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Aims Methods Results Conclusions To determine the prognosis associated with severe hypoglycaemia (SH) and diabetic ketoacidosis (DKA) in adults presenting to a hospital emergency department (ED).Medical records of adults with type 1 (T1D) and type 2 (T2D) diabetes who attended the ED with SH and DKA between 1 January 2019 and 30 June 2023, were reviewed for comorbidities, long‐term survival, mortality and causes of death.A total of 429 episodes of DKA occurred in 293 people and 643 episodes of SH in 515 people. DKA predominated in T1D (77.6%) and SH in T2D (54.3%). In T2D, 32.3% of DKA events were associated with sodium‐glucose cotransporter‐2 inhibitor (SGLT2‐i) medication. In both SH and DKA, patients with T2D were older and had more comorbidities than T1D, particularly cardiorenal disease, heart failure, cognitive impairment and cancer (all p < 0.005). Compared with T1D, mortality was higher in T2D after SH (48.4% vs. 19.9%, p < 0.005) and after DKA (30.8% vs. 13.4%, p = 0.001) with shorter median times to fatal outcome (SH: 134 vs. 511 days; DKA: 43 vs. 266 days, both p < 0.005). Long‐term survival was lower (p < 0.005) and mortality risk was higher in T2D after index presentation with SH (HR 3.43 [95% CI: 2.43–4.84], p < 0.005) and DKA (HR 3.00 [95% CI: 1.77–5.10], p < 0.005). Irrespective of diabetes type, most causes of death in SH and DKA were non‐cardiovascular.SH and DKA events requiring hospital treatment herald a poor prognosis with greater mortality in T2D adults with multimorbidity. A significant number of DKA episodes in T2D occurred in people receiving SGLT2‐i medication. [ABSTRACT FROM AUTHOR]

Aims: The HypoCOMPaSS multi‐centre trial achieved improvement in hypoglycaemia awareness and 20‐fold reduction in severe hypoglycaemia (SH) in a cohort with long‐standing type 1 diabetes (T1D). All participants received 'my hypo compass' (MHC) brief structured psycho‐educational intervention in addition to optimisation of insulin delivery/glucose monitoring. In this 24‐week, prospective, single‐centre feasibility RCT, we piloted MHC as a sole intervention in comparison to standard clinical care alone (CON). Methods: Participants with T1D and impaired hypoglycaemia awareness (IAH) (Clarke score ≥4) were recruited. MHC comprised a group/individual 1–2 h face‐to‐face session followed by a telephone call and second face‐to‐face session at 4 weeks. Outcome measures at 24 weeks were compared with baseline. Results: Fifty‐two individuals provided consent for screening with 39 fulfilling eligibility criteria. Fifteen withdrew before any study intervention. Twenty‐four adults with (mean ± SD) T1D duration 41.0 ± 15.1 years commenced/completed the study (100% visit attendance); 12 randomised to MHC and 12 to CON. All had IAH at baseline and at 24 weeks. Annualised SH rate following MHC was 3.8 ± 19.0 (24 weeks) versus 12.6 ± 3.5 (Baseline) and in CON group 2.0 ± 19.0 (24 weeks) versus 4.6 ± 11.5 (Baseline). 'Immediate Action' for and 'Worry' about hyperglycaemia measured by the Hyperglycaemia Avoidance Scale appeared lower following MHC. Participants attended all study visits and reflected positively on the MHC intervention. Conclusions: Feasibility of MHC implementation without additional intervention has been demonstrated. MHC education was associated with positive changes in attitudes and behaviours with the potential to reduce SH risk. MHC provides a validated, simple, well‐received programme to fulfil the educational component within RCTs targeting problematic hypoglycaemia and as part of holistic clinical care. [ABSTRACT FROM AUTHOR]

