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Background: The purpose of this study was to collect 1 year of real-world data from individuals with type 1 diabetes (T1D) initiating the Medtronic 670G hybrid closed-loop insulin delivery system a...

Context Continuous glucose monitoring (CGM) is increasingly being used both for day-to-day management in patients with diabetes and in clinical research. While data on glycemic profiles of healthy, nondiabetic individuals exist, data on nondiabetic very young children are lacking. Objective This work aimed to establish reference sensor glucose ranges in healthy, nondiabetic young children, using a current-generation CGM sensor. Methods This prospective observational study took place in an institutional practice with healthy, nondiabetic children aged 1 to 6 years with normal body mass index. A blinded Dexcom G6 Pro CGM was worn for approximately 10 days by each participant. Main outcome measures included CGM metrics of mean glucose, hyperglycemia, hypoglycemia, and glycemic variability. Results Thirty-nine participants were included in the analyses. Mean average glucose was 103 mg/dL (5.7 mmol/L). Median percentage time between 70 and 140 mg/dL (3.9-7.8 mmol/L) was 96% (interquartile range, 92%-97%), mean within-individual coefficient of variation was 17 ± 3%, median time spent with glucose levels greater than 140 mg/dL was 3.4% (49 min/day), and median time less than 70 mg/dL (3.9 mmol/L) was 0.4% (6 min/day). Conclusion Collecting normative sensor glucose data and describing glycemic measures for young children fill an important informational gap and will be useful as a benchmark for future clinical studies.

OBJECTIVE Impaired awareness of hypoglycemia (IAH) and recurrent severe hypoglycemia (RSH) remain problematic for people with type 1 diabetes (T1D), despite major therapeutic advances. We explored beliefs around hypo- and hyperglycemia in adults with T1D with, and without, IAH and RSH. RESEARCH DESIGN AND METHODS A cross-sectional U.S. multicenter survey included Attitudes to Awareness of Hypoglycemia (A2A; a 19-item questionnaire concerning beliefs about hypoglycemia), the Gold score (single item: awareness of hypoglycemia), and a question about severe hypoglycemia over the preceding year. The survey was emailed to 6,200 adult participants of the annual T1D Exchange clinic registry data collection. A2A data were subjected to principal component analysis with varimax rotation. RESULTS Among 1,978 respondents (response rate 32%), 61.7% were women, mean ± SD age was 39.6 ± 16.3 years, and T1D duration was 23.1 ± 13.8 years. Thirty-seven percent reported IAH, 16% RSH, and 9% both. A2A items segregated into three factors, differently distributed by hypoglycemia experience. Respondents with IAH or RSH expressed appropriate concern about hypoglycemia, but those with IAH were more likely to prioritize hyperglycemia concerns than those with intact awareness (P = 0.002). Those with RSH showed greater normalization of asymptomatic hypoglycemia than those without (P = 0.019) and trended toward prioritizing hyperglycemia concerns (P = 0.097), driven by those with both IAH and RSH. CONCLUSIONS Adults with T1D with IAH and RSH report specific cognitions about hypoglycemia and hyperglycemia, which may act as barriers to hypoglycemia avoidance and recovery of awareness. These may be modifiable and present a target for enhancing engagement of vulnerable people with strategies to avoid future hypoglycemia.

Context Use of continuous glucose monitoring (CGM) is increasing for insulin-requiring patients with diabetes. Although data on glycemic profiles of healthy, nondiabetic individuals exist for older sensors, assessment of glycemic metrics with new-generation CGM devices is lacking. Objective To establish reference sensor glucose ranges in healthy, nondiabetic individuals across different age groups using a current generation CGM sensor. Design Multicenter, prospective study. Setting Twelve centers within the T1D Exchange Clinic Network. Patients or Participants Nonpregnant, healthy, nondiabetic children and adults (age ≥6 years) with nonobese body mass index. Intervention Each participant wore a blinded Dexcom G6 CGM, with once-daily calibration, for up to 10 days. Main Outcome Measures CGM metrics of mean glucose, hyperglycemia, hypoglycemia, and glycemic variability. Results A total of 153 participants (age 7 to 80 years) were included in the analyses. Mean average glucose was 98 to 99 mg/dL (5.4 to 5.5 mmol/L) for all age groups except those over 60 years, in whom mean average glucose was 104 mg/dL (5.8 mmol/L). The median time between 70 to 140 mg/dL (3.9 to 7.8 mmol/L) was 96% (interquartile range, 93 to 98). Mean within-individual coefficient of variation was 17 ± 3%. Median time spent with glucose levels >140 mg/dL was 2.1% (30 min/d), and median time spent with glucose levels Conclusion By assessing across age groups in a healthy, nondiabetic population, normative sensor glucose data have been derived and will be useful as a benchmark for future research studies.

