offspring cardiometabolic disease. The prevalence of GDM continues to rise internationally due to epidemiological factors including the increase in background rates of obesity in women of reproductive age and rising maternal age and the implementation of the revised International Association of the Diabetes and Pregnancy Study Groups' criteria and diagnostic procedures for GDM. The current lack of international consensus for the diagnosis of GDM reflects its complex historical evolution and pragmatic antenatal resource considerations given GDM is now 1 of the most common complications of pregnancy. Regardless, the contemporary clinical approach to GDM should be informed not only by its short-term complications but also by its longer term prognosis. Recent data demonstrate the effect of early in utero exposure to maternal hyperglycemia, with evidence for fetal overgrowth present prior to the traditional diagnosis of GDM from 24 weeks' gestation, as well as the durable adverse impact of maternal hyperglycemia on child and adolescent metabolism. The major contribution of GDM to the global epidemic of intergenerational cardiometabolic disease highlights the importance of identifying GDM as an early risk factor for type 2 diabetes and cardiovascular disease, broadening the prevailing clinical approach to address longer term maternal and offspring complications following a diagnosis of GDM. [ABSTRACT FROM AUTHOR]
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- 2022
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20. The Challenges and Future Considerations Regarding Pregnancy-Related Outcomes in Women with Pre-Existing Diabetes
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Singh, Harsimran, Murphy, Helen R., Hendrieckx, Christel, Ritterband, Lee, and Speight, Jane
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- 2013
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21. Reappearance of C-Peptide During the Third Trimester of Pregnancy in Type 1 Diabetes: Pancreatic Regeneration or Fetal Hyperinsulinism?
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Meek, Claire L, Oram, Richard A, McDonald, Timothy J, Feig, Denice S, Hattersley, Andrew T, Murphy, Helen R, CONCEPTT Collaborative Group, Meek, Claire L [0000-0002-4176-8329], and Apollo - University of Cambridge Repository
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Blood Glucose ,Diabetes Mellitus, Type 1 ,C-Peptide ,Pregnancy ,Blood Glucose Self-Monitoring ,Hyperinsulinism ,Pregnancy Trimester, Third ,Pregnancy Outcome ,Humans ,Regeneration ,Female - Abstract
Objective: We assessed longitudinal patterns of maternal C-peptide concentration to examine the hypothesis of beta-cell regeneration in type 1 diabetes pregnancy. Research Design & Methods: C-peptide was measured on maternal serum samples from 127 participants (12, 24, 34 weeks) and cord blood during the continuous glucose monitoring in type 1 diabetes pregnancy trial (CONCEPTT). C-peptide was measured using a highly sensitive direct and solid-phase competitive electrochemiluminescent immunoassay. Results: Three discrete patterns of maternal C-peptide trajectory were identified: Pattern 1 undetectable throughout pregnancy, n=74 (58%, maternal C-peptide Conclusion: First maternal C-peptide appearance at 34 weeks was associated with mid-trimester hyperglycemia, elevated cord blood C-peptide and high rates of neonatal complications. This suggests transfer of C-peptide from fetal to maternal serum and is inconsistent with pregnancy-related beta-cell regeneration.
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- 2021
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22. Which growth standards should be used to identify large- and small-for-gestational age infants of mothers with type 1 diabetes? A pre-specified analysis of the CONCEPTT trial
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Meek, Claire L., Corcoy, Rosa, Asztalos, Elizabeth, Kusinski, Laura C., López, Esther, Feig, Denice S., Murphy, Helen R., Asztalos, Elisabeth, Barrett, Jon F. R., De Leiva, Alberto, Donovan, Lois E., Hod, J. Moshe, Jovanovic, Lois, Keely, Erin, Kollman, Craig, McManus, Ruth, Murphy, Kellie E., Ruedy, Katrina, Tomlinson, George, Meek, Claire L. [0000-0002-4176-8329], and Apollo - University of Cambridge Repository
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CONCEPTT ,Pregnancy ,Diabetes ,Birth-weight ,Growth standards ,INTERGROWTH ,Maternal health and pregnancy ,Large-for-gestational-age ,Small for gestational age ,Macrosomia ,Research Article ,GROW - Abstract
Background: Offspring of women with type 1 diabetes are at increased risk of fetal growth patterns which are associated with perinatal morbidity. Our aim was to compare rates of large- and small-for-gestational age (LGA; SGA) defined according to different criteria, using data from the Continuous Glucose Monitoring in Type 1 Diabetes Pregnancy Trial (CONCEPTT). Methods: This was a pre-specified analysis of CONCEPTT involving 225 pregnant women and liveborn infants from 31 international centres (ClinicalTrials.gov NCT01788527; registered 11/2/2013). Infants were weighed immediately at birth and GROW, INTERGROWTH and WHO centiles were calculated. Relative risk ratios, sensitivity and specificity were used to assess the different growth standards with respect to perinatal outcomes, including neonatal hypoglycaemia, hyperbilirubinaemia, respiratory distress, neonatal intensive care unit (NICU) admission and a composite neonatal outcome. Results: Accelerated fetal growth was common, with mean birthweight percentiles of 82.1, 85.7 and 63.9 and LGA rates of 62, 67 and 30% using GROW, INTERGROWTH and WHO standards respectively. Corresponding rates of SGA were 2.2, 1.3 and 8.9% respectively. LGA defined according to GROW centiles showed stronger associations with preterm delivery, neonatal hypoglycaemia, hyperbilirubinaemia and NICU admission. Infants born > 97.7th centile were at highest risk of complications. SGA defined according to INTERGROWTH centiles showed slightly stronger associations with perinatal outcomes. Conclusions: GROW and INTERGROWTH standards performed similarly and identified similar numbers of neonates with LGA and SGA. GROW-defined LGA and INTERGROWTH-defined SGA had slightly stronger associations with neonatal complications. WHO standards underestimated size in preterm infants and are less applicable for use in type 1 diabetes. Trial registration: This trial is registered with ClinicalTrials.gov. number NCT01788527. Trial registered 11/2/2013.
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- 2021
23. Role of Continuous Glucose Monitoring in the Management of Diabetic Pregnancy
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Hewapathirana, Niranjala M., O’Sullivan, Esther, and Murphy, Helen R.
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- 2013
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24. Technology and Pregnancy.
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Yamamoto, Jennifer M. and Murphy, Helen R.
