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Objective For youth with type 1 diabetes (T1D), the early adolescent period is associated with worsening diabetes management and high rates of negative psychosocial issues, including depressive symptoms and family conflict. Alternative clinical models may help improve both diabetes and psychosocial outcomes. Our study aims to investigate whether Team Clinic, a shared medical appointment model developed specifically for adolescents with T1D, will improve psychosocial outcomes for middle school-aged youth. Methods Youth with T1D, 11-13 years of age, and their caregivers, participated in a randomized controlled trial comparing Team Clinic to traditional clinic visits (control group). Diabetes characteristics were obtained at every visit. Participants and caregivers completed depression screening and family conflict questionnaires at baseline and end of study. Changes in mean scores on clinical and psychosocial outcomes from baseline to end of study were compared between groups using linear mixed-effects models. Results Eighty-six youth (51% female; 74% White; 10% Hispanic) completed at least one visit during the twelve-month study period. At the end of the study, control group participants reported increases in Emotional Problems compared to Team Clinic participants, including higher levels of Negative Mood/Physical Symptoms (p=0.02). Team Clinic participants reported reduced family conflict surrounding diabetes at study end, compared to control group participants (p=0.03). Caregivers did not report change in depressive symptoms or family conflict during the study. Hemoglobin A1C levels did not change over time in either group. Conclusions Participation in Team Clinic was associated with improved psychosocial outcomes in middle school-aged participants with T1D. This article is protected by copyright. All rights reserved.

T2D in youth remains challenging to manage and there is need for an expanded treatment armamentarium. The DINAMO study was designed to overcome recruitment difficulties that plagued previous T2D studies in youth. Within 3 years, DINAMO enrolled 158 patients aged to Disclosure L.M. Laffel: Advisory Panel; Medtronic, Roche Diabetes Care. Consultant; Boehringer Ingelheim International GmbH, Dexcom, Inc., Dompé, Insulet Corporation, Janssen Pharmaceuticals, Inc., Lilly Diabetes, Novo Nordisk, Provention Bio, Inc. T. Danne: Consultant; Abbott, AstraZeneca, Boehringer Ingelheim International GmbH, Dexcom, Inc., Lilly, Medtronic, Novo Nordisk, Roche Pharmaceuticals, Sanofi, Ypsomed AG. Research Support; Abbott, AstraZeneca, Boehringer Ingelheim International GmbH, Dexcom, Inc., Lilly, Medtronic, Novo Nordisk, Roche Pharmaceuticals, Sanofi, Ypsomed AG. Stock/Shareholder; DreaMed Diabetes, Ltd. W.V. Tamborlane: Consultant; AstraZeneca, Boehringer Ingelheim International GmbH, Medtronic, Novo Nordisk, Sanofi, Takeda Pharmaceutical Company Limited. G.J. Klingensmith: Research Support; AstraZeneca, Novo Nordisk, Takeda Pharmaceutical Company Limited. Stock/Shareholder; Dexcom, Inc., Insulet Corporation, Tandem Diabetes Care, Inc. C. Schroeder: Employee; Boehringer Ingelheim Inc. D. Neubacher: Employee; Boehringer Ingelheim International GmbH. N. Soleymanlou: Employee; Boehringer Ingelheim Pharmaceuticals Inc., Boehringer Ingelheim Pharmaceuticals Inc. J. Marquard: Employee; Boehringer Ingelheim Inc. P. Zeitler: Consultant; Boehringer Ingelheim International GmbH, Daiichi Sankyo, Eli Lilly and Company, Janssen Pharmaceuticals, Inc., Merck & Co., Inc., Novo Nordisk, Takeda Pharmaceutical Company Limited. S.M. Willi: Advisory Panel; Boehringer Ingelheim International GmbH, Medtronic. Research Support; Jaeb Center for Health Research, Provention Bio, Inc. Other Relationship; National Institute of Diabetes and Digestive and Kidney Diseases. Funding Boehringer Ingelheim

Objectives This study sought to: (a) assess the prevalence of diabetes complications and comorbidities screening as recommended by the American Diabetes Association (ADA) for youth and young adults (YYAs) with type 1 diabetes (T1D), (b) examine the association of previously measured metabolic status related to diabetes complications with receipt of recommended clinical screening, and (c) examine the association of satisfaction with diabetes care with receipt of recommended clinical screening. Methods The study included 2172 SEARCH for Diabetes in Youth participants with T1D (>10 years old, diabetes duration >5 years). Mean participant age was 17.7 ± 4.3 years with a diabetes duration of 8.1 ± 1.9 years. Linear and multinomial regression models were used to evaluate associations. Results Sixty percent of participants reported having three or more hemoglobin A1c (HbA1c) measurements in the past year. In terms of diabetes complications screening, 93% reported having blood pressure measured, 81% having an eye examination, 71% having lipid levels checked, 64% having a foot exam, and 63% completing albuminuria screening in accordance with ADA recommendations. Youth known to have worse glycemic control in the past had higher odds of not meeting HbA1c screening criteria (OR 1.11, 95% CI = 1.05, 1.17); however, after adjusting for race/ethnicity, this was no longer statistically significant. Greater satisfaction with diabetes care was associated with increased odds of meeting screening criteria for most of the ADA-recommended measures. Conclusions Efforts should be made to improve diabetes complications screening efforts for YYAs with T1D, particularly for those at higher risk for diabetes complications.

Purpose To assess the impact of a home telemedicine clinic model (CoYoT1 Clinic) on psychosocial and behavioral outcomes designed for young adults (YAs) with type 1 diabetes (T1D). Methods YAs self-selected to participate in the CoYoT1 Clinic or serve as a usual care control. CoYoT1 Clinic visits consisted of an individual appointment with a provider and a group appointment with other YAs with T1D using home telemedicine. Psychosocial and behavioral functioning was assessed by 4 measures: Diabetes Distress Scale, Self-Efficacy for Diabetes Scale, Self-Management of Type 1 Diabetes in Adolescence Scale, and Center for Epidemiologic Studies Depression Scale. Results Forty-two patients participated in the CoYoT1 Clinic and 39 patients served as controls. CoYoT1 participants reported lower levels of distress ( P = .03), increased diabetes self-efficacy ( P = .01), and improved ability to communicate with others about diabetes ( P = .04) over the study period compared to controls. YA males in the control group reported increases in depressive symptoms ( P = .03) during the study period, but CoYoT1 participants showed no changes. Conclusion Group home telemedicine for YAs with T1D positively affects diabetes distress, self-efficacy, and diabetes-specific communication. These positive findings have the potential to also affect the YAs’ long-term diabetes outcomes. Further investigation of the model is needed.

OBJECTIVE Type 2 diabetes in the U.S. is more prevalent in youth of minority racial-ethnic background, but disparities in health outcomes have not been examined in this population. RESEARCH DESIGN AND METHODS We examined racial-ethnic differences in the initial presentation and subsequent comorbidities in 1,217 youth with type 2 diabetes (63% girls) enrolled in the Pediatric Diabetes Consortium (PDC) Registry from February 2012 to June 2018. Demographic and clinical data were collected from medical records and participant self-report. RESULTS Overall, the mean age at presentation was 13.4 ± 2.4 years, and BMI was 35.0 ± 9.4 kg/m2. HbA1c was higher and C-peptide was lower in non-Hispanic Black (NHB) and Hispanic (H) youth compared with non-Hispanic White (NHW) youth. NHB were three times as likely to present in diabetic ketoacidosis (19%) versus NHW (6.3%) and H (7.5%), and NHB and H both had a worse HbA1c trajectory compared with NHW peers. Microalbuminuria was documented in 11%, hypertension in 34%, and dyslipidemia in 42% of Registry participants, with no significant difference among racial-ethnic groups. Nonalcoholic fatty liver disease (NAFLD) was diagnosed in 9% and 11% of H and NHW, respectively, versus 2% in NHB. CONCLUSIONS NHB and H youth with type 2 diabetes presented with worse metabolic control and had persistently worse HbA1c trajectories compared with NHW. Comorbidities exist in a large percentage of these youth independent of race-ethnicity, except for NAFLD being less prevalent in NHB. Greater efforts are needed to mitigate racial-ethnic disparities at diagnosis and in the management of youth with type 2 diabetes.

