Effect of Tight Glycemic Control on Pancreatic Beta Cell Function in Newly Diagnosed Pediatric Type 1 Diabetes: A Randomized Clinical Trial.

Importance: Near normalization of glucose levels instituted immediately after diagnosis of type 1 diabetes has been postulated to preserve pancreatic beta cell function by reducing glucotoxicity. Previous studies have been hampered by an inability to achieve tight glycemic goals. Objective: To determine the effectiveness of intensive diabetes management to achieve near normalization of glucose levels on preservation of pancreatic beta cell function in youth with newly diagnosed type 1 diabetes. Design, Setting, and Participants: This randomized, double-blind, clinical trial was conducted at 6 centers in the US (randomizations from July 20, 2020, to October 13, 2021; follow-up completed September 15, 2022) and included youths with newly diagnosed type 1 diabetes aged 7 to 17 years. Interventions: Random assignment to intensive diabetes management, which included use of an automated insulin delivery system (n = 61), or standard care, which included use of a continuous glucose monitor (n = 52), as part of a factorial design in which participants weighing 30 kg or more also were assigned to receive either oral verapamil or placebo. Main Outcomes and Measures: The primary outcome was mixed-meal tolerance test-stimulated C-peptide area under the curve (a measure of pancreatic beta cell function) 52 weeks from diagnosis. Results: Among 113 participants (mean [SD] age, 11.8 [2.8] years; 49 females [43%]; mean [SD] time from diagnosis to randomization, 24 [5] days), 108 (96%) completed the trial. The mean C-peptide area under the curve decreased from 0.57 pmol/mL at baseline to 0.45 pmol/mL at 52 weeks in the intensive management group, and from 0.60 to 0.50 pmol/mL in the standard care group (treatment group difference, -0.01 [95% CI, -0.11 to 0.10]; P = .89). The mean time in the target range of 70 to 180 mg/dL, measured with continuous glucose monitoring, at 52 weeks was 78% in the intensive management group vs 64% in the standard care group (adjusted difference, 16% [95% CI, 10% to 22%]). One severe hypoglycemia event and 1 diabetic ketoacidosis event occurred in each group. Conclusions and Relevance: In youths with newly diagnosed type 1 diabetes, intensive diabetes management, which included automated insulin delivery, achieved excellent glucose control but did not affect the decline in pancreatic C-peptide secretion at 52 weeks. Trial Registration: ClinicalTrials.gov Identifier: NCT04233034.

Effect of Verapamil on Pancreatic Beta Cell Function in Newly Diagnosed Pediatric Type 1 Diabetes: A Randomized Clinical Trial.

Importance: In preclinical studies, thioredoxin-interacting protein overexpression induces pancreatic beta cell apoptosis and is involved in glucotoxicity-induced beta cell death. Calcium channel blockers reduce these effects and may be beneficial to beta cell preservation in type 1 diabetes. Objective: To determine the effect of verapamil on pancreatic beta cell function in children and adolescents with newly diagnosed type 1 diabetes. Design, Setting, and Participants: This double-blind, randomized clinical trial including children and adolescents aged 7 to 17 years with newly diagnosed type 1 diabetes who weighed 30 kg or greater was conducted at 6 centers in the US (randomized participants between July 20, 2020, and October 13, 2021) and follow-up was completed on September 15, 2022. Interventions: Participants were randomly assigned 1:1 to once-daily oral verapamil (n = 47) or placebo (n = 41) as part of a factorial design in which participants also were assigned to receive either intensive diabetes management or standard diabetes care. Main Outcomes and Measures: The primary outcome was area under the curve values for C-peptide level (a measure of pancreatic beta cell function) stimulated by a mixed-meal tolerance test at 52 weeks from diagnosis of type 1 diabetes. Results: Among 88 participants (mean age, 12.7 [SD, 2.4] years; 36 were female [41%]; and the mean time from diagnosis to randomization was 24 [SD, 4] days), 83 (94%) completed the trial. In the verapamil group, the mean C-peptide area under the curve was 0.66 pmol/mL at baseline and 0.65 pmol/mL at 52 weeks compared with 0.60 pmol/mL at baseline and 0.44 pmol/mL at 52 weeks in the placebo group (adjusted between-group difference, 0.14 pmol/mL [95% CI, 0.01 to 0.27 pmol/mL]; P = .04). This equates to a 30% higher C-peptide level at 52 weeks with verapamil. The percentage of participants with a 52-week peak C-peptide level of 0.2 pmol/mL or greater was 95% (41 of 43 participants) in the verapamil group vs 71% (27 of 38 participants) in the placebo group. At 52 weeks, hemoglobin A1c was 6.6% in the verapamil group vs 6.9% in the placebo group (adjusted between-group difference, -0.3% [95% CI, -1.0% to 0.4%]). Eight participants (17%) in the verapamil group and 8 participants (20%) in the placebo group had a nonserious adverse event considered to be related to treatment. Conclusions and Relevance: In children and adolescents with newly diagnosed type 1 diabetes, verapamil partially preserved stimulated C-peptide secretion at 52 weeks from diagnosis compared with placebo. Further studies are needed to determine the longitudinal durability of C-peptide improvement and the optimal length of therapy. Trial Registration: ClinicalTrials.gov Identifier: NCT04233034.