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PRENATAL depression , *HYPERGLYCEMIA , *PREGNANCY , *GESTATIONAL diabetes , *TYPE 1 diabetes , *PREGNANCY complications , *MEDICAL sciences - Abstract
Similarly, in late pregnancy, women with type 2 diabetes were more likely to have anxiety symptoms (31 vs 11%; I P i =0.002) and depressive symptoms (23 vs 4%; I P i =0.002) compared to women without diabetes. Compared to women without diabetes, those with type 2 diabetes were more likely to have both anxiety symptoms (36 vs 6%; I P i <0.001) and depressive symptoms (14 vs 2%; I P i =0.003) in early pregnancy. Conclusions While mean sensor glucose over 24 h and overnight were similar between IS-CGM and RT-CGM, time below range overnight was higher when assessed using IS-CGM compared to masked RT-CGM in early pregnancy. The manuscripts chosen for this yearbook address key controversies in the screening and detection of gestational diabetes mellitus (GDM), glycemic metrics using intermittent and continuous glucose monitoring (CGM) in type 1 diabetes and the theory of beta-cell regeneration. [Extracted from the article]
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- 2022
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25. Day-and-Night Closed-Loop Insulin Delivery in a Broad Population of Pregnant Women With Type 1 Diabetes: A Randomized Controlled Crossover Trial
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Stewart, Zoe A, Wilinska, Malgorzata E, Hartnell, Sara, O'Neil, Leanne K, Rayman, Gerry, Scott, Eleanor M, Barnard, Katharine, Farrington, Conor, Hovorka, Roman, Murphy, Helen R, Rayman, Gerry [0000-0003-3331-7015], Murphy, Helen R [0000-0001-6876-8727], and Apollo - University of Cambridge Repository
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Adult ,Blood Glucose ,Cross-Over Studies ,Time Factors ,Adolescent ,Postpartum Period ,Pregnancy Outcome ,Pregnancy in Diabetics ,Middle Aged ,Delivery, Obstetric ,Hypoglycemia ,Circadian Rhythm ,Young Adult ,Diabetes Mellitus, Type 1 ,Insulin Infusion Systems ,Treatment Outcome ,Pregnancy ,Hyperinsulinism ,Humans ,Hypoglycemic Agents ,Insulin ,Female - Abstract
OBJECTIVE: Despite advances in technology, optimal glucose control remains elusive and neonatal complications remain ubiquitous in type 1 diabetes (T1D) pregnancy. Our aim was to examine the safety, efficacy, and longer-term feasibility of day-and-night closed-loop insulin delivery. RESEARCH DESIGN AND METHODS: We recruited 16 pregnant women (mean [SD]: age 32.8 [5.0] years, T1D duration 19.4 [10.2] years, HbA1c 8.0% [1.1], and BMI 26.6 [4.4] kg/m2) to an open-label, randomized, crossover trial. Participants completed 28 days of closed-loop and sensor-augmented pump (SAP) insulin delivery separated by a washout period. Afterward, participants could continue to use the closed-loop system up to 6 weeks postpartum. The primary end point was the proportion of time with glucose levels within the target range (63-140 mg/dL). RESULTS: The proportion of time with glucose levels within target was comparable during closed-loop and SAP insulin delivery (62.3 vs. 60.1% [95% CI -4.1 to 8.3]; P = 0.47). Mean glucose and time spent hyperglycemic >140 mg/dL also did not differ (131.4 vs. 131.4 mg/dL [P = 0.85] and 36.6 vs. 36.1% [P = 0.86], respectively). During closed-loop, fewer hypoglycemic episodes occurred (median 8 [range 1-17] vs. 12.5 [1-53] over 28 days; P = 0.04) and less time at
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- 2018
26. Continuous glucose monitoring in pregnant women with type 1 diabetes (CONCEPTT): a multicentre international randomised controlled trial
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Feig, Denice S, Donovan, Lois E, Corcoy, Rosa, Murphy, Kellie E, Amiel, Stephanie A, Hunt, Katharine F, Asztalos, Elizabeth, Barrett, Jon FR, Sanchez, J Johanna, de Leiva, Alberto, Hod, Moshe, Jovanovic, Lois, Keely, Erin, McManus, Ruth, Hutton, Eileen K, Meek, Claire L, Stewart, Zoe A, Wysocki, Tim, O'Brien, Robert, Ruedy, Katrina, Kollman, Craig, Tomlinson, George, Murphy, Helen R, CONCEPTT Collaborative Group, Meek, Claire [0000-0002-4176-8329], and Apollo - University of Cambridge Repository
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Adult ,Blood Glucose ,Observer Variation ,Internationality ,endocrine system diseases ,Adolescent ,Pregnancy Outcome ,Risk Assessment ,Severity of Illness Index ,Young Adult ,Diabetes Mellitus, Type 1 ,Pregnancy ,Odds Ratio ,Humans ,Insulin ,Female ,Monitoring, Physiologic - Abstract
BACKGROUND: Pregnant women with type 1 diabetes are a high-risk population who are recommended to strive for optimal glucose control, but neonatal outcomes attributed to maternal hyperglycaemia remain suboptimal. Our aim was to examine the effectiveness of continuous glucose monitoring (CGM) on maternal glucose control and obstetric and neonatal health outcomes. METHODS: In this multicentre, open-label, randomised controlled trial, we recruited women aged 18-40 years with type 1 diabetes for a minimum of 12 months who were receiving intensive insulin therapy. Participants were pregnant (≤13 weeks and 6 days' gestation) or planning pregnancy from 31 hospitals in Canada, England, Scotland, Spain, Italy, Ireland, and the USA. We ran two trials in parallel for pregnant participants and for participants planning pregnancy. In both trials, participants were randomly assigned to either CGM in addition to capillary glucose monitoring or capillary glucose monitoring alone. Randomisation was stratified by insulin delivery (pump or injections) and baseline glycated haemoglobin (HbA1c). The primary outcome was change in HbA1c from randomisation to 34 weeks' gestation in pregnant women and to 24 weeks or conception in women planning pregnancy, and was assessed in all randomised participants with baseline assessments. Secondary outcomes included obstetric and neonatal health outcomes, assessed with all available data without imputation. This trial is registered with ClinicalTrials.gov, number NCT01788527. FINDINGS: Between March 25, 2013, and March 22, 2016, we randomly assigned 325 women (215 pregnant, 110 planning pregnancy) to capillary glucose monitoring with CGM (108 pregnant and 53 planning pregnancy) or without (107 pregnant and 57 planning pregnancy). We found a small difference in HbA1c in pregnant women using CGM (mean difference -0·19%; 95% CI -0·34 to -0·03; p=0·0207). Pregnant CGM users spent more time in target (68% vs 61%; p=0·0034) and less time hyperglycaemic (27% vs 32%; p=0·0279) than did pregnant control participants, with comparable severe hypoglycaemia episodes (18 CGM and 21 control) and time spent hypoglycaemic (3% vs 4%; p=0·10). Neonatal health outcomes were significantly improved, with lower incidence of large for gestational age (odds ratio 0·51, 95% CI 0·28 to 0·90; p=0·0210), fewer neonatal intensive care admissions lasting more than 24 h (0·48; 0·26 to 0·86; p=0·0157), fewer incidences of neonatal hypoglycaemia (0·45; 0·22 to 0·89; p=0·0250), and 1-day shorter length of hospital stay (p=0·0091). We found no apparent benefit of CGM in women planning pregnancy. Adverse events occurred in 51 (48%) of CGM participants and 43 (40%) of control participants in the pregnancy trial, and in 12 (27%) of CGM participants and 21 (37%) of control participants in the planning pregnancy trial. Serious adverse events occurred in 13 (6%) participants in the pregnancy trial (eight [7%] CGM, five [5%] control) and in three (3%) participants in the planning pregnancy trial (two [4%] CGM and one [2%] control). The most common adverse events were skin reactions occurring in 49 (48%) of 103 CGM participants and eight (8%) of 104 control participants during pregnancy and in 23 (44%) of 52 CGM participants and five (9%) of 57 control participants in the planning pregnancy trial. The most common serious adverse events were gastrointestinal (nausea and vomiting in four participants during pregnancy and three participants planning pregnancy). INTERPRETATION: Use of CGM during pregnancy in patients with type 1 diabetes is associated with improved neonatal outcomes, which are likely to be attributed to reduced exposure to maternal hyperglycaemia. CGM should be offered to all pregnant women with type 1 diabetes using intensive insulin therapy. This study is the first to indicate potential for improvements in non-glycaemic health outcomes from CGM use. FUNDING: Juvenile Diabetes Research Foundation, Canadian Clinical Trials Network, and National Institute for Health Research.