This report describes patient-reported data from persons with T1D initiating use of the Medtronic MiniMed 670G HCL insulin delivery system (670G) for clinical care. Questionnaires were completed in clinic before starting the system, and then follow up surveys were emailed at 6 weeks, 6 months and 12 months from the time of enrollment. Participants who completed the 6 week survey (n=97) had a mean HbA1c of 8.2%, T1D duration of 19 yrs, median age of 37 yrs, with 57% being female, 88% non-Hispanic white. Most were on pump therapy at baseline with 87% using a sensor. Nearly all who completed the training questionnaire agreed/strongly agreed that he/she received adequate training on the majority of the 670G components. Alarms were described as somewhat to very bothersome during the day by nearly half of participants/parents and more than half had issues with sleep interruption at night (Table). Close to half (~40%) noted frequent exits from Auto Mode were somewhat to very bothersome. In this real-world assessment of 670G use, while many were satisfied by device training, issues with the system were prevalent amongst those who persisted with device use. With this first in-class device, this study highlights that methods to minimize burdens of HCL use, such as the number of alarms and frequent exits from automation, will be essential for alternate and next generation systems. Disclosure C. Bauza: None. S. Dubose: None. A. Verdejo: None. R. Beck: Consultant; Self; Bigfoot Biomedical, Inc., Diasome Pharmaceuticals, Inc., Insulet Corporation, Lilly Diabetes, vTv Therapeutics, Research Support; Self; Beta Bionics, Inc., Dexcom, Inc., Medtronic, Novo Nordisk, Tandem Diabetes Care. R. M. Bergenstal: Advisory Panel; Self; Abbott Diabetes, Eli Lilly and Company, Novo Nordisk, Onduo LLC., Roche , Sanofi, United Healthcare , Consultant; Self; Abbott Diabetes, Ascensia , Dexcom, Inc., Eli Lilly and Company, Hygieia, Johnson & Johnson, Medtronic, Novo Nordisk, Onduo LLC., Roche, Sanofi, United Healthcare, Other Relationship; Self; HealthPartners Institute, Research Support; Self; Abbott Diabetes, Dexcom, Inc., Eli Lilly and Company, Helmsley Charitable Trust, Hygieia, Johnson & Johnson, Medtronic, NIDDK, Novo Nordisk, Onduo LLC., Roche, Sanofi, United Healthcare. J. Sherr: Advisory Panel; Self; Cecelia Health, Insulet Corporation, Medtronic, Consultant; Self; Insulet Corporation, Lexicon Pharmaceuticals, Inc., Lilly Diabetes, Medtronic, Research Support; Self; Dexcom, Inc., Insulet Corporation, Medtronic, Speaker’s Bureau; Self; Lilly Diabetes. Funding The Leona M. and Harry B. Helmsley Charitable Trust

To assess risk factors and incidence of diabetes complications in women with type 1 diabetes (T1D) based on parity.Data were collected from women (16-40 years old) in the T1D Exchange completing pregnancy/childbirth questionnaires during 2011-2013 and 2016-2018. Incidence of risk factors and diabetes complications were compared between women with a first pregnancy at/within 1-year of enrollment (There was a trend for lower HbA1c (adjustedFour-5 years after delivery, parous women with T1D tended to have lower HbA1c levels despite higher body mass indices and more frequent adverse lipid profiles and hypertension compared with nulliparous women. Further studies based on these trends are warranted.

Objectives: To examine changes in device use and glycemic outcomes for pregnant women from the T1D Exchange Clinic Registry between the years 2010-2013 and 2016-2018. Methods: Participant-reported device use and glycemic outcomes were compared for women aged 16-40 years who were pregnant at the time of survey completion, comparing 2010-2013 (cohort 1) and 2016-2018 (cohort 2). Hemoglobin A1c results within 30 days prior to survey completion were obtained from medical records. Results: There were 208 pregnant women out of 5,236 eligible participants completing the questionnaire in cohort 1 and 47 pregnant women out of 2,818 eligible participants completing the questionaire in cohort 2. Continuous glucose monitor (CGM) use while pregnant trended upward among cohort 2 (70% vs 37%, P = .02), while reported continuous subcutaneous insulin infusion (CSII) use while pregnant declined (76% vs 64%, P = .04). HbA1c levels trended downward (6.8% cohort 1 vs 6.5% cohort 2, P = .07). Conclusions: Self-reported CGM use while pregnant increased over the studied intervals whereas CSII use decreased. Additional evaluation of device use and the potential benefits for T1D pregnancies is needed.

Objective To develop and validate new measures of diabetes-specific health-related quality of life (HRQOL) for people with type 1 diabetes (T1D) that are brief, developmentally appropriate, and usable in clinical research and care. Here we report on the phases of developing and validating the self-report Type 1 Diabetes and Life (T1DAL) measures for children (age 8–11) and adolescents (age 12–17). Methods Measure development included qualitative interviews with youth and parents (n = 16 dyads) followed by piloting draft measures and conducting cognitive debriefing with youth (n = 9) to refine the measures. To evaluate the psychometric properties, children (n = 194) and adolescents (n = 257) at three T1D Exchange Clinic Network sites completed the age-appropriate T1DAL measure and previously validated questionnaires measuring related constructs. Using psychometric data, the investigators reduced the length of each T1DAL measure to 21 and 23 items, respectively, and conducted a final round of cognitive debriefing with six children and adolescents. Results The T1DAL measures for children and adolescents demonstrated good internal consistency (α = 0.84 and 0.89, respectively) and test–retest reliability (r = 0.78 and 0.80, respectively). Significant correlations between the T1DAL scores and measures of general quality of life, generic and diabetes-specific HRQOL, diabetes burden, and diabetes strengths demonstrated construct validity. Correlations with measures of self-management (child and adolescent) and glycemic control (adolescent only) demonstrated criterion validity. Factor analyses indicated four developmentally specific subscales per measure. Participants reported satisfaction with the measures. Conclusions The new T1DAL measures for children and adolescents with T1D are reliable, valid, and suitable for use in care settings and clinical research.