Background: Given the paucity of treatment options for youth with type 2 diabetes (T2D), insulin is commonly used to rapidly reverse gluco-toxicity. Subsequently, some youth with short duration T2D can be weaned off insulin soon after diagnosis. We analyzed data from the Pediatric Diabetes Consortium (PDC) Registry to determine how long glycemic control is maintained off insulin. Methods: Youth with T2D in the PDC Registry on metformin alone or lifestyle therapy alone upon registry enrollment but had previously been on insulin were included in this study (N=183). The primary outcome was time to treatment failure, defined by need to restart insulin or other diabetes medication (including metformin). Clinical data at enrollment and follow-up were analyzed using logistic regression to assess risk factors for treatment failure. Results: Of participants who had previously been on insulin therapy (58% female, 53% Hispanic, mean age 15 ± 2 years, median diabetes duration 1.7 years), 54% (98/183) experienced treatment failure. In the subgroup on metformin alone at enrollment (N=140), 45% restarted insulin, while in the lifestyle alone subgroup (N=43), 81% restarted insulin or other diabetes medication. Time to treatment failure was a median of 1.2 years. High HbA1c (mean 7.7% vs. 6.1% in the treatment failure group vs. non-failure group; p Conclusion: Youth with T2D previously treated with insulin have a high treatment failure rate on lifestyle or metformin therapy alone and are likely to restart insulin therapy. Youth with T2D should be monitored closely for worsening glycemic control. Disclosure R. Wolf: None. P. Cheng: None. R.L. Gal: None. L.C. Beaulieu: None. C. Kollman: Other Relationship; Self; Dexcom, Inc., Tandem Diabetes Care. E.M. Isganaitis: None. S.N. Magge: None. L.D. Mastrandrea: Board Member; Self; American Academy of Pediatrics. Research Support; Self; AstraZeneca, JDRF, Novo Nordisk Inc., Sanofi-Aventis. G.J. Klingensmith: Research Support; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Novo Nordisk Inc., Takeda Pharmaceutical Company Limited. W.V. Tamborlane: Consultant; Self; AstraZeneca, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Medtronic, Novo Nordisk Inc., Sanofi US. Other Relationship; Self; Eisai Inc., MannKind Corporation. M.A. Van Name: None. Funding Boehringer Ingelheim; Novo Nordisk; Takeda Pharmaceutical Company Limited

Summary Background One in three adolescents and young adults with type 1 diabetes have at least one early diabetes-related complication or comorbidity. We aimed to examine the prevalence and pattern of co-occurring complications in this population, as well as the related risk factors. Methods This observational cohort study includes data from individuals diagnosed with type 1 diabetes before age 20 years who participated in the SEARCH for Diabetes in Youth Study across five sites in the USA. We assessed sociodemographic and metabolic risk factors at baseline and at follow-up, and diabetes complications at follow-up. A frequency analysis was done to examine the difference in observed versus expected prevalence (calculated using a contingency table assuming independence across cells) of co-occurring complications or comorbidities. A cluster analysis was done to identify unique clusters of participants based on demographic characteristics and metabolic risk factors. Findings 1327 participants who completed the follow-up visit were included in the frequency analysis. The mean age was 10·1 (SD 3·9) years at the time of type 1 diabetes diagnosis and 18·0 (4·1) years at follow-up. At a mean diabetes duration of 7·8 [SD 1·9] years, co-occurrence of any two or more complications was observed in 78 (5·9%) participants, more frequently than expected by chance alone (58 [4·4%], p=0·015). Specifically, the complications that co-occurred more frequently than expected were retinopathy and diabetic kidney disease (11 [0·8%] vs three [0·2%]; p=0·0007), retinopathy and arterial stiffness (13 [1·0%] vs four [0·3%]; p=0·0016), and arterial stiffness and cardiovascular autonomic neuropathy (24 [1·8%] vs 13 [1·0%]; p=0·015). We identified four unique clusters characterised by progressively worsening metabolic risk factor profiles (longer duration of diabetes and higher glycated haemoglobin, non-HDL cholesterol, and waist-to-height ratio). The prevalence of at least two complications increased across the clusters (six [2·3%] of 261 in the low-risk cluster, 32 [6·3%] of 509 in the moderate-risk cluster, 28 [8%] of 348 in the high-risk cluster, and five [20·8%] of 24 in the highest-risk cluster). Compared with the low-risk and moderate-risk clusters, the high-risk and highest-risk clusters were characterised by a lower proportion of participants who were non-Hispanic white, and a higher proportion of participants who had a household income below US$50 000 and did not have private health insurance. Interpretation Early complications co-occur in adolescents and young adults with type 1 diabetes more frequently than expected. Identification of individuals with adverse risk factors could enable targeted behavioural or medical interventions that reduce the likelihood of early development of lifelong diabetes-related morbidity. Funding US Centers for Disease Control and Prevention, US National Institutes of Health.

BACKGROUND Insulin degludec/insulin aspart (IDegAsp) is a fixed soluble co-formulation of basal and bolus insulin. OBJECTIVE To evaluate efficacy and safety of IDegAsp in pediatric patients with type 1 diabetes (T1D). SUBJECTS Children and adolescents (aged 1 to

Young adults with type 1 diabetes (T1D) experience poor glycemic control, disengagement in care, and are often lost to the medical system well into their adult years. Diabetes providers need a new approach to working with the population. The goal of this study was to determine whether an innovative shared telemedicine appointment care model (CoYoT1 Clinic [pronounced as "coyote"; Colorado Young Adults with T1D]) for young adults with T1D improves care engagement, satisfaction, and adherence to American Diabetes Association (ADA) guidelines regarding appointment frequency.CoYoT1 Clinic was designed to meet the diabetes care needs of young adults (18-25 years of age) with T1D through home telemedicine. Visits occurred every 3 months over the 1-year study (three times by home telemedicine and one time in-person). Outcomes were compared to patients receiving treatment as usual (control).Compared with controls, CoYoT1 patients attended significantly more clinic visits (P 0.0001) and increased their number of clinic visits from the year before the intervention. Seventy-four percent of CoYoT1 patients were seen four times over the 12-month study period, meeting ADA guidelines, but none in the control group met the ADA recommendation. CoYoT1 patients used diabetes technologies more frequently and reported greater satisfaction with care compared with controls.Delivering diabetes care by home telemedicine increases young adults' adherence to ADA guidelines and usage of diabetes technologies, and improves retention in care when compared to controls. Home telemedicine may keep young adults engaged in their diabetes care during this challenging transition period.