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- 2019
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27. The top 10 research priorities in diabetes and pregnancy according to women, support networks and healthcare professionals.
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Ayman, Göher, Strachan, James A., McLennan, Niamh, Malouf, Reem, Lowe‐Zinola, Jack, Magdi, Fida, Roberts, Nia, Alderdice, Fiona, Berneantu, Iuliana, Breslin, Niki, Byrne, Caroline, Carnell, Sonya, Churchill, David, Grisoni, Jeannie, Hirst, Jane E., Morris, Anna, Murphy, Helen R., O'Brien, Jane, Schmutz, Caroline, and Shah, Kamini
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WELL-being ,MATERNAL health services ,RESEARCH evaluation ,ATTITUDES of mothers ,PRIORITY (Philosophy) ,ATTITUDE (Psychology) ,PREGNANT women ,MEDICAL personnel ,DIET ,SURVEYS ,SUPPORT groups ,HEALTH behavior ,GESTATIONAL diabetes ,ROUTINE diagnostic tests ,POSTNATAL care ,PRENATAL care ,MEDICAL research ,DISEASE management ,BEHAVIOR modification - Abstract
Aims: To undertake a Priority Setting Partnership (PSP) to establish priorities for future research in diabetes and pregnancy, according to women with experience of pregnancy, and planning pregnancy, with any type of diabetes, their support networks and healthcare professionals. Methods: The PSP used established James Lind Alliance (JLA) methodology working with women and their support networks and healthcare professionals UK‐wide. Unanswered questions about the time before, during or after pregnancy with any type of diabetes were identified using an online survey and broad‐level literature search. A second survey identified a shortlist of questions for final prioritisation at an online consensus development workshop. Results: There were 466 responses (32% healthcare professionals) to the initial survey, with 1161 questions, which were aggregated into 60 unanswered questions. There were 614 responses (20% healthcare professionals) to the second survey and 18 questions shortlisted for ranking at the workshop. The top 10 questions were: diabetes technology, the best test for diabetes during pregnancy, diet and lifestyle interventions for diabetes management during pregnancy, emotional and well‐being needs of women with diabetes pre‐ to post‐pregnancy, safe full‐term birth, post‐natal care and support needs of women, diagnosis and management late in pregnancy, prevention of other types of diabetes in women with gestational diabetes, women's labour and birth experiences and choices and improving planning pregnancy. Conclusions: These research priorities provide guidance for research funders and researchers to target research in diabetes and pregnancy that will achieve greatest value and impact. [ABSTRACT FROM AUTHOR]
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- 2021
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28. Can placental growth factors explain birthweight variation in offspring of women with type 1 diabetes?
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Bacon, Siobhan, Burger, Dylan, Tailor, Mayur, Sanchez, J. Johanna, Tomlinson, George, Murphy, Helen R., and Feig, Denice S.
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Aims/hypothesis: Maternal hyperglycaemia alone does not explain the incidence of large offspring amongst women with type 1 diabetes. The objective of the study was to determine if there is an association between placental function, as measured by angiogenic factors, and offspring birthweight z score in women with type 1 diabetes. Methods: This cohort study included samples from 157 Continuous Glucose Monitoring in Pregnant Women with Type 1 Diabetes (CONCEPTT) trial participants. Correlations were estimated between birthweight z score and placental growth factor (PlGF) and soluble fms-like tyrosine kinase (sFlt-1) levels measured at baseline and at 24 and 34 weeks of gestation. Linear regression was used to assess the relationship between birthweight z score and placental health, as measured by PlGF and sFlt-1/PlGF ratio, stratified by glycaemic status (continuous glucose monitoring and HbA
1c measures) and adjusted for potential confounders of maternal BMI, smoking and weight gain. Higher PlGF levels and lower sFlt-1/PlGF ratios represent healthy placentas, while lower PlGF levels and higher sFlt-1/PlGF ratios represent unhealthy placentas. Results: Among CONCEPTT participants, the slopes relating PlGF levels to birthweight z scores differed according to maternal glycaemia at 34 weeks of gestation (p = 0.003). With optimal maternal glycaemia (HbA1c < 48 mmol/mol [6.5%]/ or continuous glucose monitoring time above range ≤ 30%), birthweight z scores were reduced towards zero (normal weight) with increasing PlGF values (representing a healthy placenta), and increased with decreasing PlGF values. With suboptimal glycaemic status (HbA1c ≥ 48 mmol/mol [6.5%] or time above range > 30%), increasing PlGF values were associated with heavier infants. Those with a healthy placenta (PlGF > 100) and suboptimal glycaemic control had a higher mean z score (2.45) than those with an unhealthy placenta (mean z score = 1.86). Similar relationships were seen when using sFlt-1/PlGF ratio as a marker for a healthy vs unhealthy placenta. Conclusions/interpretation: In women with type 1 diabetes, infant birthweight is influenced by both glycaemic status and placental function. In women with suboptimal glycaemia, infant birthweight was heavier when placentas were healthy. Suboptimal placental function should be considered in the setting of suboptimal glycaemia and apparently 'normal' birthweight. [ABSTRACT FROM AUTHOR]- Published
- 2021
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29. Technology and Pregnancy.
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Yamamoto, Jennifer M. and Murphy, Helen R.
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PREGNANCY , *GESTATIONAL diabetes , *SMALL for gestational age , *MEDICAL research , *MEDICAL sciences - Abstract
Results Case 1 presented at 4-weeks gestation in her second pregnancy, having had a previous miscarriage at 7-weeks gestation. They encompass improvements in our understanding of continuous glucose monitoring (CGM) in pregnancy, early data on the first commercially available closed-loop system used (off-license) during pregnancy, and advancements in our understanding of screening for GDM. As CGM in pregnancy continues to gain more widespread use, identifying these patterns using FDA may not only aid in the understanding of the pathophysiology of various glycemic-related complications but also help diabetes clinicians and women with diabetes identify and target patterns to reduce adverse outcomes. The manuscripts chosen for this year's article on technology and pregnancy demonstrated advances in our understanding of type 1, type 2, and gestational diabetes (GDM) in pregnant women. [Extracted from the article]
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- 2021
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30. 2020 NICE guideline update: Good news for pregnant women with type 1 diabetes and past or current gestational diabetes.
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Murphy, Helen R.
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BLOOD sugar monitoring , *GLYCEMIC control , *TYPE 1 diabetes , *MEDICAL protocols , *PREGNANCY outcomes , *INFORMATION resources , *GESTATIONAL diabetes , *PREGNANCY - Abstract
The article focuses on the good news for pregnant women with type 1 diabetes and past or current gestational diabetes. Topics discussed include the National Institute for Health and Care Excellence (NICE) reviewed the evidence and updated their recommendations on intermittently scanned and Continuous Glucose Monitoring (CGM) during pregnancy for type 1 diabetes women; and the NICE guidelines recommend offering CGM to all pregnant women with type 1 diabetes.