Background Celiac disease (CD) is common in patients with type 1 diabetes (T1D) and effects of CD on growth in children with T1D remain unclear. Methods We analyzed heights, weights, and body mass index (BMI) in 215 matched pediatric CD/control pairs in the T1D Exchange Clinic Registry. CD was defined by a clinic-reported diagnosis and positive celiac serology (n = 80) and/or positive small bowel biopsy (n = 135). Cases and controls were matched by age (mean: 14 years), diabetes duration (median: 7 years), sex (57% female), and clinic site. There were 5569 height/weight measurements. Results Gluten was restricted for varying periods of time in 61% of females and 51% of males with CD. Females with CD were shorter than female controls at all ages (P = 0.01). Weight z-scores were initially lower in preschool females with CD but similar to controls by middle childhood. Males with CD were initially shorter but adult heights were similar. Height in both sexes and weight in males were lower in CD participants diagnosed at younger age. Growth in T1D children with biopsy-proven CD, 76% of them were gluten-restricted, was comparable to that of T1D controls. Conclusion Concurrent CD impairs linear growth in T1D females at all stages of development and in young T1D males. Young females with CD have lower weights, but both sexes have similar weights by middle childhood. Children younger at CD onset remain shorter throughout childhood; males younger at CD onset have persistently lower weights. Long-term gluten restriction may restore weight gain and linear growth in children with CD and T1D.

Context Standard treatment of hypoglycemia is oral carbohydrate, but it often results in hyperglycemia and entails extra caloric intake. Objective To evaluate low-dose glucagon to treat mild hypoglycemia in ambulatory adults with type 1 diabetes (T1D). Design Randomized crossover trial (two 3-week periods). Setting Five U.S. diabetes clinics. Patients Twenty adults with T1D using an insulin pump and continuous glucose monitor (CGM) and experiencing frequent mild hypoglycemia. Intervention Nonaqueous mini-dose glucagon (MDG) (150 µg) to treat nonsevere hypoglycemia. Main outcome measures Successful treatment was defined as blood glucose (BG) ≥50 mg/dL 15 minutes and ≥70 mg/dL 30 minutes after intervention, on the study meter. Two authors, blinded to treatment arm, independently judged each event as a clinical success or failure. Results Sixteen participants (mean age 39 years, 75% female, mean diabetes duration 23 years, mean hemoglobin A1c 7.2%) had 118 analyzable events with initial BG of 50 to 69 mg/dL. Successful treatment criteria were met for 58 (94%) of 62 events during the MDG period and 53 (95%) of 56 events during the glucose tablets (TABS) period (adjusted P = 0.99). Clinical assessments of success for these events were 97% and 96%, respectively. CGM-measured time in range did not differ between treatment groups during the 2 hours after events, but TABS resulted in higher maximum glucose (116 vs 102 mg/dL; P = 0.01) over the first hour. Conclusions Low-dose glucagon can successfully treat mild hypoglycemia and may be a useful alternative to treatment with oral carbohydrate when trying to avoid unnecessary caloric intake.

Objective: The aim of these analyses was to characterize the effect of exercise and meals on glucose concentrations in healthy individuals without diabetes. Methods: Healthy individuals without diabetes (age ≥6 years) with nonobese body mass index were enrolled at 12 centers within the T1D Exchange Clinic Network. Participants wore a blinded Dexcom G6 for up to ten days. Throughout this sensor wear, participants completed a daily log indicating times and type of any exercise and start times of meals and snacks. Results: A total of 153 participants (age 7-80 years) were included in the analyses. Exercise induced a mean change of −15 ± 18 mg/dL from baseline to nadir sensor glucose level. Mean nadir glucose concentration during nights following exercise days was 82 ± 11 mg/dL compared with 85 ± 11 mg/dL during nights following nonexercise days ( P = .05). Mean change from baseline to nadir sensor glucose level during aerobic exercise was −15 ± 18 and −9 ± 12 mg/dL for resistance exercise ( P = .25). Overnight nadir glucose during nights following aerobic and resistance exercise was 83 ± 12 and 76 ± 14 mg/dL, respectively ( P = .25). Overall mean peak postprandial glucose per participant increased from 93 ± 10 mg/dL premeal to 130 ± 13 mg/dL with an average time to peak glucose per participant of 97 ± 31 minutes. Consumption of alcohol on the day prior did not impact overnight mean or nadir glucose. Conclusion: The present analysis provides important data characterizing the effect of exercise and meals on glucose in healthy individuals without diabetes. These data provide a repository to which future therapies, whether pharmacologic or technologic, can be compared.

We aimed to assess the association between pregnancy and occurrence of diabetes-related complications in women with type 1 diabetes (T1D). Females 16-40 years old in the T1D Exchange clinic registry completing an initial questionnaire during 2011-13 and repeating it between 2016-18 (N=497; age 22±5 years, duration 12 [6,17] years, 87% non-Hispanic White) were categorized into 2 cohorts: first pregnancy during 2011-13 (preg; n=28) and never pregnant (never; n=469). No participants had complications reported at baseline. Funduscopic exam data were not uniformly available. There was a trend for lower HbA1c 5 years after study enrollment in the preg group (7.3%±1.3%) compared with the never group (7.9%±1.4%), P=0.14 adjusted for age, race/ethnicity, and body mass index. Both albuminuria and nephropathy within 5 years of study enrollment were found at higher frequency in the women who had never been pregnant (Table). Rates of neuropathy within 5 years of enrollment were similar between the groups. While rates of cardiovascular disease within 5 years of study enrollment were low for both groups (0 in preg group and 2 participants in never group), the pregnant cohort despite having lower A1c had higher frequency of some cardiovascular disease risk factors (e.g., obesity). In persons with T1D without reported complications at enrollment, pregnancy was not associated with new complication development 5 years after delivery. Disclosure S. Polsky: Consultant; Self; Jaeb Center for Health Research. Research Support; Self; Barbara Davis Center for Diabetes, Children's Diabetes Foundation, Dexcom, Inc., Eli Lilly and Company, JDRF, Leona & Harry Helmsley Charitable Trust, National Institute of Diabetes and Digestive and Kidney Diseases, Sanofi US. N.C. Foster: None. S. DuBose: None. S. Agarwal: None. S. Lyons: None. A.L. Peters: Advisory Panel; Self; Abbott, Becton, Dickinson and Company, Bigfoot Biomedical, Eli Lilly and Company, Lexicon Pharmaceuticals, Inc., Livongo Health, MannKind Corporation, Medscape, Merck & Co., Inc., Omada Health, Inc., OptumRx, Inc., Sanofi US, Zafgen, Inc. Research Support; Self; AstraZeneca, Dexcom, Inc., Jaeb Center for Health Research, MannKind Corporation, National Institute of Diabetes and Digestive and Kidney Diseases. Speaker's Bureau; Self; Novo Nordisk Inc. G.I. Uwaifo: None. L. DiMeglio: Research Support; Self; Amgen Inc., Caladrius Biosciences, Inc., Janssen Research & Development, Medtronic, Sanofi. Other Relationship; Self; Dexcom, Inc. J. Sherr: Advisory Panel; Self; Bigfoot Biomedical, Eli Lilly and Company, Insulet Corporation. Consultant; Self; Lexicon Pharmaceuticals, Inc., Medtronic, Sanofi. Research Support; Self; Dexcom, Inc., Insulet Corporation. C.J. Levy: Advisory Panel; Self; Novo Nordisk A/S, Sanofi. Employee; Spouse/Partner; Allergan. Funding The Leona M. and Harry B. Helmsley Charitable Trust