OBJECTIVE To compare races/ethnicities for characteristics, at type 1 diabetes diagnosis and during the first 3 years postdiagnosis, known to influence long-term health outcomes. RESEARCH DESIGN AND METHODS We analyzed 927 Pediatric Diabetes Consortium (PDC) participants RESULTS AA subjects, compared with NHW, at diagnosis, were in a higher age- and sex-adjusted BMI percentile (BMI%), had more advanced pubertal development, and had higher frequency of presentation in diabetic ketoacidosis, largely explained by socioeconomic factors. During the first 3 years, AA subjects were more likely to have hypertension and severe hypoglycemia events; had trajectories with higher hemoglobin A1c, BMI%, insulin doses, and IDAA1c; and were less likely to enter the partial remission period. Hispanics, compared with NHWs, had higher BMI% at diagnosis and over the three subsequent years. During the 3 years postdiagnosis, Hispanics had higher prevalence of dyslipidemia and maintained trajectories of higher insulin doses and IDAA1c. CONCLUSIONS Youth of minority race/ethnicity have increased markers of poor prognosis of type 1 diabetes at diagnosis and 3 years postdiagnosis, possibly contributing to higher risk of long-term diabetes complications compared with NHWs.

Background/Aims: Many adolescents with type 2 diabetes (T2D) have rapid deterioration of glycemic control on metformin monotherapy within 2 years of diagnosis. Methods: Enrollment data from the Pediatric Diabetes Consortium T2D Registry were used to categorize 276 youth with a T2D duration ≥2 years into two groups: (1) participants with HbA1c n = 75) and (2) participants treated with insulin ± metformin (group 2, n = 201). The characteristics of the groups were compared. Results: At enrollment, groups 1 and 2 did not differ in age (16.2 vs. 16.8 years) or BMI percentile (99 vs. 98%); group 2 had higher HbA1c (9.9% [85 mmol/mol] vs. 5.9% [41 mmol/mol], p < 0.001). Lower HbA1c and metformin monotherapy at diagnosis were associated with a greater likelihood of adequate control with metformin alone (p < 0.001). In multivariable analysis, HbA1c at diagnosis (p = 0.001) and diabetes duration (p = 0.009) were associated with adequate control on metformin. The HbA1c trajectory after diagnosis was worse in group 2. Conclusion: Durable metabolic control of T2D with metformin monotherapy is most likely in youth presenting with lower HbA1c and with shorter diabetes duration, independent of age, race-ethnicity, and BMI. Elevated HbA1c levels in those on insulin therapy highlight the importance of early diagnosis and a better understanding of glycemic control barriers.

The purpose of this pilot was to implement an innovative group care model, "Team Clinic", for adolescents with type 1 diabetes and assess patient and provider perspectives. Ninety-one intervention patients and 87 controls were enrolled. Ninety-six percent of intervention adolescents endorsed increased support and perceived connecting with peers as important. The medical providers and staff also provided positive feedback stating Team Clinic allowed more creativity in education and higher quality of care. Team Clinic may be a promising model to engage adolescents and incorporate education and support into clinic visits in a format valued by patients and providers.

Background: T1D care delivery via SMA is associated with increased attendance and satisfaction in adolescents, but the impact of the model on clinical and psychosocial outcomes remains unclear. Objective: Evaluate the efficacy of SMA for improving psychosocial outcomes in adolescents with T1D. Methods: Participants in the prospective Team Clinic study were randomized to attend SMA or individual appointments (usual care). They completed the Children’s Depression Inventory (CDI), Problem Areas in Diabetes (PAID), Diabetes Family Conflict Scale (DFCS), and Diabetes Strengths and Resilience (D-STAR) measures at baseline and after one year. Results: Eighty-six adolescents (51% female; 74% white; 10% Latinx) completed at least one study visit. Team Clinic participants (n = 44) attended more visits than patients in usual care (n = 42; p < 0.0001), and they attended all four study visits more frequently (66%) than those in usual care (33%). Although all adolescents reported nearly equal levels of depressive symptoms, emotional distress, and family conflict associated with diabetes care at baseline, significant differences emerged over the course of the study. Specifically, adolescents in Team Clinic reported reduced levels of conflict with family, while those in usual care reported slightly increased levels of conflict (p=0.03). Team Clinic adolescents also reported reduced depressive symptoms when compared to usual care, including more positive mood (p=0.001), greater self-esteem (p=0.03), improved effectiveness in completing daily tasks (p=0.03), and reduced anhedonia (p=0.04). Team Clinic adolescents also reported improved resilience and reduced emotional distress in diabetes care compared to controls, but these results were only marginally significant. Conclusions: SMA may support adolescents with T1D in reducing familial conflict associated with diabetes care, while providing a decrease in comorbid depressive symptoms. Disclosure J. Raymond: Other Relationship; Self; Insulet Corporation. M.W. Reid: None. C. Berget: Consultant; Self; Insulet Corporation, Medtronic. C.L. Cain: None. B. Anderson: None. G.J. Klingensmith: Consultant; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Takeda Pharmaceutical Company Limited. Research Support; Self; Novo Nordisk Foundation. Stock/Shareholder; Spouse/Partner; Dexcom, Inc. Funding The Leona M. and Harry B. Helmsley Charitable Trust

Background: While consensus guidelines indicate that all youth with T2D should be treated with metformin ± insulin at diagnosis, >10% of patients were treated solely with diet/lifestyle on enrollment in the Pediatric Diabetes Consortium (PDC) T2D Registry. Methods: Clinical data was collected on 1,324 Registry patients (age 6 to Results: Of the 1,324 Registry patients, 163 (12%) were treated with diet/lifestyle alone on enrollment. Of these, 73% of were initially treated with metformin ± insulin at diagnosis. The diet/lifestyle and drug-treated groups did not differ by age, gender, diabetes duration, or BMI (Table). However, mean A1c was lower and the proportion of patients with A1c Conclusion: These data indicate that a substantial proportion of youth with T2D can maintain target A1c levels Disclosure W.V. Tamborlane: Consultant; Self; AstraZeneca, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Medtronic MiniMed, Inc., Novo Nordisk Inc., Sanofi, Takeda Pharmaceutical Company Limited. P. Cheng: None. R.L. Gal: None. L.C. Beaulieu: None. C. Kollman: None. M.A. Van Name: Research Support; Self; Novo Nordisk Inc. E.M. Isganaitis: None. L.D. Mastrandrea: Advisory Panel; Self; Pediatric Diabetes Consortium. Research Support; Self; AstraZeneca, JDRF, Novo Nordisk Inc., Sanofi-Aventis, T1D Exchange. Other Relationship; Self; Novo Nordisk Inc. G.J. Klingensmith: Consultant; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Takeda Pharmaceutical Company Limited. Research Support; Self; Novo Nordisk Foundation. Stock/Shareholder; Spouse/Partner; Dexcom, Inc. Funding Boehringer Ingelheim; Novo Nordisk; Takeda Pharmaceutical Company Limited

Background: Racial differences in diabetes control and cardiovascular disease risk factors have been reported in youth with diabetes, with minority youth having worse glycemic control and comorbidities compared with non-Hispanic white (NHW) peers. Methods: We examined racial differences in comorbidities in youth ( Results: The mean age at presentation was 13.4 ± 2.4 years, and mean BMI Z-score was 2.30 ± 0.45. African-American (AA) and Hispanic (H) youth had higher HbA1c and lower C-peptide at diagnosis compared to NHW, with AA 3 times as likely to present in DKA compared with NHW. Microalbuminuria was present in 11%, hypertension in 34% and dyslipidemia in 42% with no significant differences in these comorbidities among racial groups. Nonalcoholic fatty liver disease (NAFLD) was diagnosed in 9% and 11% of H and NHW, respectively vs. 2% in AA (Table). Conclusion: Minority youth with T2D presented with worse metabolic control compared with NHW, with higher rates of DKA in AA youth. Comorbidities exist in a large percentage of youth with T2D independent of ethnicity, except for NAFLD being less prevalent in AA. Disclosure F. Bacha: Research Support; Self; National Institute of Diabetes and Digestive and Kidney Diseases, Pediatric Diabetes Consortium. Other Relationship; Self; AstraZeneca, Jaeb Center for Health Research. P. Cheng: None. R.L. Gal: None. L.C. Beaulieu: None. C. Kollman: None. A. Adolph: None. I. Jindal: None. A.H. Shoemaker: Advisory Panel; Self; Rhythm Pharmaceuticals, Inc. Research Support; Self; AstraZeneca, GLWL Research Inc., Novo Nordisk Inc., Rhythm Pharmaceuticals, Inc., Soleno Therapeutics. R.M. Wolf: None. G.J. Klingensmith: Consultant; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Takeda Pharmaceutical Company Limited. Research Support; Self; Novo Nordisk Foundation. Stock/Shareholder; Spouse/Partner; Dexcom, Inc. W.V. Tamborlane: Consultant; Self; AstraZeneca, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Medtronic MiniMed, Inc., Novo Nordisk Inc., Sanofi, Takeda Pharmaceutical Company Limited. Funding Boehringer Ingelheim; Novo Nordisk; Takeda Pharmaceutical Company Limited