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- 2021
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31. Benefits of Real-Time Continuous Glucose Monitoring in Pregnancy.
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Yamamoto, Jennifer M. and Murphy, Helen R.
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BLOOD sugar monitoring , *TYPE 1 diabetes , *BLOOD sugar , *PREGNANCY outcomes , *LONGITUDINAL method - Abstract
In recent years, continuous glucose monitoring (CGM) has become increasingly available with the introduction of devices that are specifically approved for use during pregnancy. Evidence in the form of randomized-controlled trials and cohort studies continues to build support for the use of CGM during pregnancy to improve measures of maternal glycemia as well as obstetric and neonatal outcomes. Based on data from the CGM in pregnant women with type 1 diabetes (CONCEPTT) trial alongside a Swedish cohort study of real-world outcomes of pregnant women with type 1 diabetes, the UK National Institute for Health and Clinical Excellence (NICE) guidelines now recommend that real-time CGM be offered to all pregnant women with type 1 diabetes. Based on these guidelines, all pregnant individuals in the United Kingdom with type 1 diabetes will receive government-funded real-time CGM for a 12-month duration. These guidelines are a game-changer and will continue to facilitate more widespread access to CGM use in the United Kingdom and beyond. This review describes the role of CGM in the management of diabetes in pregnancy, discusses contemporary maternal glucose levels and their relationship with outcomes in diabetes pregnancies, and examines the high-quality, randomized-controlled trial and the real-world clinical data evaluating the impact of CGM use. [ABSTRACT FROM AUTHOR]
- Published
- 2021
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32. Technology and Pregnancy.
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Yamamoto, Jennifer M. and Murphy, Helen R.
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- *
INSULIN pumps , *BLOOD sugar monitors , *PRECONCEPTION care , *GESTATIONAL diabetes , *GLYCEMIC control , *PREGNANCY , *TECHNOLOGY , *MEDICAL sciences - Abstract
The manuscripts chosen for this year's technology and pregnancy article provide new insights into fetal exposure to maternal glucose during pregnancies complicated by gestational diabetes, and type 1 diabetes. Data relating continuous glucose monitoring (CGM) in type 1 diabetes pregnancy to neonatal outcomes are scarce. Healthcare providers and women with diabetes can focus on increasing CGM time in range during the latter half of pregnancy to reduce the risk of neonatal hypoglycemia. Women with gestational diabetes were more likely to develop type 2 diabetes or prediabetes than women without gestational diabetes (adjusted OR 3.44 [95% CI 2.84, 4.14]). [Extracted from the article]
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- 2020
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33. Erratum to: CONCEPTT: Continuous Glucose Monitoring in Women with Type 1 Diabetes in Pregnancy Trial: A multi-center, multi-national, randomized controlled trial - Study protocol
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Feig, Denice S., Asztalos, Elizabeth, Corcoy, Rosa, De Leiva, Alberto, Donovan, Lois, Hod, Moshe, Jovanovic, Lois, Keely, Erin, Kollman, Craig, McManus, Ruth, Murphy, Kellie, Ruedy, Katrina, Sanchez, J. Johanna, Tomlinson, George, and Murphy, Helen R.
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Adult ,Blood Glucose ,Adolescent ,Pregnancy in Diabetics ,Monitoring, Ambulatory ,Young Adult ,Study Protocol ,Diabetes mellitus type 1 ,Pregnancy ,Obstetrics and Gynaecology ,Birth Weight ,Humans ,Hypoglycemic Agents ,Insulin ,Continuous glucose monitoring ,Glycated Hemoglobin ,Blood Glucose Self-Monitoring ,Infant, Newborn ,Preconception ,Obstetrics and Gynecology ,Hypoglycemia ,Pregnancy Complications ,Diabetes Mellitus, Type 1 ,Research Design ,Randomized controlled trial ,Female ,Erratum - Abstract
Background Women with type 1 diabetes strive for optimal glycemic control before and during pregnancy to avoid adverse obstetric and perinatal outcomes. For most women, optimal glycemic control is challenging to achieve and maintain. The aim of this study is to determine whether the use of real-time continuous glucose monitoring (RT-CGM) will improve glycemic control in women with type 1 diabetes who are pregnant or planning pregnancy. Methods/design A multi-center, open label, randomized, controlled trial of women with type 1 diabetes who are either planning pregnancy with an HbA1c of 7.0 % to ≤10.0 % (53 to ≤ 86 mmol/mol) or are in early pregnancy (
- Published
- 2016
34. Longitudinal Continuous Glucose Monitoring Metrics During Healthy Pregnancy and Following Gastric Bypass.
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Murphy, Helen R.
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- *
GASTRIC bypass , *HYPERGLYCEMIA , *WEIGHT loss , *GLUCOSE , *PREGNANCY , *GESTATIONAL diabetes , *SMALL for gestational age - Abstract
The article discusses research which described longitudinal continuous glucose monitoring (CGM) metrics during healthy pregnancy and following Roux-en-Y gastric bypass (RYGB) in women aged 29 years. The study measured mean CGM glucose levels during the day and overnight throughout pregnancy, glycemic variability, median nocturnal CGM glucose in Bariatric Surgery and Consequences for Mother and Baby in Pregnancy (BAMBI) control participants, target glucose range, and pregnancy outcomes.
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- 2023
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35. Neurocognitive and behavioural outcomes in offspring exposed to maternal pre-existing diabetes: a systematic review and meta-analysis.
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Yamamoto, Jennifer M., Benham, Jamie L., Dewey, Deborah, Sanchez, J. Johanna, Murphy, Helen R., Feig, Denice S., and Donovan, Lois E.
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Aims/hypothesis: We performed a systematic review and meta-analysis to determine whether exposure to maternal pre-existing diabetes in pregnancy is associated with neurocognitive or behavioural outcomes in offspring. Methods: We searched MEDLINE, EMBASE, PsychINFO, the Cochrane Database of Systematic Reviews and Scopus for studies that examined any neurocognitive or behavioural outcomes in offspring of mothers with pre-existing diabetes in pregnancy in accordance with a published protocol (PROSPERO CRD42018109038). Title and abstract review, full-text review and data extraction were performed independently and in duplicate. Risk of bias was assessed using the Newcastle–Ottawa scale. Meta-analyses of summary measures were performed using random-effects models. Results: Nineteen articles including at least 18,681 exposed and 2,856,688 control participants were identified for inclusion. Exposure to maternal pre-existing diabetes in pregnancy was associated with a lower pooled intelligence quotient in the offspring (pooled weighted mean difference −3.07 [95% CI −4.59, −1.55]; I
2 = 0%) and an increased risk of autism spectrum disorders (effect estimate 1.98 [95% CI 1.46, 2.68]; I2 = 0%). There was also an increased risk of attention deficit/hyperactivity disorder (pooled HR 1.36 [95% CI 1.19, 1.55]; I2 = 0%), though this was based on only two studies. Although most studies were found to be high quality in terms of participant selection, in many studies, comparability of cohorts and adequacy of follow-up were sources of bias. Conclusions/interpretation: There is evidence to suggest that in utero exposure to maternal pre-existing diabetes is associated with some adverse neurocognitive and behavioural outcomes. It remains unclear what the role of perinatal factors is and the degree to which other environmental factors contribute to these findings. [ABSTRACT FROM AUTHOR]- Published
- 2019
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36. Pumps or Multiple Daily Injections in Pregnancy Involving Type 1 Diabetes: A Prespecified Analysis of the CONCEPTT Randomized Trial.