It is a common belief that females experience more hypoglycemia than males. We aimed to assess whether this was true in a cohort of healthy individuals without diabetes. In this multicenter study, healthy, nondiabetic children and adults (age 7 to 80 years, normal BMI, HbA1c Disclosure S. DuBose: None. Z. Li: None. V.N. Shah: Advisory Panel; Self; Sanofi US. Consultant; Self; Dexcom, Inc. J. Sherr: Advisory Panel; Self; Bigfoot Biomedical, Eli Lilly and Company, Insulet Corporation. Consultant; Self; Lexicon Pharmaceuticals, Inc., Medtronic, Sanofi. Research Support; Self; Dexcom, Inc., Insulet Corporation. 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. R.M. Bergenstal: Research Support; Self; Abbott, Boehringer Ingelheim Pharmaceuticals, Inc., Dexcom, Inc., Glooko, Inc., Hygieia, JDRF, Johnson & Johnson Medical Devices Companies, Lilly Diabetes, Medtronic MiniMed, Inc., Merck & Co., Inc., National Institute of Diabetes and Digestive and Kidney Diseases, Novo Nordisk Inc., Roche Diabetes Care, Sanofi. Other Relationship; Self; Abbott, Helmsley Charitable Trust, Hygieia, Lilly Diabetes, Novo Nordisk Inc., Onduo LLC, Sanofi, UnitedHealth Group Inc. R. Beck: Other Relationship; Self; Abbott Laboratories, Ascensia Diabetes Care, Bigfoot Biomedical, Dexcom, Inc., Insulet Corporation, Lilly Diabetes, Roche Diabetes Care, Tandem Diabetes Care. Funding The Leona M. and Harry B. Helmsley Charitable Trust

We examined characteristics of pregnant women aged 16-40 years with type 1 diabetes (T1D) enrolled in the T1D Exchange clinic registry. We compared characteristics of 3 cohorts of women with data collection periods from: 2010-12 (N=4651), 2011-13 (N=3355), and 2016-18 (N=2818). 2.9%, 2.2%, and 1.7% of women reported being pregnant during 2010-12, 2011-13, and 2016-18, respectively. For pregnant women, there was a trend for a decrease in HbA1c over the 3 time periods from 6.8% to 6.7% to 6.4% (P=0.13 adjusted for age, race/ethnicity, frequency of glucose monitoring, and use of CGM). Self-reported use of CGM while pregnant increased more than 2-fold over the time period (P=0.001 adjusted for age, duration, race/ethnicity, insurance status, and use of pump); conversely, self-reported pump use while pregnant remained unchanged (adjusted P=0.38) (Table). Severe hypoglycemia (seizure/loss of consciousness) was similar across cohorts (adjusted P=0.38).We found in a real-world population of pregnant women in the U.S., lower HbA1c levels compared to those pregnant 5-6 years ago. CGM use in pregnancy appears to have increased over time, with relatively low but stable participant-reported insulin pump use. Further explorations of these findings, ongoing assessment of real-world pregnancy outcomes and comparisons with data on T1D pregnant women from other large registries are needed. Disclosure C.J. Levy: Advisory Panel; Self; Novo Nordisk A/S, Sanofi. Employee; Spouse/Partner; Allergan. N.C. Foster: None. S. DuBose: None. S. Agarwal: None. S. Lyons: None. A.L. Peters: Advisory Panel; Self; Abbott, Becton, Dickinson and Company, Bigfoot Biomedical, Eli Lilly and Company, Lexicon Pharmaceuticals, Inc., Livongo Health, MannKind Corporation, Medscape, Merck & Co., Inc., Omada Health, Inc., OptumRx, Inc., Sanofi US, Zafgen, Inc. Research Support; Self; AstraZeneca, Dexcom, Inc., Jaeb Center for Health Research, MannKind Corporation, National Institute of Diabetes and Digestive and Kidney Diseases. Speaker's Bureau; Self; Novo Nordisk Inc. G.I. Uwaifo: None. L. DiMeglio: Research Support; Self; Amgen Inc., Caladrius Biosciences, Inc., Janssen Research & Development, Medtronic, Sanofi. Other Relationship; Self; Dexcom, Inc. J. Sherr: Advisory Panel; Self; Bigfoot Biomedical, Eli Lilly and Company, Insulet Corporation. Consultant; Self; Lexicon Pharmaceuticals, Inc., Medtronic, Sanofi. Research Support; Self; Dexcom, Inc., Insulet Corporation. S. Polsky: Consultant; Self; Jaeb Center for Health Research. Research Support; Self; Barbara Davis Center for Diabetes, Children's Diabetes Foundation, Dexcom, Inc., Eli Lilly and Company, JDRF, Leona & Harry Helmsley Charitable Trust, National Institute of Diabetes and Digestive and Kidney Diseases, Sanofi US. Funding The Leona M. and Harry B. Helmsley Charitable Trust