Background: Youth with T2D experience barriers to obtaining diabetes care. We evaluated whether healthcare utilization (HCU) was associated with glycemic outcomes in youth with T2D. Methods: We evaluated annual HCU in 1,324 T2D PDC youth by diabetes duration up to 13 years post diagnosis. Medical record and self-reported HCU data were collected at enrollment and annually. Frequency of diabetes related inpatient admissions, Emergency Department (ED), urgent care, Diabetes Management (DM), Registered Dietician (RD) visits, and 911 calls were collected. Results: After adjusting for age, gender, diabetes duration, and annual visits, those with ≥1 admission/year, regardless of admission reason, (16%) had a higher A1c vs. those without admission, 8.8 vs. 8.4% (p=0.002). Those with ≥2 DM office visits/year (75%) had lower A1c vs. those with 0-1 visits, 8.4 vs. 8.8% (p=0.001). BMI and A1c did not differ by number of RD visits (p=0.63 and 0.39 respectively); RD visits/year decreased over time. Conclusions: In T2D youth, hospitalizations and Disclosure G.J. Klingensmith: Consultant; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Takeda Pharmaceutical Company Limited. Research Support; Self; Novo Nordisk Foundation. Stock/Shareholder; Spouse/Partner; Dexcom, Inc. P. Cheng: None. R.L. Gal: None. L.C. Beaulieu: None. C. Kollman: None. R.L. Adams: None. T.S. Hannon: Advisory Panel; Self; Eli Lilly and Company. L.M. Looper: None. W.V. Tamborlane: Consultant; Self; AstraZeneca, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Medtronic MiniMed, Inc., Novo Nordisk Inc., Sanofi, Takeda Pharmaceutical Company Limited. Funding Boehringer Ingelheim; Novo Nordisk; Takeda Pharmaceutical Company Limited

Background: Participation in GA via HT is associated with improved attendance, satisfaction, and psychosocial functioning in YA with T1D. The effects of long-term participation are unknown. Objective: Evaluate whether exposure to GA via HT improves psychosocial functioning in YA with T1D receiving care via HT. Methods: Patients in the Colorado Young Adults with T1D (CoYoT1) prospective study of GA via HT self-selected into an initial year-long study phase comparing GA to usual care. Next, 58 new and returning patients were randomized to receive HT with or without GA for one year. Overall, 19 patients were exposed to HT alone for one year (GA0), 29 were exposed to HT with GA for one year (GA1), and 10 were exposed to HT with GA for two years (GA2). They completed the EQ-5D, Diabetes Distress Scale (DDS), Center for Epidemiologic Studies Depression (CES-D), Self-Efficacy in Diabetes (SED), and Self-Management of Type 1 Diabetes in Adolescence (SMOD-A) measures. Results: YA patients were 67% female, 86% white, and 11% Latinx. Regardless of attendance, greater exposure to GA was associated with greater communication and self-efficacy; and reduced pain, depressive symptoms, and distress at study end (See Figure 1). Overall, GA1 and GA2 reported better psychosocial functioning than GA0. Conclusions: Greater exposure to GA via HT may improve psychosocial functioning in YA with T1D. Disclosure D.I. Bisno: None. M.W. Reid: None. C. Berget: Consultant; Self; Insulet Corporation, Medtronic. C.L. Cain: None. G.J. Klingensmith: Consultant; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Takeda Pharmaceutical Company Limited. Research Support; Self; Novo Nordisk Foundation. Stock/Shareholder; Spouse/Partner; Dexcom, Inc. J. Raymond: Other Relationship; Self; Insulet Corporation. Funding The Leona M. and Harry B. Helmsley Charitable Trust

The significant increase in the complexity of diabetes care over the last two decades is associated with a high economic burden (1), with almost one-quarter of adults with diabetes burdened with significant out of pocket expenses (OOPEs) (2). Little is known about the OOPEs for families of adolescents and young adults with type 1 diabetes. We therefore report the diabetes-related OOPEs for these families from the SEARCH for Diabetes in Youth (SEARCH) study and their association with demographic, socioeconomic, clinical, and health care characteristics. A detailed description of the SEARCH study methods has previously been published (3). Participants had a baseline visit shortly after diabetes diagnosis and one or more follow-up visits; this report includes data from a follow-up visit between November 2011 and July 2015, at which time participants’ diabetes duration was >5 years. Participants ≥18 years old or a parent/guardian of participants

Background The rapid emergence of type 2 diabetes (T2D) in the pediatric population has left pediatric endocrinologists with limited artillery in terms of management. While multiple medications are available for adults, Food and Drug Administration (FDA)-approved medications in children are limited to only metformin and insulin. Additional treatment options require randomized controlled trials, yet heretofore several barriers at the participant and institutional level have impeded these studies from proceeding in children and adolescents. Identification of the most challenging obstacles that pediatric endocrinologists experience in participating in industry-sponsored T2D trials may facilitate development of feasible platforms for future studies. Materials and Methods We conducted an anonymous online survey consisting of 31 questions that assessed potential barriers to industry-sponsored clinical trials in pediatric patients with T2D. The survey was sent to members of the Pediatric Endocrine Society (PES), and members conducted the survey between October and November of 2014. As part of the survey, respondents rated the significance of several possible barriers to participation in industry-sponsored T2D studies. Results We received a total of 207 responses from members of PES. Baseline demographics showed that 50% of represented institutions care for 50 or fewer T2D patients age 18 years and younger; 70% of institutions diagnose 20 or fewer new T2D cases per year; and 3 racial groups predominated: African American, Hispanic, and Caucasian. A total of 70% of responders have a research infrastructure to participate in clinical trials, but only half have dedicated research nurses. Protocol restrictions on participant recruitment due to current glycemic control or medication use as well as frequent visit schedules were reported to be major obstacles. In addition, the financial support provided to centers to carry out the studies is insufficient. Conclusions Efforts must be made to ease the burden of research participation on both pediatric T2D patients as well as pediatric endocrinologists

Objective Pediatric patients in Colorado with new onset type 1 diabetes (T1D) presenting with diabetic ketoacidosis (DKA) increased from 29.9% to 46.2% from 1998 to 2012. The purpose of this study was to compare differences between patients with newly diagnosed T1D who presented in DKA with those who did not across three domains: sociodemographic factors, access to medical care, and medical provider factors, aiming to identify potential targets for intervention. Methods Sixty-one patients

Objective To describe the clinical characteristics, treatment approaches, clinical outcomes, and co-morbidities of youth with type 2 diabetes (T2D) enrolled in the Pediatric Diabetes Consortium (PDC) T2D Registry. Methods PDC enrolled 598 youth