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Feig, Denice S., Corcoy, Rosa, Donovan, Lois E., Murphy, Kellie E., Barrett, Jon F. R., Sanchez, J. Johanna, Wysocki, Tim, Ruedy, Katrina, Kollman, Craig, Tomlinson, George, Murphy, Helen R., and CONCEPTT Collaborative Group
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TYPE 1 diabetes ,INJECTIONS ,GESTATIONAL diabetes ,PREGNANCY complications ,RANDOMIZED controlled trials ,BLOOD sugar analysis ,SUBCUTANEOUS injections ,BLOOD sugar ,BLOOD sugar monitoring ,COMPARATIVE studies ,DRUG administration ,INSULIN ,INSULIN pumps ,RESEARCH methodology ,EVALUATION of medical care ,MEDICAL cooperation ,PREGNANCY ,QUALITY of life ,RESEARCH ,RESEARCH funding ,EVALUATION research ,TREATMENT effectiveness - Abstract
Objective: To compare glycemic control, quality of life, and pregnancy outcomes of women using insulin pumps and multiple daily injection therapy (MDI) during the Continuous Glucose Monitoring in Women With Type 1 Diabetes in Pregnancy Trial (CONCEPTT).Research Design and Methods: This was a prespecified analysis of CONCEPTT involving 248 pregnant women from 31 centers. Randomization was stratified for pump versus MDI and HbA1c. The primary outcome was change in HbA1c from randomization to 34 weeks' gestation. Key secondary outcomes were continuous glucose monitoring (CGM) measures, maternal-infant health, and patient-reported outcomes.Results: At baseline, pump users were more often in stable relationships (P = 0.003), more likely to take preconception vitamins (P = 0.03), and less likely to smoke (P = 0.02). Pump and MDI users had comparable first-trimester glycemia: HbA1c 6.84 ± 0.71 vs. 6.95 ± 0.58% (51 ± 7.8 vs. 52 ± 6.3 mmol/mol) (P = 0.31) and CGM time in target (51 ± 14 vs. 50 ± 13%) (P = 0.40). At 34 weeks, MDI users had a greater decrease in HbA1c (-0.55 ± 0.59 vs. -0.32 ± 0.65%, P = 0.001). At 24 and 34 weeks, MDI users were more likely to achieve target HbA1c (P = 0.009 and P = 0.001, respectively). Pump users had more hypertensive disorders (P = 0.011), mainly driven by increased gestational hypertension (14.4 vs. 5.2%; P = 0.025), and more neonatal hypoglycemia (31.8 vs. 19.1%, P = 0.05) and neonatal intensive care unit (NICU) admissions >24 h (44.5 vs. 29.6%; P = 0.02). Pump users had a larger reduction in hypoglycemia-related anxiety (P = 0.05) but greater decline in health/well-being (P = 0.02).Conclusions: In CONCEPTT, MDI users were more likely to have better glycemic outcomes and less likely to have gestational hypertension, neonatal hypoglycemia, and NICU admissions than pump users. These data suggest that implementation of insulin pump therapy is potentially suboptimal during pregnancy. [ABSTRACT FROM AUTHOR]- Published
- 2018
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37. Day-and-Night Closed-Loop Insulin Delivery in a Broad Population of Pregnant Women With Type 1 Diabetes: A Randomized Controlled Crossover Trial.
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Stewart, Zoe A., Wilinska, Malgorzata E., Hartnell, Sara, O'Neil, Leanne K., Rayman, Gerry, Scott, Eleanor M., Barnard, Katharine, Farrington, Conor, Hovorka, Roman, and Murphy, Helen R.
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TYPE 1 diabetes ,PREGNANT women ,PREGNANCY complications ,INSULIN therapy ,HYPOGLYCEMIC agents ,PATIENTS ,BLOOD sugar ,CIRCADIAN rhythms ,COMPARATIVE studies ,CROSSOVER trials ,DELIVERY (Obstetrics) ,GESTATIONAL diabetes ,HYPERINSULINISM ,HYPOGLYCEMIA ,INSULIN ,INSULIN pumps ,EVALUATION of medical care ,PREGNANCY ,PUERPERIUM ,RESEARCH funding ,TIME ,TREATMENT effectiveness - Abstract
Objective: Despite advances in technology, optimal glucose control remains elusive and neonatal complications remain ubiquitous in type 1 diabetes (T1D) pregnancy. Our aim was to examine the safety, efficacy, and longer-term feasibility of day-and-night closed-loop insulin delivery.Research Design and Methods: We recruited 16 pregnant women (mean [SD]: age 32.8 [5.0] years, T1D duration 19.4 [10.2] years, HbA1c 8.0% [1.1], and BMI 26.6 [4.4] kg/m2) to an open-label, randomized, crossover trial. Participants completed 28 days of closed-loop and sensor-augmented pump (SAP) insulin delivery separated by a washout period. Afterward, participants could continue to use the closed-loop system up to 6 weeks postpartum. The primary end point was the proportion of time with glucose levels within the target range (63-140 mg/dL).Results: The proportion of time with glucose levels within target was comparable during closed-loop and SAP insulin delivery (62.3 vs. 60.1% [95% CI -4.1 to 8.3]; P = 0.47). Mean glucose and time spent hyperglycemic >140 mg/dL also did not differ (131.4 vs. 131.4 mg/dL [P = 0.85] and 36.6 vs. 36.1% [P = 0.86], respectively). During closed-loop, fewer hypoglycemic episodes occurred (median 8 [range 1-17] vs. 12.5 [1-53] over 28 days; P = 0.04) and less time at <63 mg/dL (1.6 vs. 2.7%; P = 0.02). Hypoglycemia <50 mg/dL (0.24 vs. 0.47%; P = 0.03) and low blood glucose index (1.0 vs. 1.4; P = 0.01) were lower. Less nocturnal hypoglycemia (2300-0700 h) during closed-loop therapy (1.1 vs. 2.7%; P = 0.008) and a trend toward higher overnight time in target (67.7 vs. 60.6%; P = 0.06) were found.Conclusions: Closed-loop insulin delivery was associated with comparable glucose control and significantly less hypoglycemia than SAP therapy. Larger, longer-duration multicenter trials are now indicated to determine clinical efficacy of closed-loop insulin delivery in T1D pregnancy and the impact on neonatal outcomes. [ABSTRACT FROM AUTHOR]- Published
- 2018
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38. Reply to Rowe et al Re: Managing hyperglycaemia during antenatal steroid administration, labour and birth in pregnant women with diabetes – an updated guideline from the Joint British Diabetes Society for Inpatient Care Dashora et al. Diabetic Medicine. 2022;39:e14744
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Dashora, Umesh, Levy, Nicholas, Dhatariya, Ketan, Willer, Nina, Castro, Erwin, and Murphy, Helen R.