Aims: We aim to compare and correlate Gold and Clarke questionnaire scores with hypoglycaemic symptomatic responses between insulin‐treated type 2 diabetes participants with and without IAH in a real‐life study. Methods: Insulin‐treated type 2 diabetes participants attending an outpatient diabetes clinic in Singapore were asked to complete the Gold and Clarke questionnaires, record capillary blood glucose (CBG) and hypoglycaemic symptoms for 4 weeks. Results: Data were collected from 153 participants (M:F = 98:55) with mean age 61.0 ± 9.4 years, duration of diabetes 19.5 ± 8.8 years and HbA1c 68 ± 17 mmol/mol (8.4 ± 1.5%). Gold and Clarke methods classified 19.6% and 26.8% of participants with IAH, respectively. Using CBG threshold of <3 mmol/L, significantly greater proportion of participants with intact awareness were experiencing autonomic symptoms than those with IAH with either method (Gold: 69% vs. 18%, p = 0.006; Clarke: 85% vs. 46%, p = 0.010). Significantly greater proportion of participants with IAH experienced no hypoglycaemia symptoms than those with intact awareness (Gold: 3.4% vs. 36%, p = 0.015; Clarke: 3.7% vs. 31%, p = 0.031). Participants with IAH had significantly higher rates of severe hypoglycaemia in the preceding year compared to those without (Gold: 17% vs. 3.3%; Clarke: 15% vs. 2.7%, p = 0.012). Conclusions: Gold and Clarke questionnaires are appropriate tools in ascertaining IAH status in insulin‐treated type 2 diabetes participants. This is the first time whereby the hypoglycaemia symptomology has robustly validated the Gold and Clarke questionnaire in insulin‐treated type 2 diabetes participants. [ABSTRACT FROM AUTHOR]

Aims: Impaired awareness of hypoglycaemia (IAH) has been reported to affect up to a third of people with type 1 diabetes. Whether the increased use of sensor technology has changed its prevalence remains unknown. The aim of this study was to investigate the current prevalence of IAH and its change over time in a cohort of individuals with type 1 diabetes. Methods: IAH was assessed using the modified Clarke questionnaire in adults with type 1 diabetes. Participants were recruited from the diabetes outpatient clinic from February 2020 through April 2021. The scores were compared to similar data collected during previous assessments in 2006, 2010 and 2016 respectively. Results: A total of 488 individuals (51.2% male) with a mean (±SD) age of 51.3 ± 15.9 years, median [Q1–Q3] diabetes duration of 30 [16–40] years and mean HbA1c of 60 ± 12 mmol/mol (7.7 ± 1.1%) were included. Sensors were used by 85% of the study population. IAH was present among 78 (16.0%) participants, whereas 86 (17.6%) participants had a history of severe hypoglycaemia. By comparison, the prevalence of IAH equalled 32.5% in 2006, 32.3% in 2010 and 30.1% in 2016 (p for trend <0.001), while the proportion of individuals reporting severe hypoglycaemia equalled 21.2%, 46.7% and 49.8% respectively (p for trend 0.010). Comparing sequential assessments over time, the proportion of individuals with persistent IAH decreased from 74.0% and 63.6% between 2006 and 2016 to 32.5% in 2020. Conclusions: Among individuals with type 1 diabetes and high use of sensor technology, the current prevalence of IAH was 16%, about 50% lower as compared to previous years. [ABSTRACT FROM AUTHOR]

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 <3.5 mmol/L) and exhibited more glycaemic variability at 12 weeks gestation. Higher overall HFS‐II scores were associated with a higher risk of maternal severe hypoglycaemia episodes (Rate Ratio 1.78, 95% CI 1.39–2.27). Women with impaired awareness of hypoglycaemia had less maternal weight gain but there were no differences in neonatal outcomes between women with impaired awareness of hypoglycaemia and normal hypoglycaemia awareness. Higher HFS‐II scores were associated with more nephropathy (Odds Ratio 1.91, 95% CI 1.06–3.4). CGM use after 12 weeks was not associated with the number of episodes of severe hypoglycaemia (RR 0.75, 95% CI 0.49–1.15; p = 0.18). Conclusions: In pregnant women with type 1 diabetes, impaired awareness of hypoglycaemia is associated with more maternal severe hypoglycaemia episodes and more fear of hypoglycaemia. Having impaired awareness of hypoglycaemia and/or fear of hypoglycaemia should alert clinicians to this increased risk. Reassuringly, there was no increase in adverse neonatal outcomes. [ABSTRACT FROM AUTHOR]