The economic issues related to medical treatments in youth with type 2 diabetes (T2D) are rarely reported and thus not fully understood. The Treatment Options for type 2 Diabetes in Adolescents and Youth clinical trial of youth recently diagnosed with T2D collected healthcare and related cost information from the largest cohort studied to date. Costs related to medical treatments and expenses faced by caregivers were identified over a 2-year period from 496 participants. Data were collected by surveys and diaries to document frequency of use of diabetes care (excluding study laboratory tests), non-diabetes care services and treatments, caregiver time, and expenses related to exercise and dietary activities recommended for patients. Economic costs were derived by applying national cost values to the reported utilization frequency data. Annual medical costs in the first year varied by the treatment group, averaging $1798 in those assigned to metformin alone (M), $2971 to combination drug therapy with metformin + rosiglitazone (M + R), and $2092 to metformin + an intensive lifestyle and behavior change program (M + L). Differences were primarily due to costs related to combination drug therapy. Adult caregiver support costs were higher for participants in the lifestyle program, which was delivered in weekly sessions in the first 6 months. Expenses for purchases to enhance diet and exercise change did not vary by treatment assignment. In year 2, medication costs increased in M and M + L due to the initiation of insulin in subjects who failed to maintain glycemic control on the assigned treatment. Data are reported for use by researchers and those providing healthcare to this vulnerable patient population.

BACKGROUND/OBJECTIVE Latino patients with type 1 diabetes (T1D) face cultural and language barriers leading to poor outcomes. Shared medical appointments (SMAs) are recognized as effective models of care. Our aim is to develop a culturally sensitive, cost effective SMA program for Latino T1D. SUBJECTS Spanish speaking Latinos 1 to 20 years with T1D (n = 88) and their families. METHODS Routine care alternating with SMAs that included group education was provided. Teens, ages >11 received the SMA separate from parents. Younger children were seen together. Hemoglobin A1c (HbA1c), behavioral questionnaires, and use of diabetes technology were measured at baseline and every 3 to 6 months. RESULTS 57.7% of children and 77.27% of teens completed the 2 years of the Program. There was a significant association between age and change in HbA1c from baseline to year 1 (P = .001) and baseline to year 2 (P =

The American Diabetes Association (ADA) recommends routine diabetes education and interaction with all members of the diabetes team, including diabetes nurse educators, dietitians, and mental health professionals, for pediatric patients with type 1 diabetes (1). The ADA also specifies that education and support for youth with type 1 diabetes should include families/caregivers. However, there is uncertainty in how to address these needs efficiently, effectively, and satisfactorily. Studies have confirmed difficulty incorporating behavioral specialists into diabetes care, with ∼30% of diabetes teams reporting no access to mental health professionals (2). Even centers with access to mental health providers struggle to efficiently incorporate them into routine care. Additionally, despite advances in diabetes management, A1C values increase during adolescence, and poor glycemic control begins earlier (in pre-adolescence) and lasts longer (until patients approach 30 years of age) than previously expected (3). Shared medical appointments, also known as group appointments, were initially designed to meet increasing demands on provider time and improve patient access to care. These appointments have also been found to successfully increase patient and provider satisfaction, strengthen follow-up rates, and improve outcomes in multiple patient populations (4–6). Shared medical appointments have been cited as an effective tool for empowering patients and have been recommended as a successful method for providing more patient-focused care (7). These findings have resulted in an expansion of shared medical appointments into the care of children and adolescents with type 1 diabetes, with positive findings (8–12). When considering the adolescent population with type 1 diabetes, increasing peer support has been suggested as an avenue to improve mental health and adherence with diabetes self-care (13–15), and group visits may be an efficient way to incorporate peer support into routine medical care while also meeting the goal of patients routinely seeing all …

Background Historically, data on the rate of hyperglycemia and ketosis have not been collected in clinical trials. However, it is clinically important to assess the rate of these events in children with type 1 diabetes (T1D). This question was addressed in two pediatric trials using insulin degludec (degludec). Objective To assess the rate of hyperglycemia and ketosis in two-phase 3b trials investigating degludec (Study 1) and degludec with insulin aspart (IDegAsp [Study 2]) vs insulin detemir (IDet). Subjects Patients (aged 1-17 years inclusive) with T1D treated with insulin for ≥3 months. Methods Study 1: patients were randomized to degludec once daily (OD) or IDet OD/twice daily (BID) for 26 weeks, followed by a 26-week extension phase. Study 2: patients were randomized to IDegAsp OD or IDet OD/BID for 16 weeks. Bolus mealtime IAsp was included in both studies. In Study 1, hyperglycemia was recorded if plasma glucose (PG) was >11.1 mmol/L, with ketone measurement required with significant hyperglycemia (>14.0 mmol/L). In Study 2, hyperglycemia was recorded with PG >14.0 mmol/L where the subject looked/felt ill, with ketone measurement also required in these hyperglycemic patients. In this post hoc analysis, the hyperglycemia threshold was 14.0 mmol/L for uniformity. Results Despite similar rates of hyperglycemia with degludec/IDegAsp compared with IDet, the rates of ketosis were lower with degludec/IDegAsp. Conclusions These trials, the first to systematically collect data on ketosis in pediatric patients with T1D, demonstrate the potential of degludec/IDegAsp to reduce rates of metabolic decompensation, compared with IDet.

Background: Treatment options for youth with type 2 diabetes (T2D) are limited compared to those for adults with T2D. As pediatric clinical trials in T2D are difficult to complete, due to lower prevalence and population related recruitment challenges, clinical sites are often reluctant to participate. Protocol design, often not appropriate for pediatrics, administrative and financial burden related to study participation further reduce site interest. Methods: The Pediatric Diabetes Consortium (PDC) is a network of 49 U.S. diabetes centers working together to improve care for children with diabetes. Recognizing challenges associated with pediatric T2D clinical trial participation, the PDC developed a network model to improve efficiency for both sites and sponsors. Innovations: A consulting group was formed to assist with protocol design appropriate for T2D pediatric studies. A PDC master agreement with sites eliminates need for negotiation of standard contract language between sponsor and each site, allowing for a single contract between the PDC and sponsor. A single budget, based upon a clinical trial budget template, reflecting actual site costs, is negotiated by the PDC for all sites. Central archiving of site metrics eliminates need for a feasibility survey before site selection occurs. Monthly site calls led by an investigator oversight committee provide opportunities to discuss enrollment strategies, study challenges and best practices, and provide real-time feedback to sponsor. Conclusion: Efficiencies established by the PDC network model reduce workload for sites and start-up timeline for sponsors. Population-appropriate trial design improves recruitment opportunities. Ongoing site engagement helps to identify and mitigate protocol issues in real-time. The network model improves likelihood of successful trial operations. To date, 26 PDC sites have participated in at least 1 of 3 studies, enrolling 137 across studies so far, contributing to successful recruitment ahead of projected schedule. Disclosure R.L. Gal: Research Support; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Takeda Development Center Americas, Inc., Novo Nordisk Inc. L.C. Beaulieu: Research Support; Self; Novo Nordisk Inc., Boehringer Ingelheim Pharmaceuticals, Inc., Takeda Development Center Americas, Inc.. K.D. Keelin: None. J.E. Less: None. B.A. Nelson: Speaker's Bureau; Self; Dexcom, Inc.. K.A. Wintergerst: None. G.J. Klingensmith: Research Support; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Novo Nordisk Foundation. W.V. Tamborlane: Consultant; Self; AstraZeneca, Boehringer Ingelheim GmbH, Eli Lilly and Company, Medtronic MiniMed, Inc., Novo Nordisk Inc., Sanofi, Takeda Pharmaceuticals U.S.A., Inc..