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HYPERGLYCEMIA prevention ,CHILDBIRTH ,STEROIDS ,PREGNANT women ,MEDICAL protocols ,HYPOGLYCEMIA ,PRENATAL care ,LABOR (Obstetrics) ,DISEASE management ,DISEASE risk factors ,CHILDREN ,PREGNANCY - Published
- 2022
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39. Gestational diabetes.
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Piper, Leanne K., Stewart, Zoe, and Murphy, Helen R.
- Abstract
Gestational diabetes mellitus (GDM) is defined as hyperglycaemia that is diagnosed for the first time in the second or third trimester of pregnancy. It occurs in one in seven pregnancies worldwide and is associated with increased risk of adverse perinatal outcome, in particular, infant birth weight that is large for gestational age, increased infant adiposity, preeclampsia and preterm delivery, and increased delivery by caesarean section. This review focuses on the controversy regarding screening and diagnosis of GDM following development of the International Association of Diabetes and Pregnancy Study Groups (IADPSG) guidelines and the National Institute of Clinical Excellence (NICE) 2015 guidelines. It reviews the most recent research in to diet and exercise modification in prevention and management of GDM, pharmacological management and post-partum management to delay and/or prevent progression to type 2 diabetes. [ABSTRACT FROM AUTHOR]
- Published
- 2017
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40. CONCEPTT: Continuous Glucose Monitoring in Women with Type 1 Diabetes in Pregnancy Trial: A multi-center, multi-national, randomized controlled trial - Study protocol.
- Author
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Feig, Denice S., Asztalos, Elizabeth, Corcoy, Rosa, De Leiva, Alberto, Donovan, Lois, Hod, Moshe, Jovanovic, Lois, Keely, Erin, Kollman, Craig, McManus, Ruth, Murphy, Kellie, Ruedy, Katrina, Sanchez, J. Johanna, Tomlinson, George, Murphy, Helen R., and CONCEPTT Collaborative Group
- Subjects
BLOOD sugar monitoring ,DIABETES ,PREGNANT women ,PREGNANCY ,GLYCEMIC control - Abstract
Background: Women with type 1 diabetes strive for optimal glycemic control before and during pregnancy to avoid adverse obstetric and perinatal outcomes. For most women, optimal glycemic control is challenging to achieve and maintain. The aim of this study is to determine whether the use of real-time continuous glucose monitoring (RT-CGM) will improve glycemic control in women with type 1 diabetes who are pregnant or planning pregnancy.Methods/design: A multi-center, open label, randomized, controlled trial of women with type 1 diabetes who are either planning pregnancy with an HbA1c of 7.0 % to ≤10.0 % (53 to ≤ 86 mmol/mol) or are in early pregnancy (<13 weeks 6 days) with an HbA1c of 6.5 % to ≤10.0 % (48 to ≤ 86 mmol/mol). Participants will be randomized to either RT-CGM alongside conventional intermittent home glucose monitoring (HGM), or HGM alone. Eligible women will wear a CGM which does not display the glucose result for 6 days during the run-in phase. To be eligible for randomization, a minimum of 4 HGM measurements per day and a minimum of 96 hours total with 24 hours overnight (11 pm-7 am) of CGM glucose values are required. Those meeting these criteria are randomized to RT- CGM or HGM. A total of 324 women will be recruited (110 planning pregnancy, 214 pregnant). This takes into account 15 and 20 % attrition rates for the planning pregnancy and pregnant cohorts and will detect a clinically relevant 0.5 % difference between groups at 90 % power with 5 % significance. Randomization will stratify for type of insulin treatment (pump or multiple daily injections) and baseline HbA1c. Analyses will be performed according to intention to treat. The primary outcome is the change in glycemic control as measured by HbA1c from baseline to 24 weeks or conception in women planning pregnancy, and from baseline to 34 weeks gestation during pregnancy. Secondary outcomes include maternal hypoglycemia, CGM time in, above and below target (3.5-7.8 mmol/l), glucose variability measures, maternal and neonatal outcomes.Discussion: This will be the first international multicenter randomized controlled trial to evaluate the impact of RT- CGM before and during pregnancy in women with type 1 diabetes.Trial Registration: ClinicalTrials.gov Identifier: NCT01788527 Registration Date: December 19, 2012. [ABSTRACT FROM AUTHOR]- Published
- 2016
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41. Effectiveness of a Regional Prepregnancy Care Program in Women With Type 1 and Type 2 Diabetes.
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Murphy, Helen R., Roland, Jonathan M, Skinner, Timothy C., Simmons, David, Gurnell, Eleanor, Morrish, Nicholas J., Soo, Shiu-Ching, Kelly, Suzannah, Lim, Boon, Randall, Joanne, Thompsett, Sarah, and Temple, Rosemary C.
- Subjects
- *
WOMEN'S health services , *DIABETES , *TYPE 2 diabetes , *PREGNANCY , *ENDOCRINE diseases - Abstract
OBJECTIVE -- To implement and evaluate a regional prepregnancy care program in women with type 1 and type 2 diabetes. RESEARCH DESIGN AND METHODS -- Prepregnancy care was promoted among patients and health professionals and delivered across 10 regional maternity units. A prospective cohort study of 680 pregnancies in women with type 1 and type 2 diabetes was performed. Primary outcomes were adverse pregnancy outcome (congenital malformation, stillbirth, or neonatal death), congenital malformation, and indicators of pregnancy preparation (5 mg folic acid, gestational age, and A1C). Comparisons were made with a historical cohort (n = 613 pregnancies) from the same units during 1999-2004. RESULTS -- A total of 181 (27%) women attended, and 499 women (73%) did not attend prepregnancy care. Women with prepregnancy care presented earlier (6.7 vs. 7.7 weeks; P < 0.001), were more likely to take 5 mg preconception folic acid (88.2 vs. 26.7%; P < 0.0001) and had lower A1C levels (A1C 6.9 vs. 7.6%; P < 0.0001). They had fewer adverse pregnancy outcomes (1.3 vs. 7.8%; P < 0.009). Multivariate logistic regression confirmed that in addition to glycemic control, lack of prepregnancy care was independently associated with adverse outcome (odds ratio 0.2 [95% CI 0.05-0.89]; P = 0.03). Compared with 1999-2004, folic acid supplementation increased (40.7 vs. 32.5%; P = 0.006) and congenital malformations decreased (4.3 vs. 7.3%; P = 0.04). CONCLUSIONS -- Regional prepregnancy care was associated with improved pregnancy preparation and reduced risk of adverse pregnancy outcome in type 1 and type 2 diabetes. Prepregnancy care had benefits beyond improved glycemic control and was a stronger predictor of pregnancy outcome than maternal obesity, ethnicity, or social disadvantage. [ABSTRACT FROM AUTHOR]
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- 2010
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42. Integrating educational and technological interventions to improve pregnancy outcomes in women with diabetes.
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Murphy, Helen R.