Aims To use a three-phase process to develop and validate new self-report measures of diabetes-specific health-related quality of life (HRQOL) for adults with type 1 diabetes. We report on four versions of the Type 1 Diabetes and Life (T1DAL) measure for people age 18–25, 26–45, 46–60, and over 60 years. Methods We first conducted qualitative interviews to guide measure creation, then piloted the draft measures. We evaluated psychometric properties at six T1D Exchange Clinic Network sites via completion of T1DAL and validated measures of related constructs. Participants completed the T1DAL again in 4–6 weeks. We used psychometric data to reduce each measure to 23–27 items in length. Finally, we obtained participant feedback on the final measures. Results The T1DAL-Adult measures demonstrated good internal consistency (α = 0.85–0.88) and test–retest reliability (r = 0.77–0.87). Significant correlations with measures of general quality of life, generic and diabetes-specific HRQOL, diabetes burden, self-management, and glycemic control demonstrated validity. Factor analyses yielded 4–5 subscales per measure. Participants were satisfied with the final measures and reported they took 5–10 min to complete. Conclusions The strong psychometric properties of the newly developed self-report T1DAL measures for adults with type 1 diabetes make them appropriate for use in clinical research and care.

Gestational tight glycemic control is critical for women with type 1 diabetes (T1D). Limited data exist on the adoption and retention of diabetes technologies among women in different parity strata.We compared T1D management between T1D Exchange clinic registry participants (mean age 28 ± 9 years, 84% white non-Hispanic, and median T1D duration 13 years) who were pregnant at enrollment or year 1 follow-up ("recently pregnant" between 2010 and 2013, n = 214), ever (but not recently) pregnant (n = 1540), and never pregnant (n = 2586). We examined self-reported maternal and fetal outcomes in 130 women who delivered a baby within the last year.Recently pregnant women had the lowest hemoglobin A1c (6.5% pregnant vs. 7.8% ever pregnant vs. 8.0% never pregnant, P 0.001). Recently pregnant women reported the highest use of continuous subcutaneous insulin infusion (74% vs. 60% vs. 58%, adjusted P 0.001) and continuous glucose monitor (CGM) (36% vs.17% vs. 12%, adjusted P 0.001) therapies compared with ever or never pregnant women, respectively, after adjusting for age, diabetes duration, and socioeconomic status. Among women 18-25 years old, CGM use was highest among recently pregnant women (adjusted P = 0.0022). Never pregnant women 26-45 years old had a higher use of CGM compared with younger counterparts (adjusted P 0.001). Adverse maternal and fetal outcomes were common.Despite high uptake levels of advanced diabetes technologies among pregnant women, rates of adverse maternal and fetal outcomes remain high. More studies are needed to determine how these technologies could be best used in pregnancy and postpartum to improve health outcomes among women with T1D.

We aim to understand the impact of HbA1c variability, as measured by SD-HbA1c, on risk of microalbuminuria in T1D population. An analysis was performed utilizing data of 8,680 participants in the T1D Exchange Clinic Registry (50% female, 86% non-Hispanic white, mean age 34 years, mean diabetes duration 14 years at enrollment) who met the following criteria: ≥2 clinic visit records, T1D duration ≥1 year at enrollment, age of diagnosis ≥10 years old and no known renal disease (including no microalbuminuria) at the time of registry enrollment. Median number of albuminuria and HbA1c measures were 4 and 21 per participant, respectively. Microalbuminuria was present during follow-up in 562 (6.5%) participants. Median intrapersonal mean HbA1c and SD-HbA1c were 7.8% and 0.6% respectively. Participants with high HbA1c variability had shorter time to first microalbuminuria (p Disclosure M.A. Clements: Speaker's Bureau; Self; Medtronic. Advisory Panel; Self; Glooko, Inc.. M. Wu: None. N.C. Foster: None. L.M. Laffel: Consultant; Self; Eli Lilly and Company, Novo Nordisk Inc., Sanofi US, MannKind Corporation, Roche Diagnostics Corporation, Dexcom, Inc., Insulet Corporation, AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Johnson & Johnson Diabetes Institute, LLC.. V.N. Shah: None. F. Vendrame: Consultant; Self; Novo Nordisk Inc.. R.S. Kingman: None. G.T. Alonso: None. A. Carlson: Advisory Panel; Self; Sanofi, Insulet Corporation. Consultant; Self; Merck & Co., Inc.. Research Support; Self; Medtronic, Novo Nordisk A/S. D.J. DeSalvo: Consultant; Self; Dexcom, Inc.. Speaker's Bureau; Self; Insulet Corporation. B.A. Buckingham: Advisory Panel; Self; Novo Nordisk Inc., ConvaTec Inc.. Research Support; Self; Medtronic, Insulet Corporation, Dexcom, Inc., Tandem Diabetes Care, Inc.. Consultant; Self; Tandem Diabetes Care, Inc., Becton, Dickinson and Company. J. Sherr: Consultant; Self; Medtronic MiniMed, Inc.. Advisory Panel; Self; Insulet Corporation, Eli Lilly and Company, Bigfoot Biomedical. R. Benjamin: Speaker's Bureau; Self; Pfizer Inc.. E. Eyth: None. S. DuBose: None.