Objective: Prior to the Continuous Monitoring and Control of Hypoglycaemia (COACH) study described herein, no study had been powered to evaluate the impact of non‐adjunctive RT‐CGM use on the rate of debilitating moderate or severe hypoglycaemic events. Research Design and Methods: In this 12‐month observational study, adults with insulin‐requiring diabetes who were new to RT‐CGM participated in a 6‐month control phase where insulin dosing decisions were based on self monitoring of blood glucose values, followed by a 6‐month phase where decisions were based on RT‐CGM data (i.e. non‐adjunctive RT‐CGM use); recommendations for RT‐CGM use were made according to sites' usual care. The primary outcome was change in debilitating moderate (requiring second‐party assistance) and severe (resulting in seizures or loss of consciousness) hypoglycaemic event frequency. Secondary outcomes included changes in HbA1c and diabetic ketoacidosis (DKA) frequency. Results: A total of 519 participants with mean (SD) age 50.3 (16.1) years and baseline HbA1c 8.0% (1.4%) completed the study, of whom 32.8% had impaired hypoglycaemia awareness and 33.5% had type 2 diabetes (T2D). The mean (SE) per‐patient frequency of hypoglycaemic events decreased by 63% from 0.08 (0.016) during the SMBG phase to 0.03 (0.010) during the RT‐CGM phase (p = 0.005). HbA1c decreased during the RT‐CGM phase both for participants with type 1 diabetes (T1D) and T2D and there was a trend towards larger reductions among individuals with higher baseline HbA1c. Conclusions: Among adults with insulin‐requiring diabetes, non‐adjunctive use of RT‐CGM data is safe, resulting in significantly fewer debilitating hypoglycaemic events than management using SMBG. [ABSTRACT FROM AUTHOR]

Diabet. Med. 27, 666–672 (2010) Objective Impaired awareness of hypoglycaemia (IAH) is a major risk factor for severe hypoglycaemia in Type 1 diabetes. Although biochemical hypoglycaemia is asserted to be more frequent in IAH, this has not been estimated accurately. The aim of this study was to use Continuous Glucose Monitoring (CGM) to quantify hypoglycaemia in IAH and evaluate its use in identifying impaired awareness of hypoglycaemia. Methods Ninety-five patients with Type 1 diabetes were classified as having normal ( n = 74) or impaired awareness ( n = 21) using an established method of assessing hypoglycaemia awareness. Hypoglycaemia exposure was assessed prospectively over 9–12 months using weekly 4-point capillary home blood glucose monitoring (HBGM), 5 days of CGM and prospective reporting of severe hypoglycaemia. The frequencies of biochemical and severe hypoglycaemia were compared in patients with normal and impaired awareness of hypoglycaemia. Results Patients with impaired awareness had a 3-fold higher incidence of severe hypoglycaemia than those with normal awareness [incidence rate ratio (IRR) 3.37 (95% CI 1.30–8.7); P = 0.01] and 1.6-fold higher incidence of hypoglycaemia on weekly HBGM [IRR 1.63 (95% CI 1.09–2.44); P = 0.02]. No significant differences were observed with CGM [IRR for sensor glucose ≤ 3.0 mmol/l 1.47 (95% CI 0.91–2.39); P = 0.12; IRR for sensor glucose ≤ 2.2 mmol/l 1.23 (95% CI 0.76–1.98); P = 0.40]. Conclusions Patients with Type 1 diabetes with impaired awareness had a 3-fold higher risk of severe hypoglycaemia and 1.6-fold higher incidence of biochemical hypoglycaemia measured with weekly glucose monitoring compared with normal awareness, but 5 days of CGM did not differentiate those with impaired from those with normal awareness. [ABSTRACT FROM AUTHOR]

Aims Severe hypoglycaemia is a significant problem in pregnant women with Type 1 diabetes. We explored whether frequent severe hypoglycaemia during pregnancy in women with Type 1 diabetes is related to placental growth hormone (GH) and insulin-like growth factor I (IGF-I) levels. Methods A prospective, observational study of 107 consecutive pregnant women with Type 1 diabetes. Blood samples were drawn for IGF-I and placental GH analyses at 8, 14, 21, 27 and 33 weeks. Severe hypoglycaemic events were reported within 24 h. Results Eleven women (10%) experienced frequent severe hypoglycaemia (≥ 5 events), accounting for 60% of all events. Throughout pregnancy, IGF-I levels were 25% lower in these women ( P < 0.005) compared with the remaining women, despite similar placental GH levels. Eighty per cent of the severe hypoglycaemic events occurred before 20 weeks when IGF-I levels were at their lowest. This finding was not explained by differences in insulin dose, median plasma glucose levels or glycated haemoglobin. History of severe hypoglycaemia the year preceding pregnancy and impaired hypoglycaemia awareness—being the only predictors of frequent severe hypoglycaemia in a logistic regression analysis—were not associated with IGF-I or placental GH levels at 8 weeks. Conclusions In women with Type 1 diabetes experiencing frequent severe hypoglycaemia during pregnancy, IGF-I levels are significantly lower compared with the remaining women despite similar placental GH levels. IGF-I levels are lowest in early pregnancy where the incidence of severe hypoglycaemia is highest. IGF-I may be a novel factor of interest in the investigation of severe hypoglycaemia in patients with Type 1 diabetes. [ABSTRACT FROM AUTHOR]