Objective: To describe the characteristics of youth diagnosed with T2D who have tested positive for ≥1 islet autoantibody (IA) and to examine the persistence of IA over time. Methods: Youth enrolled in the PDC T2D Registry with ≥2 years follow-up after diagnosis and ≥1 positive IA at any time were identified. T2D was determined using ADA guidelines. IAs were measured at each PDC site according to local practice and included IAA, GADA, IA-2A, ZnT8A, and ICA. Positive IAA tests were excluded if measured after insulin initiation. Clinical characteristics, clinical presentation, and treatment over time were analyzed. Results: Positive IA is an exclusion for enrollment in the PDC T2D Registry; however, on review of the ∼1,300 youth in the PDC, 38 were found to have IA. A single IA was found in 35 and >1 IA in 3 participants. GADA was most common (N=32); 3 were persistently positive, 13 converted to negative, 8 became positive after a negative GADA, and 8 had only 1 IA determination. Positive IAA (N=5), IA-2A (N=4) and ZnT8 (N=1) were uncommon or rare, no positive ICA were found. At diagnosis, those IA positive were more likely to be treated with insulin (95% vs. 73%) but with similar HbA1c (10.4% vs. 10.0%). At last visit, those IA positive had longer diabetes duration (5.7 years. vs. 4.8 years.) and higher insulin use (71% vs. 59%) compared to the IA negative cohort, but HbA1c levels were similar (8.7% vs. 9.0%). Age at diagnosis, race/ethnicity, percent male, and BMI were not different between those with and without IA. Conclusion: Most IA positive youth with a T2D phenotype require insulin at diagnosis and more IA positive than IA negative youth require insulin during follow-up treatment. These findings suggest the importance of IA ascertainment at diagnosis and in those failing oral therapy. In T2D youth GADA is the most common IA; yield from ZnT8 and ICA determinations is low; fluctuations in IA positivity are not uncommon. Additional study of youth with T2D phenotype and IA is needed. Disclosure G.J. Klingensmith: Research Support; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Novo Nordisk Foundation. P. Cheng: None. R.L. Gal: Research Support; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Takeda Development Center Americas, Inc., Novo Nordisk Inc. L.C. Beaulieu: Research Support; Self; Novo Nordisk Inc., Boehringer Ingelheim Pharmaceuticals, Inc., Takeda Development Center Americas, Inc. W.V. Tamborlane: Consultant; Self; AstraZeneca, Boehringer Ingelheim GmbH, Eli Lilly and Company, Medtronic MiniMed, Inc., Novo Nordisk Inc., Sanofi, Takeda Pharmaceuticals U.S.A., Inc. F. Bacha: Research Support; Self; AstraZeneca, JAEB Center For Health Research, National Institutes of Health, Pediatric Diabetes Consortium. M.M. Kelsey: Other Relationship; Self; Daiichi Sankyo Company, Limited, Merck Sharp & Dohme Corp. C. Kollman: Research Support; Self; JDRF, Bigfoot Biomedical, Dexcom, Inc., Tandem Diabetes Care, Inc., Medtronic MiniMed, Inc., Helmsley Charitable Trust.

Objective: Hispanic patients with type 1 diabetes (T1D) face cultural and language barriers in care that contribute to a high A1c, infrequent use of diabetes technology and risk of complications. Culturally sensitive programs and shared medical appointments (SMAs) have been recognized as effective models of care. Our aim is to develop a culturally sensitive, cost effective SMA model for pediatric Hispanic T1D patients. Methods: Hispanic patients, ages 1-20, with T1D (n= 88), and their families were recruited to participate in the SMAs. They received routine care appointments alternating with SMAs that included group diabetes education. Teens, ages 12 to 18 attended a separate educational session from parents. Younger children and parents were seen together. A1c, behavioral tools, and use of diabetes technology were measured at baseline and every 3 months for two years. Satisfaction questionnaires were obtained. Results: 62% of young children and 48% of teens completed the first 2 years of the SMA model of care. Results showed that there was a significant association between age and change in A1c for SMA participants from baseline to year 1 (p =.001) and baseline to year 2 (p = 11 years of age (10% to 18% p = .083). Participants had a 90% satisfaction rate. Conclusions: The culturally sensitive SMA proved to be an appreciated, feasible and effective alternative to care for Hispanics with T1D. It may prove to be cost-effective and more effective over the long-term if begun shortly after diagnosis. Disclosure A. Gerard Gonzalez: None. A. Brady: None. G.J. Klingensmith: Research Support; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Novo Nordisk Foundation. L. Pyle: None. J. Thurston: None.

Restrictive eligibility criteria have hampered enrollment into trials for new drugs for youth with type 2 diabetes (T2D). We utilized Pediatric Diabetes Consortium (PDC) T2D Registry enrollment data to estimate the percentage of patients who would be excluded from current T2D trials based on out-of-range HbA1c levels. We also examined whether well-controlled patients could be included because baseline HbA1c would rise during a 6 to 12-month study if assigned to control group.Clinical characteristics and HbA1c levels were collected from 956 T2D patients aged 10 to18 years upon Registry enrollment. HbA1c levels were also analyzed in 6-month intervals during the first 30 months of T2D duration.There was an approximately 2:1 ratio of females to males; the majority were obese and from economically disadvantaged minority families. On enrollment in the Registry, 53% of patients would be excluded from current trials because HbA1c levels were either6.5% (48 mmol/mol) (37%) or10.5% (91 mmol/mol) (16%). Furthermore, in patients with HbA1c levels6.5% (48 mmol/mol) and T2D duration between 6 and 30 months, mean HbA1c levels increased by 0.6% (6 mmol/mol) and 0.9% (10 mmol/mol) over the subsequent 6 and 12 months, respectively.Eligibility criteria for current clinical trials still exclude a large proportion of pediatric T2D patients because of HbA1c levels. Including patients with HbA1c6.5% (48 mmol/mol) would enhance recruitment and allow comparisons of the investigational treatment with placebo-assigned subjects in whom HbA1c levels would on average increase during the 6 to 12 months of the trial.

The Best Pharmaceuticals for Children Act of 2002 mandated that the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) carries out critical reviews of the gaps in knowledge and unmet needs regarding safe and effective pharmacologic treatment of infants, children, and adolescents in a broad range of disease areas. In 2012, NICHD selected diabetes mellitus as one of the pediatric disorders for review. Dr. William V. Tamborlane was named chair, and Dr. Linda DiMeglio, vice-chair, of the Diabetes Working Group. Together with Dr. George Giacoia of NICHD, they assembled a distinguished group of medical experts in childhood diabetes, including clinicians/clinical investigators from leading academic centers and from industry and representatives from the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), to carry out this review. It is very important to note that the views expressed in this article, as well as in other reports from the Diabetes Working Group, are the personal views of the authors and may not be understood or quoted as being made on behalf of or reflecting the position of the FDA or EMA or any of the organizations or pharmaceutical companies represented in our working group. As shown in Supplementary Table 1, the large Diabetes Working Group was divided into five committees: Type 1 Diabetes (T1D): Therapeutics, Type 2 Diabetes (T2D): Therapeutics, T1D: Natural History and Biomarkers, T2D: Natural History and Biomarkers, and Diabetes Pharmacology. The consensus of the T2D Therapeutics Committee was that its efforts should address the crisis in care that clinicians face in treating this disorder in adolescents. Despite a plethora of new drug classes and new agents within each class that have been approved for use in adults with T2D, in …