OBJECTIVE Patients with type 1 diabetes who do aerobic exercise often experience a drop in blood glucose concentration that can result in hypoglycemia. Current approaches to prevent exercise-induced hypoglycemia include reduction in insulin dose or ingestion of carbohydrates, but these strategies may still result in hypoglycemia or hyperglycemia. We sought to determine whether mini-dose glucagon (MDG) given subcutaneously before exercise could prevent subsequent glucose lowering and to compare the glycemic response to current approaches for mitigating exercise-associated hypoglycemia. RESEARCH DESIGN AND METHODS We conducted a four-session, randomized crossover trial involving 15 adults with type 1 diabetes treated with continuous subcutaneous insulin infusion who exercised fasting in the morning at ∼55% VO2max for 45 min under conditions of no intervention (control), 50% basal insulin reduction, 40-g oral glucose tablets, or 150-μg subcutaneous glucagon (MDG). RESULTS During exercise and early recovery from exercise, plasma glucose increased slightly with MDG compared with a decrease with control and insulin reduction and a greater increase with glucose tablets (P < 0.001). Insulin levels were not different among sessions, whereas glucagon increased with MDG administration (P < 0.001). Hypoglycemia (plasma glucose CONCLUSIONS MDG may be more effective than insulin reduction for preventing exercise-induced hypoglycemia and may result in less postintervention hyperglycemia than ingestion of carbohydrate.

While data are accumulating on the association between neuropsychological performance and real-world endpoints, less is known about the association with medical self-management skills. The self-management of type 1 diabetes (T1D) is often complex, and mismanagement can result in hypoglycaemia and hyperglycaemia and associated morbidity and mortality. The T1D Exchange conducted a case-control study evaluating factors associated with severe hypoglycaemia in older adults (≥ 60 years old) with longstanding T1D (≥ 20 years). A battery of neuropsychological and functional assessments was administered, including measures of diabetes-specific self-management skill (diabetes numeracy) and instrumental activities of daily living (IADL). After adjusting for confounding variables, diabetes numeracy was related to memory and complex speeded attention; while IADL were associated with simple processing speed, executive functioning, complex speeded attention and dominant hand dexterity. The severity of overall cognitive deficit was uniquely associated with both diabetes numeracy and IADL, when controlling for age, education, frailty and depression. This study demonstrates that the cognitive deficits in older adults with T1D have functional implications for both diabetes management and IADL. Further research is needed to determine specific interventions to maximise diabetes self-management in older adults with declining cognition.

The prevalence of cardiovascular risk factors in children with type 1 diabetes and elevated BMI in the USA is poorly defined. We aimed to test the hypothesis that children with type 1 diabetes who are overweight or obese have increased frequencies of hypertension, dyslipidemia, and micro-/macroalbuminuria compared to their healthy weight peers. We studied 11,348 children 2 to

To examine the overall state of metabolic control and current use of advanced diabetes technologies in the U.S., we report recent data collected on individuals with type 1 diabetes participating in the T1D Exchange clinic registry. Data from 16,061 participants updated between 1 September 2013 and 1 December 2014 were compared with registry enrollment data collected from 1 September 2010 to 1 August 2012. Mean hemoglobin A1c (HbA1c) was assessed by year of age from 75 years. The overall average HbA1c was 8.2% (66 mmol/mol) at enrollment and 8.4% (68 mmol/mol) at the most recent update. During childhood, mean HbA1c decreased from 8.3% (67 mmol/mol) in 2–4-year-olds to 8.1% (65 mmol/mol) at 7 years of age, followed by an increase to 9.2% (77 mmol/mol) in 19-year-olds. Subsequently, mean HbA1c values decline gradually until ∼30 years of age, plateauing at 7.5–7.8% (58–62 mmol/mol) beyond age 30 until a modest drop in HbA1c below 7.5% (58 mmol/mol) in those 65 years of age. Severe hypoglycemia (SH) and diabetic ketoacidosis (DKA) remain all too common complications of treatment, especially in older (SH) and younger patients (DKA). Insulin pump use increased slightly from enrollment (58–62%), and use of continuous glucose monitoring (CGM) did not change (7%). Although the T1D Exchange registry findings are not population based and could be biased, it is clear that there remains considerable room for improving outcomes of treatment of type 1 diabetes across all age-groups. Barriers to more effective use of current treatments need to be addressed and new therapies are needed to achieve optimal metabolic control in people with type 1 diabetes.

Maltoni et al. (1) report a high prevalence (9.8%) of celiac disease (CD) in 2,164 youth with type 1 diabetes from five pediatric diabetes centers in northern Italy. This is considerably higher than in our recent report (3.5%) from three continents (U.K./Austria/Germany, U.S., and Australia) (2) and the pooled prevalence of 5.1% in a systematic review of CD in type 1 diabetes (3). Maltoni et al. propose that their higher rate of CD may be explained by more active screening programs in Italy. We agree that this is likely to be a contributing factor, as previous reports of high rates of coexisting CD and type 1 diabetes in Italy (4) and of CD in the general population may have heightened awareness of CD risk. It is of note, however, that we used a stringent definition of biopsy-proven CD and that a further …

Objectives Reduction of cardiovascular risk in children with type 1 diabetes requires aggressive management of hypertension (HTN). However, the frequency of diagnosing and effectively treating HTN in youth with type 1 diabetes has not been established. To address this question, we used the data collected in >9000 youth with type 1 diabetes who enrolled in the T1D Exchange Clinic Registry. Research design and methods This analysis included data from medical records of 9362 individuals with enrolment and 1-yr follow-up visits (age 3 to

OBJECTIVE To assess the frequency of continuous glucose monitoring (CGM) device use, factors associated with its use, and the relationship of CGM with diabetes outcomes (HbA1c, severe hypoglycemia [SH], and diabetic ketoacidosis [DKA]). RESEARCH DESIGN AND METHODS Survey questions related to CGM device use 1 year after enrollment in the T1D Exchange clinic registry were completed by 17,317 participants. Participants were defined as CGM users if they indicated using real-time CGM during the prior 30 days. RESULTS Nine percent of participants used CGM (6% of children CONCLUSIONS CGM use is uncommon but associated with lower HbA1c in some age-groups, especially when used more frequently. Factors associated with discontinuation and infrequent use of retrospective analysis of CGM data should be considered in developing next-generation devices and education on CGM use.