Assessing Health-Related Quality of Life in Children and Adolescents with Diabetes: Development and Psychometrics of the Type 1 Diabetes and Life (T1DAL) Measures.

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.

Sex- and age-dependent effects of celiac disease on growth and weight gain in children with type 1 diabetes: Analysis of the type 1 diabetes Exchange Clinic Registry.

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.

The relationship between neuropsychological assessment, numeracy, and functional status in older adults with type 1 diabetes.

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.

Therapeutic inertia: underdiagnosed and undertreated hypertension in children participating in the T1D Exchange Clinic Registry.

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 <18 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. RESULTS: 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 p < 0.001) and higher BMI (p < 0.001) when compared with children without HTN. CONCLUSIONS: 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.

Obesity in Youth with Type 1 Diabetes in Germany, Austria, and the United States.

OBJECTIVE: 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). STUDY DESIGN: 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. RESULTS: 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. CONCLUSIONS: 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.

Contrasting the clinical care and outcomes of 2,622 children with type 1 diabetes less than 6 years of age in the United States T1D Exchange and German/Austrian DPV registries.

AIMS/HYPOTHESIS: The study aimed to compare participant characteristics, treatment modalities and clinical outcomes in registry participants less than 6 years old. METHODS: 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 (<7.5% [<58 mmol/mol]) and ADA (<8.5% [<69 mmol/mol]) were compared. RESULTS: Insulin pump use was more frequent (74% vs 50%, p < 0.001) and HbA1c levels lower in the Prospective Diabetes Follow-up Registry (DPV) than in the T1D Exchange (T1DX) (mean 7.4% vs 8.2%, p < 0.001). A lower HbA1c level was seen in the DPV compared with the T1DX for both pump users (p < 0.001) and injection users (p < 0.001). More children from DPV were meeting the recommended HbA1c goals, compared with children from T1DX (HbA1c <7.5%: 56% vs 22%, p < 0.001; HbA1c <8.5%: 90% vs 66%, p < 0.001). The adjusted odds of having an HbA1c level <7.5% or <8.5% were 4.2 (p < 0.001) and 3.6 (p < 0.001) higher for the DPV than the T1DX, respectively. The frequency of SH did not differ between registries or by HbA1c, whereas the frequency of DKA was higher for the T1DX and greater in those with higher HbA1c levels. CONCLUSIONS/INTERPRETATION: DPV data indicate that an HbA1c of <7.5% can frequently be achieved in children with type 1 diabetes who are under 6 years old. An improved metabolic control of type 1 diabetes in young patients appears to decrease the risk of DKA without increasing SH. The greater frequency of suboptimal control in young patients in the T1DX compared with the DPV is not fully explained by a less frequent use of insulin pumps and may relate to the higher HbA1c targets that are recommended for this age group in the USA.

Insulin pump use in young children in the T1D Exchange clinic registry is associated with lower hemoglobin A1c levels than injection therapy.

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 (<6 yr) with type 1 diabetes (T1D) participating in the T1D Exchange clinic registry. Use of CSII correlated with longer T1D duration (p < 0.001), higher parental education (p < 0.001), and annual household income (p < 0.006) but not with race/ethnicity. Wide variation in pump use was observed among T1D Exchange centers even after adjusting for these factors, suggesting that prescriber preference is a substantial determinant of CSII use. Hemoglobin A1c (HbA1c) was lower in pump vs. injection users (7.9 vs. 8.5%, adjusted p < 0.001) in the cross-sectional study. In the longitudinal study, HbA1c decreased after initiation of CSII by 0.2%, on average (p < 0.001). Frequency of a severe hypoglycemia (SH) event did not differ in pump vs. injection users (p = 0.2). Frequency of ≥1 parent-reported diabetic ketoacidosis (DKA) event in the prior year was greater in pump users than injection users (10 vs. 8%, p = 0.04). No differences between pump and injection users were observed for clinic-reported DKA events. Children below 6 yr have many unique metabolic characteristics, feeding behaviors, and care needs compared with older children and adolescents. These data support the use of insulin pumps in this youngest age group, and suggest that metabolic control may be improved without increasing the frequency of SH, but care should be taken as to the possibly increased risk of DKA.

Population Percentage and Population Size of Men Who Have Sex With Men in the United States, 2017-2021: Meta-Analysis of 5 Population-Based Surveys.