OBJECTIVE We evaluated pregnancy outcomes, maternal and fetal/neonatal, during the Treatment Options for type 2 Diabetes in Adolescents and Youth (TODAY) study. RESEARCH DESIGN AND METHODS The TODAY study was a randomized controlled trial comparing three treatment options for youth with type 2 diabetes. Informed consent included the requirement for contraception, including abstinence; this was reinforced at each visit. Following informed consent, self-reported data related to the mother’s prenatal care and delivery and the infant’s health were retrospectively collected. When permitted, maternal medical records and infant birth records were reviewed. RESULTS Of the 452 enrolled female participants, 46 (10.2%) had 63 pregnancies. Despite continued emphasis on adequate contraception, only 4.8% of the pregnant participants reported using contraception prior to pregnancy. The mean age at first pregnancy was 18.4 years; the mean diabetes duration was 3.17 years. Seven pregnancies were electively terminated; three pregnancies had no data reported. Of the remaining 53 pregnancies, 5 (9.4%) resulted in early pregnancy loss, and 7 (13%) resulted in loss with inadequate pregnancy duration data. Two pregnancies ended in stillbirth, at 27 and 37 weeks, and 39 ended with a live-born infant. Of the live-born infants, six (15.4%) were preterm and eight (20.5%) had a major congenital anomaly. CONCLUSIONS Despite diabetes-specific information recommending birth control and the avoidance of pregnancy, 10% of the study participants became pregnant. Pregnancies in youth with type 2 diabetes may be especially prone to result in congenital anomalies. Reasons for the high rate of congenital anomalies are uncertain, but may include poor metabolic control and extreme obesity.

Objective To describe vitamin D levels and prevalence of vitamin D sufficiency, insufficiency and deficiency in a large, ethnically/racially diverse population of youth with type 1 diabetes (T1D) and type 2 diabetes (T2D) in comparison to national data and examine the associations between clinical/demographic factors and vitamin D levels. Methods 25-hydroxy vitamin D (25OHD) levels were measured in 215 youth with T1D and 326 youth with T2D enrolled in the Pediatric Diabetes Consortium (PDC). These levels were compared with those of youth of the same age without diabetes from the 2005–2006 NHANES Survey. Results Vitamin D deficiency (

Objective Type 2 diabetes (T2D) in youth is recognized as a pediatric disease, but few reports describe the characteristics during diagnosis. We describe the clinical presentation of 503 youth with T2D. Methods The Pediatric Diabetes Consortium (PDC) T2D Clinic Registry enrolled T2D participants from eight pediatric diabetes centers in the USA. Clinical and laboratory characteristics at the time of diagnosis were analyzed. Results In total 67% presented with symptoms of diabetes and confirming laboratory data, but 33% were identified by testing at risk children, 11% presented with diabetic ketoacidosis (DKA), and 2% with hyperglycemic hyperosmolar state (HHS). The mean age was 13.1 ± 2.3 yr (range, 4.6–19.8 yr) with 38 (8%) less than 10 yr of age at diagnosis. The majority was female (65%), Hispanic (54%) and had a family history of T2D (92%). The median body mass index (BMI) z-score was 2.3 (interquartile range 2.0–2.6). Fewer than half (46%) lived with both parents, only 30% had parents with education beyond high school, and 43% lived in a household with an income of

Objective To describe C-peptide levels in a large cohort of children with type 2 diabetes T2D and examine associations with demographic and clinical factors. Methods The Pediatric Diabetes Consortium (PDC) T2D Registry has collected clinical and biologic data from youth with T2D cared for at eight US Pediatric Diabetes Centers. In this study, we assessed C-peptide levels in 331 youth with T2D (mean age, 16.1 ± 2.5 yr; median T2D duration, 2.4 yr). Results Median (interquartile range) for 90 fasted C-peptide measurements was 3.5 ng/mL (2.3–4.8 ng/mL) [1.2 nmol/L (0.8–1.6 nmol/L)] and for 241 random non-fasted C-peptide measurements were 4.2 ng/mL (2.6–7.0 ng/mL) [1.4 nmol/L (0.9–2.3 nmol/L)]. C-peptide levels were lower with insulin therapy (p

Maturity-onset diabetes of the young (MODY) is an antibody-negative, autosomal dominant form of diabetes. With the increasing prevalence of diabetes and the expense of MODY testing, markers to identify those who need further genetic testing would be beneficial. We investigated whether HLA genotypes, random C-peptide, and/or high-sensitivity C-reactive protein (hsCRP) levels could be helpful biomarkers for identifying MODY in antibody-negative diabetes.Subjects (N = 97) with diabetes onset ≤age 25, measurable C-peptide (≥0.1 ng/mL), and negative for all four diabetes autoantibodies were enrolled at a large academic center and tested for MODY 1-5 through Athena Diagnostics. A total of 22 subjects had a positive or very likely pathogenic mutation for MODY.Random C-peptide levels were significantly different between MODY-positive and MODY-negative subjects (0.16 nmol/L vs. 0.02 nmol/L; P = 0.02). After adjusting for age and diabetes duration, hsCRP levels were significantly lower in MODY-positive subjects (0.37 mg/L vs. 0.87 mg/L; P = 0.02). Random C-peptide level ≥0.15 nmol/L obtained at ≥6 months after diagnosis had 83% sensitivity for diagnosis of MODY with a negative predictive value of 96%. Receiver operating characteristic curves showed that area under the curve for random C-peptide (0.75) was significantly better than hsCRP (0.54), high-risk HLA DR3/4-DQB1*0302 (0.59), and high-risk HLA/random C-peptide combined (0.54; P = 0.03).Random C-peptide obtained at ≥6 months after diagnosis can be a useful biomarker to identify antibody-negative individuals who need further genetic testing for MODY, whereas hsCRP and HLA do not appear to improve this antibody/C-peptide-based approach.

To examine and compare the clinical characteristics and treatment of youth with type 2 diabetes (T2D) in two registries: one in Europe and one in the United States.Youth with onset of T2D at 10 to 18 years of age with current age20 years and an office visit after diabetes duration1 year were identified in the European (Prospective Diabetes Follow-up, DPV) and the United States (Pediatric Diabetes Consortium, PDC) databases. Demographic, physical and clinical characteristics and treatment at diagnosis as well as physical characteristics, treatment, laboratory data, and diabetes adverse events at most recent visit were analyzed from both registries.At diagnosis, the majority were female and obese; 70% of DPV vs 34% of PDC youth were diagnosed by targeted diabetes testing. PDC youth were younger, 12 vs 13 years (P 0.001), had a greater body mass index-SDS, 3.07 vs 2.74 (P 0.001), a higher hemoglobin A1c (HbA1c), 9.9% vs 7.1% (P 0.001), were more likely to present in DKA, 7.5% vs 1.3% (P 0.001) and more likely to be treated with insulin, 62% vs 32% (P 0.001); insulin treatment difference was not significant when adjusted for HbA1c. At follow-up, DPV youth had shorter diabetes duration, 2.1 vs 3.2 years (P 0.001), lower HbA1c, 6.5% vs 7.8% (P 0.001), were less likely to be treated with insulin, 36% vs 56%, (P 0.001), and were more likely to have dyslipidemia and hypertension than PDC youth. PDC youth had a higher rate of microalbuminuria.Both DPV and PDC youth have multiple risks for diabetes complications. Understanding reasons for persistently higher HbA1c in PDC youth requires further study.