Aims To assess the outcome of a Diabetes Treatment and Teaching Programme (DTTP) on glycated haemoglobin (HbA1c), severe hypoglycaemia (SH) and severe ketoacidosis (SKA) in adolescents and young adults with Type 1 diabetes. Methods Quality-assurance project with assessment of participants 1 year after participation in a DTTP (5-day inpatient course, groups ≤ 10 patients, fixed curriculum of education/training, introduction of dietary freedom). Before–after analyses of participants aged 12–15, 15–18, 18–21 and 21–24 years. Main outcome measures were HbA1c, SH and SKA. Results For the 1592 participants, aged 12 to 24 years, mean age at enrolment was 19 ± 3 years, mean duration of diabetes was 7.3 ± 5.4 (range 0.3–24) years, mean baseline HbA1c declined from 8.8 ± 2.3% to 8.1 ± 2.0%. The incidence of SH was 0.31 vs. 0.11 events/patient/year; the incidence of SKA 0.17 vs. 0.07 events/patient/year. In mixed effects models taking into account effects of centres, age and diabetes duration, the mean difference was −0.64%[ P < 0.001, 95% confidence interval (CI) −0.79 to −0.5] for HbA1c, −0.2 events/patient/year ( P < 0.0001, 95% CI −0.28 to −0.12) for SH and −0.1 events/patient/year ( P < 0.0001, 95% CI −0.14 to −0.06) for SKA. Conclusions Adolescents and young adults with Type 1 diabetes benefit from participation in a standard DTTP for flexible, intensive insulin therapy and dietary freedom. [ABSTRACT FROM AUTHOR]

Aim To determine potential for amelioration of recurrent severe hypoglycaemia without worsening in overall control in individuals with long-standing Type 1 diabetes (T1DM). Methods Twenty-one people with T1DM characterized by altered hypoglycaemia awareness and debilitating severe hypoglycaemia were randomized in a pilot 24-week prospective study to optimized analogue therapy (ANALOGUE; lispro/glargine); continuous subcutaneous insulin infusion therapy (CSII; lispro); or re-education with relaxation of blood glucose targets on existing conventional insulin regimen (EDUCATION). Glycaemic profiles and duration of biochemical hypoglycaemia were measured by continuous subcutaneous glucose monitoring and self-monitored blood glucose. Results Further severe hypoglycaemia was prevented in five participants (71%) in each group ( P = 0.06). Incidence of severe hypoglycaemia was: 0.6 (ANALOGUE), 0.9 (CSII), and 3.7 (EDUCATION) episodes per patient year. Restoration of hypoglycaemia awareness was confirmed by validated questionnaire in three (43%) ANALOGUE, four (57%) CSII and five (71%) EDUCATION patients. Glycated haemoglobin (HbA1c) was significantly improved in the ANALOGUE group between weeks 0 and 24 (8.6 ± 1.1 vs. 7.6 ± 0.8%; P = 0.04 for change). Non-significant improvement was seen in the CSII group (8.5 ± 1.9 vs. 7.4 ± 1.0%; P = 0.06). No change in HbA1c was seen in the EDUCATION group (8.5 ± 1.1 vs. 8.3 ± 1.0%; P = 0.54). There were no episodes of diabetic ketoacidosis or any other adverse events in any group. Conclusions In this pilot randomized trial comparing optimized ANALOGUE, CSII or EDUCATION alone in unselected individuals with recurrent severe hypoglycaemia, we show potential for restoring hypoglycaemia awareness and preventing further severe hypoglycaemia with concomitant improvement in glycaemic control in ANALOGUE and CSII groups. [ABSTRACT FROM AUTHOR]