- Subjects
- *
PREGNANCY , *CONCEPTION , *DIABETES , *PREGNANT women , *ENDOCRINE diseases - Abstract
A gap currently exists between our expectations of tight blood glucose control and the reality of safely achieving it before and during pregnancy. Technological and pharmaceutical advances will not in isolation prevent poor pregnancy outcomes without recognising the social, cultural and behavioural context of the women living with diabetes. Neither will behavioural and/or educational programmes completely overcome the fundamentally disordered metabolic pathways and physiological challenges of pregnancy. Improved integration of the technological, behavioural and educational aspects of diabetes care will pave the way for truly personalized, interdisciplinary diabetes management and ultimately improved pregnancy outcomes for women with diabetes and their infants. [ABSTRACT FROM AUTHOR]
- Published
- 2010
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43. Improving outcomes of pregnancy for women with type 1 and type 2 diabetes.
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Murphy, Helen R, Temple, Rosemary C, and Roland, Jonathan M
- Abstract
The pregnancy outcomes for women with type 1 diabetes remain poor with increased risk of major congenital malformation, stillbirth, premature delivery and perinatal death compared to the background maternity population. Despite clear evidence that women who attend prepregnancy care have improved blood glucose control with reduced risk of serious adverse outcomes, only a minority of women attend these clinics. For women with type 2 diabetes who are older, more obese and more likely to belong to an ethnic minority or live in an area of social deprivation, pregnancy outcomes are at least as poor as for women with type 1 diabetes. This is important as the prevalence of type 2 diabetes in women of reproductive years is increasing and even fewer women with type 2 diabetes attend prepregnancy care or take folic acid supplementation. Greater awareness regarding the risks among women with diabetes as well as primary and secondary healthcare professionals is required, if pregnancy outcomes are to be improved. [ABSTRACT FROM PUBLISHER]
- Published
- 2007
- Full Text
- View/download PDF
44. Response to Comment on Feig et al. Pumps or Multiple Daily Injections in Pregnancy Involving Type 1 Diabetes: A Prespecified Analysis of the CONCEPTT Randomized Trial. Diabetes Care 2018;41:2471-2479.
- Author
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Feig, Denice S., Corcoy, Rosa, Donovan, Lois E., Murphy, Kellie E., Barrett, Jon F. R., Sanchez, J. Johanna, Ruedy, Katrina, Kollman, Craig, Tomlinson, George, Murphy, Helen R., and CONCEPTT Collaborative Group
- Subjects
INSULIN pumps ,TYPE 1 diabetes ,MEDICAL personnel ,DIABETES ,PREGNANCY - Abstract
The authors present a response to a comment on the study regarding use of insulin pump or multiple daily injections in type 1 diabetes (T1D) pregnancy glycemic outcomes. The authors agree that more data are needed regarding the optimal implementation of insulin pump therapy during T1D. However, owing to some psycho social complexity, the authors claim that it is not practical to collect detailed data on patient-clinician relationship regarding insulin pump usage.
- Published
- 2019
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- View/download PDF
45. Diagnosis of gestational diabetes mellitus: falling through the net
- Author
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Meek, Claire L, Lewis, Hannah B, Patient, Charlotte, Murphy, Helen R, Simmons, David, Meek, Claire [0000-0002-4176-8329], and Apollo - University of Cambridge Repository
- Subjects
Adult ,Blood Glucose ,Cesarean Section ,Endocrinology, Diabetes and Metabolism ,Diabetes ,Infant, Newborn ,Pregnancy Outcome ,Glucose Tolerance Test ,Macrosomia ,Article ,Fetal Macrosomia ,Obstetrics ,Diabetes, Gestational ,Pregnancy ,Diagnosis ,Gestational ,Odds Ratio ,Prevalence ,Screening ,Internal Medicine ,Birth Weight ,Humans ,Female ,Retrospective Studies - Abstract
AIMS/HYPOTHESIS: Gestational diabetes mellitus (GDM) is associated with increased risks to mother and child, but globally agreed diagnostic criteria remain elusive. Identification of women with GDM is important, as treatment reduces adverse outcomes such as perinatal death, shoulder dystocia and neonatal hypoglycaemia. Recently, the UK's National Institute for Health and Care Excellence (NICE) recommended new diagnostic thresholds for GDM which are different from the International Association of the Diabetes and Pregnancy Study Groups (IADPSG) criteria endorsed by the WHO. The study aim was to assess neonatal and obstetric outcomes among women who would test positive for the IADPSG criteria but negative for the NICE 2015 criteria. METHODS: Data from 25,543 consecutive singleton live births (2004-2008) were obtained retrospectively from hospital records. Women were screened with a random plasma glucose (RPG; 12-16 weeks) and a 50 g glucose challenge test (GCT; 26-28 weeks). If RPG >7.0 mmol/l, GCT >7.7 mmol/l or symptoms were present, a 75 g OGTT was offered (n = 3,848). RESULTS: In this study, GDM prevalence was 4.13% (NICE 2015) and 4.62% (IADPSG). Women who 'fell through the net', testing NICE-negative but IADPSG-positive (n = 387), had a higher risk of having a large-for-gestational-age (LGA) infant (birthweight >90th percentile for gestational age; adjusted OR [95% CI] 3.12 [2.44, 3.98]), Caesarean delivery (1.44 [1.15, 1.81]) and polyhydramnios (6.90 [3.94, 12.08]) compared with women with negative screening results and no OGTT (n = 21,695). LGA risk was highest among women with fasting plasma glucose 5.1-5.5 mmol/l (n = 167): the mean birthweight was 350 g above that of the reference population and 37.7% of infants were LGA. CONCLUSIONS/INTERPRETATION: The IADPSG criteria identify women at substantial risk of complications who would not be identified by the NICE 2015 criteria.
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46. Dietary Intervention in Pregnant Women with Gestational Diabetes; Protocol for the DiGest Randomised Controlled Trial.
- Author
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Kusinski, Laura C., Murphy, Helen R., De Lucia Rolfe, Emanuella, Rennie, Kirsten L., Oude Griep, Linda M., Hughes, Deborah, Taylor, Roy, and Meek, Claire L.
- Abstract
Gestational diabetes mellitus (GDM) annually affects 35,000 pregnancies in the United Kingdom, causing suboptimal health outcomes to the mother and child. Obesity and excessive gestational weight gain are risk factors for GDM. The Institute of Medicine recommends weight targets for women that are overweight and obese, however, there are no clear guidelines for women with GDM. Observational data suggest that modest weight loss (0.6–2 kg) after 28 weeks may reduce risk of caesarean section, large-for-gestational-age (LGA), and maternal postnatal glycaemia. This protocol for a multicentre randomised double-blind controlled trial aims to identify if a fully controlled reduced energy diet in GDM pregnancy improves infant birthweight and reduces maternal weight gain (primary outcomes). A total of 500 women with GDM (National Institute of Health and Care Excellence (NICE) 2015 criteria) and body mass index (BMI) ≥25 kg/m
2 will be randomised to receive a standard (2000 kcal/day) or reduced energy (1200 kcal/day) diet box containing all meals and snacks from 28 weeks to delivery. Women and caregivers will be blinded to the allocations. Food diaries, continuous glucose monitoring, and anthropometry will measure dietary compliance, glucose levels, and weight changes. Women will receive standard antenatal GDM management (insulin/metformin) according to NICE guidelines. The secondary endpoints include caesarean section rates, LGA, and maternal postnatal glucose concentrations. [ABSTRACT FROM AUTHOR]- Published
- 2020
- Full Text
- View/download PDF
47. To Pump or Not to Pump in Pregnancy?
- Author
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Stewart, Zoe A. and Murphy, Helen R.