The SEARCH for Diabetes in Youth Study prospectively identified youth aged

Objective To describe parent perceptions of children's diabetes care at school including: availability of licensed health professionals; staff training; logistics of provision of care; and occurrence and treatment of hypo- and hyperglycemia; and to examine parents' perceptions of their children's safety and satisfaction in the school environment. Research design and methods A survey was completed by parents of children with type 1 diabetes from permissive (trained, non-medical school personnel permitted to provide diabetes care; N = 237) and non-permissive (only licensed health care professionals permitted to provide diabetes care; N = 198) states. Results Most parents reported that schools had nurses available for the school day; teachers and coaches should be trained; nurses, children, and parents frequently provided diabetes care; and hypo- and hyperglycemia occurred often. Parents in permissive states perceived children to be as safe and were as satisfied with care as parents in non-permissive states. Conclusions Training non-medical staff will probably maximize safety of children with diabetes when a school nurse is not available.

Olga Kordonouria, Georgeanna Klingensmithb, Mikael Knipc, Reinhard W Holld, Henk-Jan Aanstoote, Puthezhath SN Menonf and Maria E Craigg,h,i aDiabetes Centre for Children and Adolescents, Children’s Hospital auf der Bult, Hannover, Germany; bDepartment of Pediatrics, The Children’s Hospital and Barbara Davis Centre, University of Colorado, Aurora, CO, USA; cHospital for Children and Adolescents, University of Helsinki, Helsinki, Finland; dInstitute of Epidemiology and Medical Biometry, University of Ulm, Ulm, Germany; eDiabeter Center for Pediatric and Adolescent Diabetes Care and Research, Rotterdam, the Netherlands; fDepartment of Pediatrics, Jaber Al-Ahmed Armed Forces Hospital, Kuwait, Kuwait; gInstitute of Endocrinology and Diabetes, The Children’s Hospital at Westmead, Sydney, Australia; hDiscipline of Pediatrics and Child Health, University of Sydney, Sydney, Australia and iSchool of Women’s and Children’s Health, University of New South Wales, Sydney, Australia

Background Insulin resistance increases during adolescence in those with type 1 diabetes (T1DM), complicating glycemic control and potentially increasing cardiovascular disease (CVD) risk. Metformin, typically used in type 2 diabetes (T2DM), is a possible adjunct therapy in T1DM to help improve glycemic control and insulin sensitivity.

We thank Dr. Nwosu for his thoughtful comments (1). We agree that insulin resistance influences insulin dose–adjusted hemoglobin A1c (IDAA1c). Nagl et al. (2) observed that the partial remission period was less frequent and shorter in girls than boys, but, without C-peptide measurements, the authors could only speculate that higher insulin resistance or lower insulin secretion might explain their findings. However, we found that, adjusting for BMI, age, and sex, insulin doses were still different between African Americans (AAs) and non-Hispanic whites (NHWs) ( P < 0.001) (3), suggesting that after controlling for factors that increase insulin resistance there was still a difference in insulin dose, and thus in IDAA1c. Other measures of partial remission period, e.g., insulin dose, are also affected by insulin resistance. Furthermore, although defining partial remission period based on …

Objective There have been few prospective, multicenter studies investigating the natural history of type 1 diabetes (T1D) from the time of diagnosis. The objective of this report from the Pediatric Diabetes Consortium (PDC) T1D New Onset (NeOn) study was to assess the natural history and clinical outcomes in children during the first year after diagnosis of T1D.

Objective To identify determinants of HbA1c levels one year after the diagnosis of type 1 diabetes (T1D) in participants in the Pediatric Diabetes Consortium (PDC) T1D New Onset (NeOn) Study.

Background/Aims: Youth with type 2 diabetes (T2D) have poor compliance with medical care. This study aimed to determine which demographic and clinical factors differ between youth with T2D who receive care in a pediatric diabetes center versus youth lost to follow-up for >18 months. Methods: Data were analyzed from 496 subjects in the Pe­diatric Diabetes Consortium registry. Enrollment variables were selected a priori and analyzed with univariable and multivariable logistic regression models. Results: After a median of 1.3 years from enrollment, 55% of patients were lost to follow-up. The final model included age, race/ethnicity, parent education, and estimated distance to study site. The odds ratio (99% confidence interval) of loss to follow-up was 2.87 (1.34, 6.16) for those aged 15 to Conclusion: Older adolescents with T2D are more likely to be lost to follow-up, but other socioeconomic factors were not significant predictors of clinic follow-up.

Background Youth with type 1 diabetes do not count carbohydrates accurately, yet it is an important strategy in blood glucose control. Objective The study objective was to determine whether a nutrition education intervention would improve carbohydrate counting accuracy and glycemic control. Design We conducted a randomized, controlled nutrition intervention trial that was recruited from February 2009 to February 2010. Subjects Youth (12 to 18 years of age, n=101) with type 1 diabetes were screened to identify those with poor carbohydrate counting accuracy, using a previously developed carbohydrate counting accuracy test covering commonly consumed foods and beverage items presented in six mixed meals and two snacks. All participants (n=66, age=15±3 years, 41 male, diabetes duration=6±4 years, hemoglobin A1c [HbA1c]=8.3%±1.1%) were randomized to the control or intervention group at the baseline visit. The intervention group attended a 90-minute class with a registered dietitian/certified diabetes educator and twice kept 3-day food records, which were used to review carbohydrate counting progress. Main outcome measures Carbohydrate counting accuracy (measured as described) and HbA1c were evaluated at baseline and 3 months to determine the effectiveness of the intervention. Statistical analyses performed t Tests, Spearman correlations, and repeated measures models were used. Results At baseline, carbohydrate content was over- and underestimated in 16 and 5 of 29 food items, respectively. When foods were presented as mixed meals, participants either significantly over- or underestimated 10 of the 9 meals and 4 snacks. After 3 months of follow-up, HbA1c decreased in both the intervention and control groups by −0.19%±0.12% ( P =0.12) and −0.08%±0.11% ( P =0.51), respectively; however, the overall intervention effect was not statistically significant for change in HbA1c or carbohydrate counting accuracy. Conclusions More intensive intervention might be required to improve adolescents' carbohydrate counting accuracy and nutrition management of type 1 diabetes. Additional research is needed to translate nutrition education into improved health outcomes.

Objective To evaluate UBASH3A (rs11203203) as a predictor of persistent islet autoimmunity (IA) and type 1 diabetes (T1D). Research design and methods The Diabetes Autoimmunity Study in the Young (DAISY) followed prospectively for development of persistent IA (autoantibodies to insulin, GAD65, IA-2, or ZnT8 on at least two consecutive exams) and diabetes 1715 non-Hispanic white children at increased genetic risk for T1D. The DAISY participants were genotyped for rs11202203 (UBASH3A). Results UBASH3A allele A was associated with development of IA [hazard ratio (HR) = 1.46, 95%CI = 1.11–1.91, p = 0.007] and diabetes (HR = 1.84, 95%CI = 1.28–2.64, p = 0.001), controlling for presence of HLA-DR3/4,DQB1*0302 and having a first-degree relative (FDR) with T1D. The UBASH3A AA genotype conferred higher risk of persistent IA (12.7%) and diabetes (6.1%) by age 10 than for AG (7.7 and 3.1%, respectively) or GG (5.3 and 2.0%) genotype (p = 0.009 for IA, p = 0.0004 for diabetes). Among children with no family history of T1D, but HLA-DR3/4,DQB1*0302 and UBASH3A AA genotype, 35.9% developed IA and 50.6% developed diabetes by age 15. Conclusions UBASH3A appears to be an independent predictor of IA and T1D in children, including those free of family history of T1D but carrying the HLA-DR3/4,DQB1*0302 genotype. If confirmed, UBASH3A may prove useful in T1D risk prediction and pre-screening of the general population children for clinical trials.