Abstract Aims To study the prevalence of severe hypoglycaemia (SH) in relation to risk factors in Type 1 diabetic (T1 DM) patients over a period of 14 years. Methods We performed a cross-sectional survey of a cohort of 178 T1 DM patients registered at our out-patient clinic in 1984 to be repeated in 1998. An identical questionnaire was sent to the patients in the beginning of 1985 and 1999, respectively, regarding the problem of SH in the preceding year. Additional clinical data were obtained from the patients’ medical records on insulin treatment, long-term complications, morbidity, and co-medication. Results At follow up, the use of multiple insulin injection therapy had increased from 71% to 98% (P < 0.001) and daily self-monitoring of blood glucose (SMBG) from 17% to 48% (P < 0.001). Twenty-seven percent were treated with direct-acting insulin analogues in 1998. An increasing number of patients reported unawareness of hypoglycaemia, 54% vs. 40% (P < 0.01), and nocturnal events were more frequent, 83% vs. 76% (P < 0.05). The prevalence of SH had increased from 17% to 27% (P < 0.05) and a slight decrease of HbA1c , 7.6% to 7.4% (P < 0.05) was documented. Conclusion We conclude that despite more frequent use of multiple injection therapy and SMBG, the prevalence of SH has increased by > 50% over 14 years. A multiple logistic regression analysis of risk factors for SH explained less than 10% of the variance, implicating only unawareness of hypoglycaemia and HbA1c . Diabet. Med. 20, 216–219 (2003). [ABSTRACT FROM AUTHOR]

SummaryAims A comparison of the frequency of severe hypoglycaemia leading to hospital admission in people with Type 2 diabetes mellitus (DM) treated with long vs. short-acting sulphonylureas. Methods A community based study over a 12-year period in the population of the city of Basle, Switzerland. The number of diabetic patients treated with oral hypoglycaemic agents was established on the basis of tablet consumption and a defined daily dose, e.g. 7.5 mg for glibenclamide, and 50 mg for glibornuride. Results Twenty-eight Type 2 diabetic patients were admitted for severe hypo- glycaemia, with a median age of 73 years. There were no deaths. Sixteen of these admissions were patients treated with long-acting sulphonylureas and 12 were patients treated with short-acting forms. Only 23.5% of the population with Type 2 DM in Basle were treated with long-acting sulphonylureas. With 30 345 person-years of observation, the incidence of severe hypoglycaemia was 2.24 per 1000 person-years for long-acting sulphonylureas vs. 0.75 per 1000 person-year for short-acting forms, odds ratio 3.01 (95% confidence interval 1.35–6.77). Decreased food intake (nine patients) was a major contributing factor. Conclusions Severe hypoglycaemia leading to hospital admission is more common in elderly Type 2 diabetic patients treated with long-acting compared to short-acting sulphonylureas. Such long-acting sulphonylureas should be avoided. [ABSTRACT FROM AUTHOR]

Aims The aim of this study was to identify risk factors for severe hypoglycaemia (SH) in pregnancy in Type 1 diabetes, including associations with pregnancy planning and glycaemic control. Methods Clinical data including details of the pregnancy and its outcome, glycaemic control, frequency of SH and evidence of pregnancy planning were collected prospectively as part of a national audit of 160 pregnancies in women with Type 1 diabetes. Results An episode of SH was experienced by 29.4% of women at some point during the pregnancy, with the percentage of women experiencing SH decreasing from 21.9% in the first trimester to 18.1% in trimester 2 and 10.9% in trimester 3. Longer duration of diabetes was associated with increased frequency of SH during pregnancy ( r = 0.191, P = 0.012). A greater fall in glycated haemoglobin (HbA1c) between pre-pregnancy and the first trimester was not associated with increased risk of SH in trimester 1. Planned pregnancies had better glycaemic control but higher risk of SH in trimester 1 ( P = 0.047). Women with pre-pregnancy retinopathy and current smokers had an increased risk of SH in trimester 3 ( P = 0.029, P = 0.033). Conclusions SH is common during pregnancy and particularly in the first trimester. Planning pregnancy does not decrease the risk of SH. Improvements in glycaemic control at the start of pregnancy do not appear to increase the risk of SH. Education of women and their partners about the risks of SH and its management is essential when planning pregnancy. [ABSTRACT FROM AUTHOR]