Insulin delivery via injection and continuous subcutaneous insulin infusion (CSII) via insulin pump were compared in a cross-sectional study (n = 669) and retrospective longitudinal study (n = 1904) of young children (

OBJECTIVE To examine factors associated with clinical microalbuminuria (MA) diagnosis in children and adolescents in the T1D Exchange clinic registry. RESEARCH DESIGN AND METHODS T1D Exchange participants RESULTS MA was present in 329 of 7,549 (4.4%) participants, with a higher frequency associated with longer diabetes duration, higher mean glycosylated hemoglobin (HbA1c) level, older age, female sex, higher diastolic blood pressure (BP), and lower BMI (P ≤ 0.01 for each in multivariate analysis). Older age was most strongly associated with MA among participants with HbA1c ≥9.5% (≥80 mmol/mol). MA was uncommon ( CONCLUSIONS Our results emphasize the importance of good glycemic and BP control, particularly as diabetes duration increases, in order to reduce the risk of nephropathy. Since age and diabetes duration are important nonmodifiable factors associated with MA, the importance of routine screening is underscored to ensure early diagnosis and timely treatment of MA.

Objective To compare characteristics of autoantibody (aAb)-positive and -negative cases of type 1 diabetes (T1D)

Objective Severe hypoglycemia (SH) and diabetic ketoacidosis (DKA) are common serious acute complications of type 1 diabetes (T1D). The aim of this study was to determine the frequency of SH and DKA and identify factors related to their occurrence in the T1D Exchange pediatric and young adult cohort. Research design and methods The analysis included 13 487 participants in the T1D Exchange clinic registry aged 2 to

Hypoglycemia is a major concern in older adults with type 1 diabetes (T1D) and there is limited knowledge in this population. We examined data from 199 adults, ≥60 years of age, who participated in a T1D Exchange study assessing factors associated with severe hypoglycemia (SH) in older adults with T1D: 100 with SH in the prior year and 99 with no SH in prior 3 years (mean age 68; mean diabetes duration 40 years; 47% female; 92% non-Hispanic white). Hypoglycemia was assessed with up to 14 days of blinded continuous glucose monitoring (CGM). Linear regression models were performed to assess the association between biochemical hypoglycemia [defined as percentage of time below specific cutoffs (70/60/50 mg/dL)] and various factors.Overall, participants had CGM values70 mg/dL for a median of 91 min per day. On 53% of days, glucose levels continuously were70 mg/dL for ≥20 min. Hypoglycemia was found to be strongly associated with glucose variability (r = 0.76; P 0.001). Time spent in hypoglycemia was greater in those who were younger (P = 0.004), had shorter diabetes duration (P = 0.008), lower HbA1c (P 0.001), and undetectable C-peptide (P = 0.001), but did not differ by insulin method, education level, number of blood glucose checks per day, cognition, activities of daily living, or fear of hypoglycemia.This study adds valuable data on the frequency of hypoglycemia in older adults with T1D.Future studies need to focus on how to prevent hypoglycemia in this vulnerable population of older adults with long-standing T1D.

The T1D Exchange includes a clinic-based registry, a patient-centric web site called Glu, and a biobank.The aim of the study was to describe the T1D Exchange clinic registry and provide an overview of participant characteristics.Data obtained through participant completion of a questionnaire and chart extraction include diabetes history, management, and monitoring; general health; lifestyle; family history; socioeconomic factors; medications; acute and chronic diabetic complications; other medical conditions; and laboratory results.Data were collected from 67 endocrinology centers throughout the United States.We studied 25,833 adults and children with presumed autoimmune type 1 diabetes (T1D).Participants ranged in age from less than 1 to 93 yr, 50% were female, 82% were Caucasian, 50% used an insulin pump, 6% used continuous glucose monitoring, and 16% had a first-degree family member with T1D. Glycosylated hemoglobin at enrollment averaged 8.3% and was highest in 13 to 25 yr olds. The prevalence of renal disease was ≤4% until T1D was present for at least 10 yr, and retinopathy treatment was ≤2% until T1D was present for at least 20 yr. A severe hypoglycemic event (seizure or coma) in the prior 12 months was reported by 7% of participants and diabetic ketoacidosis in the prior 12 months by 8%.The T1D Exchange clinic registry provides a database of important information on individuals with T1D in the United States. The rich dataset of the registry provides an opportunity to address numerous issues of relevance to clinicians and patients, including assessments of associations between patient characteristics and diabetes management factors with outcomes.

OBJECTIVE Severe hypoglycemia is common in older adults with long-standing type 1 diabetes, but little is known about factors associated with its occurrence. RESEARCH DESIGN AND METHODS A case-control study was conducted at 18 diabetes centers in the T1D Exchange Clinic Network. Participants were ≥60 years old with type 1 diabetes for ≥20 years. Case subjects (n = 101) had at least one severe hypoglycemic event in the prior 12 months. Control subjects (n = 100), frequency-matched to case subjects by age, had no severe hypoglycemia in the prior 3 years. Data were analyzed for cognitive and functional abilities, social support, depression, hypoglycemia unawareness, various aspects of diabetes management, C-peptide level, glycated hemoglobin level, and blinded continuous glucose monitoring (CGM) metrics. RESULTS Glycated hemoglobin (mean 7.8% vs. 7.7%) and CGM-measured mean glucose (175 vs. 175 mg/dL) were similar between case and control subjects. More case than control subjects had hypoglycemia unawareness: only 11% of case subjects compared with 43% of control subjects reported always having symptoms associated with low blood glucose levels (P < 0.001). Case subjects had greater glucose variability than control subjects (P = 0.008) and experienced CGM glucose levels CONCLUSIONS In older adults with long-standing type 1 diabetes, greater hypoglycemia unawareness and glucose variability are associated with an increased risk of severe hypoglycemia. A study to assess interventions to prevent severe hypoglycemia in high-risk individuals is needed.