- Subjects
- *
MATERNAL health , *PRENATAL care , *TYPE 1 diabetes , *INSULIN pumps , *INSULIN , *LONGITUDINAL method , *EVALUATION of medical care , *PREGNANCY - Abstract
In this article, the author talks about the healthcare outcomes of pregnant women's suffering with type 1 diabetes, using insulin pump therapy which is associated with improved glucose control and discussed cost implications of such women's.
- Published
- 2017
- Full Text
- View/download PDF
48. Community-based pre-pregnancy care programme improves pregnancy preparation in women with pregestational diabetes
- Author
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Yamamoto, Jennifer M, Hughes, Deborah JF, Evans, Mark L, Karunakaran, Vithian, Clark, John DA, Morrish, Nicholas J, Rayman, Gerry A, Winocour, Peter H, Hambling, Clare, Harries, Amanda W, Sampson, Michael J, and Murphy, Helen R
- Subjects
Glucose ,Folic acid ,Pregnancy ,Pre-pregnancy care ,Diabetes ,Glycaemic control ,Community-based ,Antenatal ,Primary care ,3. Good health - Abstract
AIMS/HYPOTHESIS: Women with diabetes remain at increased risk of adverse pregnancy outcomes associated with poor pregnancy preparation. However, women with type 2 diabetes are less aware of and less likely to access pre-pregnancy care (PPC) compared with women with type 1 diabetes. We developed and evaluated a community-based PPC programme with the aim of improving pregnancy preparation in all women with pregestational diabetes. METHODS: This was a prospective cohort study comparing pregnancy preparation measures before and during/after the PPC intervention in women with pre-existing diabetes from 1 June 2013 to 28 February 2017. The setting was 422 primary care practices and ten National Health Service specialist antenatal diabetes clinics. A multifaceted approach was taken to engage women with diabetes and community healthcare teams. This included identifying and sending PPC information leaflets to all eligible women, electronic preconception care templates, online education modules and resources, and regional meetings and educational events. Key outcomes were preconception folic acid supplementation, maternal HbA1c level, use of potentially harmful medications at conception and gestational age at first presentation, before and during/after the PPC programme. RESULTS: A total of 306 (73%) primary care practices actively participated in the PPC programme. Primary care databases were used to identify 5075 women with diabetes aged 18-45 years. PPC leaflets were provided to 4558 (89.8%) eligible women. There were 842 consecutive pregnancies in women with diabetes: 502 before and 340 during/after the PPC intervention. During/after the PPC intervention, pregnant women with type 2 diabetes were more likely to achieve target HbA1c levels ≤48 mmol/mol (6.5%) (44.4% of women before vs 58.5% of women during/after PPC intervention; p = 0.016) and to take 5 mg folic acid daily (23.5% and 41.8%; p = 0.001). There was an almost threefold improvement in 'optimal' pregnancy preparation in women with type 2 diabetes (5.8% and 15.1%; p = 0.021). Women with type 1 diabetes presented for earlier antenatal care during/after PPC (54.0% vs 67.3% before 8 weeks' gestation; p = 0.003) with no other changes. CONCLUSIONS/INTERPRETATION: A pragmatic community-based PPC programme was associated with clinically relevant improvements in pregnancy preparation in women with type 2 diabetes. To our knowledge, this is the first community-based PPC intervention to improve pregnancy preparation for women with type 2 diabetes. DATA AVAILABILITY: Further details of the data collection methodology, individual clinic data and the full audit reports for healthcare professionals and service users are available from https://digital.nhs.uk/data-and-information/clinical-audits-and-registries/our-clinical-audits-and-registries/national-pregnancy-in-diabetes-audit .
49. Closed-loop insulin delivery during pregnancy complicated by type 1 diabetes
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Murphy, Helen R, Elleri, Daniela, Allen, Janet M, Harris, Julie, Simmons, David, Rayman, Gerry, Temple, Rosemary, Dunger, David B, Haidar, Ahmad, Nodale, Marianna, Wilinska, Malgorzata E, and Hovorka, Roman
- Subjects
Adult ,Blood Glucose ,Pregnancy in Diabetics ,Reproducibility of Results ,Biosensing Techniques ,3. Good health ,Circadian Rhythm ,Diabetes Mellitus, Type 1 ,Insulin Infusion Systems ,Pregnancy ,Hyperglycemia ,Humans ,Hypoglycemic Agents ,Insulin ,Female ,Algorithms - Abstract
OBJECTIVE: This study evaluated closed-loop insulin delivery with a model predictive control (MPC) algorithm during early (12-16 weeks) and late gestation (28-32 weeks) in pregnant women with type 1 diabetes. RESEARCH DESIGN AND METHODS: Ten women with type 1 diabetes (age 31 years, diabetes duration 19 years, BMI 24.1 kg/m(2), booking A1C 6.9%) were studied over 24 h during early (14.8 weeks) and late pregnancy (28.0 weeks). A nurse adjusted the basal insulin infusion rate from continuous glucose measurements (CGM), fed into the MPC algorithm every 15 min. Mean glucose and time spent in target (63-140 mg/dL), hyperglycemic (>140 to ≥ 180 mg/dL), and hypoglycemic (140 mg/dL) was 7% (0-40%) in early and 0% (0-6%) in late pregnancy (P = 0.25) and hypoglycemic (
50. Rapid model exploration for complex hierarchical data: application to pharmacokinetics of insulin aspart
- Author
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Goudie, Robert JB, Hovorka, Roman, Murphy, Helen R, and Lunn, David
- Subjects
insulin ,Reproducibility of Results ,Bayesian hierarchical models ,Models, Biological ,3. Good health ,Pregnancy Complications ,Markov chain Monte Carlo ,Diabetes Mellitus, Type 1 ,Pregnancy ,Data Interpretation, Statistical ,Humans ,Computer Simulation ,Female ,pharmacokinetics ,Monte Carlo Method ,Insulin Aspart ,variable selection - Abstract
We consider situations, which are common in medical statistics, where we have a number of sets of response data, from different individuals, say, potentially under different conditions. A parametric model is defined for each set of data, giving rise to a set of random effects. Our goal here is to efficiently explore a range of possible 'population' models for the random effects, to select the most appropriate model. The range of possible models is potentially vast, because the random effects may depend on observed covariates, and there may be multiple credible ways of partitioning their variability. Here, we consider pharmacokinetic (PK) data on insulin aspart, a fast acting insulin analogue used in the treatment of diabetes. PK models are typically nonlinear (in their parameters), often complex and sometimes only available as a set of differential equations, with no closed-form solution. Fitting such a model for just a single individual can be a challenging task. Fitting a joint model for all individuals can be even harder, even without the complication of an overarching model selection objective. We describe a two-stage approach that decouples the population model for the random effects from the PK model applied to the response data but nevertheless fits the full, joint, hierarchical model, accounting fully for uncertainty. This allows us to repeatedly reuse results from a single analysis of the response data to explore various population models for the random effects. This greatly expedites not only model exploration but also cross-validation for the purposes of model criticism. © 2015 The Authors. Statistics in Medicine published by John Wiley & Sons Ltd.
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