To examine the current extent of the obesity problem in 2 large pediatric clinical registries in the US and Europe and to examine the hypotheses that increased body mass index (BMI) z-scores (BMIz) are associated with greater hemoglobin A1c (HbA1c) and increased frequency of severe hypoglycemia in youth with type 1 diabetes (T1D).International (World Health Organization) and national (Centers for Disease Control and Prevention/German Health Interview and Examination Survey for Children and Adolescents) BMI references were used to calculate BMIz in participants (age 2-18 years and ≥ 1 year duration of T1D) enrolled in the T1D Exchange (n = 11,435) and the Diabetes Prospective Follow-up (n = 21,501). Associations between BMIz and HbA1c and severe hypoglycemia were assessed.Participants in both registries had median BMI values that were greater than international and their respective national reference values. BMIz was significantly greater in the T1D Exchange vs the Diabetes Prospective Follow-up (P.001). After stratification by age-group, no differences in BMI between registries existed for children 2-5 years, but differences were confirmed for 6- to 9-, 10- to 13-, and 14- to 17-year age groups (all P.001). Greater BMIz were significantly related to greater HbA1c levels and more frequent occurrence of severe hypoglycemia across the registries, although these associations may not be clinically relevant.Excessive weight is a common problem in children with T1D in Germany and Austria and, especially, in the US. Our data suggest that obesity contributes to the challenges in achieving optimal glycemic control in children and adolescents with T1D.

Reduction of cardiovascular risk in children with type 1 diabetes requires aggressive management of hypertension (HTN). However, the frequency of diagnosing and effectively treating HTN in youth with type 1 diabetes has not been established. To address this question, we used the data collected in9000 youth with type 1 diabetes who enrolled in the T1D Exchange Clinic Registry.This analysis included data from medical records of 9362 individuals with enrolment and 1-yr follow-up visits (age 3 to18 yr, disease duration ≥ 1 yr at follow-up). Data included the prevalence of a documented diagnosis of HTN, elevated blood pressure (BP) (systolic or diastolic ≥95th percentile for age, gender, and height), and treatment with angiotensin converting enzyme (ACE)-receptor inhibitor (ACE-I)/angiotensin receptor blocker (ARB) therapy.HTN was diagnosed in only 1% (113/9362) of participants; yet, elevated BP was recorded at one of the two visits in 17% and at both visits in 4%. Among those with diagnosed HTN, only 52% (59/113) were receiving ACE-I/ARB therapy and only 32% (19 of 59) of those treated were at goal BP. Children with diagnosed HTN had higher HbA1c (adjusted p0.001) and higher BMI (p0.001) when compared with children without HTN.HTN is likely under diagnosed and undertreated even in pediatric diabetes clinics. The relatively low proportion of hypertensive children receiving ACE-I therapy and reaching BP goals probably identifies an important area for improving care in children with type 1 diabetes.

The study aimed to compare participant characteristics, treatment modalities and clinical outcomes in registry participants less than 6 years old. Participant characteristics, treatment modalities and clinical outcomes (HbA1c, severe hypoglycaemia [SH] and diabetic ketoacidosis [DKA]) as well as frequencies of attaining HbA1c goals in line with the International Society for Pediatric and Adolescent Diabetes (

Few studies have assessed factors associated with severe hypoglycemia (SH) and diabetic ketoacidosis (DKA) in adults with type 1 diabetes (T1D).Our objective was to determine frequency of and factors associated with the occurrence of SH and DKA in adults with T1D.We conducted a cross-sectional analysis from the T1D Exchange clinic registry at 70 U.S. endocrinology centers.Analysis included 7012 participants in the T1D Exchange clinic registry aged 26 to 93 years old with T1D for ≥2 years.Higher frequencies of SH and DKA were associated with lower socioeconomic status (P.001). SH was strongly associated with diabetes duration (P.001), with 18.6% of those with diabetes ≥40 years having an event in the past 12 months. SH frequency was lowest in those with hemoglobin A1c (HbA1c) levels of 7.0% (53 mmol/mol) to 7.5% (58 mmol/mol), being higher in those with HbA1c levels7.0% (53 mmol/mol) or7.5% (58 mmol/mol). DKA frequency increased with higher HbA1c levels (P.001), with 21.0% of those with HbA1c ≥10.0% (≥86 mmol/mol) having an event in the past 12 months.SH and DKA are more common in those with lower socioeconomic status. DKA, most common in those with HbA1c ≥10.0% (≥86 mmol/mol), should be largely preventable. In contrast, SH, most frequent with diabetes ≥40 years duration, cannot be abolished given the limitation of current therapies. To reduce SH in adults with longstanding diabetes, consideration should be given to modifying HbA1c goals, particularly in patients with very low HbA1c levels.

We thank Price et al. (1) for their comments on our recent article exploring use of continuous glucose monitoring (CGM) in the T1D Exchange Clinic Network registry (2). We acknowledge, as we did in the original article, that the experience of participants included in our study was based on older generations of CGM devices and agree with Price et al. that newer generations …