BACKGROUND: Male-to-male sexual transmission continues to account for the greatest proportion of new HIV diagnoses in the United States. However, calculating population-specific surveillance metrics for HIV and other sexually transmitted infections requires regularly updated estimates of the number and proportion of men who have sex with men (MSM) in the United States, which are not collected by census surveys. OBJECTIVE: The purpose of this analysis was to estimate the number and percentage of MSM in the United States from population-based surveys. METHODS: We used data from 5 population-based surveys to calculate weighted estimates of the proportion of MSM in the United States and pooled these estimates using meta-analytic procedures. We estimated the proportion of MSM using sexual behavior-based questions (encompassing anal or oral sex) for 3 recall periods-past 12 months, past 5 years, and lifetime. In addition, we estimated the proportion of MSM using self-reported identity and attraction survey responses. The total number of MSM and non-MSM in the United States were calculated from estimates of the percentage of MSM who reported sex with another man in the past 12 months. RESULTS: The percentage of MSM varied by recall period: 3.3% (95% CI 1.7%-4.9%) indicated sex with another male in the past 12 months, 4.7% (95% CI 0.0%-33.8%) in the past 5 years, and 6.2% (95% CI 2.9%-9.5%) in their lifetime. There were comparable percentages of men who identified as gay or bisexual (3.4%, 95% CI 2.2%-4.6%) or who indicated that they are attracted to other men (4.9%, 95% CI 3.1%-6.7%) based on pooled estimates. Our estimate of the total number of MSM in the United States is 4,230,000 (95% CI 2,179,000-6,281,000) based on the history of recent sexual behavior (sex with another man in the past 12 months). CONCLUSIONS: We calculated the pooled percentage and number of MSM in the United States from a meta-analysis of population-based surveys collected from 2017 to 2021. These estimates update and expand upon those derived from the Centers for Disease Control and Prevention in 2012 by including estimates of the percentage of MSM based on sexual identity and sexual attraction. The percentage and number of MSM in the United States is an important indicator for calculating population-specific disease rates and eligibility for preventive interventions such as pre-exposure prophylaxis.

Validation of a claims-based algorithm to identify pre-exposure prophylaxis indications for tenofovir disoproxil fumarate/emtricitabine prescriptions, United States, 2012-2014: algorithm validation by medical records review.

BACKGROUND: To monitor the use of tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) and related medicines for pre-exposure prophylaxis (PrEP) as HIV prevention using commercial pharmacy data, it is necessary to determine whether TDF/FTC prescriptions are used for PrEP, or for some other clinical indication. OBJECTIVE: To validate an algorithm to distinguish the use of TDF/FTC for HIV prevention or infectious disease treatment. METHODS: An algorithm was developed to identify whether TDF/FTC prescriptions were for PrEP or for other indications from large-scale administrative databases. The algorithm identifies TDF/FTC prescriptions, and then excludes patients with International Classification of Diseases (ICD)-9 diagnostic codes, medications or procedures that suggest indications other than for PrEP (e.g., documentation of HIV infection, chronic hepatitis B (CHB), or use of TDF/FTC for post-exposure prophylaxis (PEP)). For evaluation, we collected data by clinician assessment of medical records for patients with TDF/FTC, and compared the assessed indication identified by the clinician review with the assessed indication identified by the algorithm. The algorithm was then applied and evaluated in a large urban community-based sexual health clinic. RESULTS: The PrEP algorithm demonstrated high sensitivity and moderate specificity (99.6%, 49.6%) in the electronic medical record database, and high sensitivity and specificity (99%, 87%) in data from the urban community health clinic. CONCLUSIONS: The PrEP algorithm classified the indication for PrEP in most subjects treated with TDF/FTC with sufficient accuracy to be useful for surveillance purposes. The methods described can serve as a basis for developing a robust and evolving case definition for antiretroviral prescriptions for HIV prevention purposes. CLINICALTRIAL: None required.

Equity of PrEP uptake by race, ethnicity, sex and region in the United States in the first decade of PrEP: a population-based analysis.

Background: PrEP was approved for HIV prevention in the US in 2012; uptake has been slow. We describe relative equity with the PrEP Equity Ratio (PER), a ratio of PrEP-to-Need Ratios (PnRs). Methods: We used commercial pharmacy data to enumerate PrEP users by race and ethnicity, sex, and US Census region from 2012 to 2021. We report annual race and ethnicity-, sex-, and region-specific rates of PrEP use and PnR, a metric of PrEP equity, to assess trends. Findings: PrEP use increased for Black, Hispanic and White Americans from 2012 to 2021. By 2021, the rate of PrEP use per population was similar in Black and White populations but slightly lower among Hispanic populations. PnR increased from 2012 to 2021 for all races and ethnicities and regions; levels of PrEP use were inconsistent across regions and highly inequitable by race, ethnicity, and sex. In all regions, PnR was highest for White and lowest for Black people. Inequity in PrEP use by race and ethnicity, as measured by the PER, grew early after availability of PrEP and persisted at a level substantially below equitable PrEP use. Interpretation: From 2012 to 2021, PrEP use increased among Americans, but PrEP equity for Black and Hispanic Americans decreased. The US South lagged all regions in equitable PrEP use. Improved equity in PrEP use will be not only just, but also impactful on the US HIV epidemic; persons most at-risk of acquiring HIV should have the highest levels of access to PrEP. Prevention programs should be guided by PrEP equity, not PrEP equality. Funding: National Institutes of Health, Gilead Sciences.

Severe hypoglycemia and diabetic ketoacidosis among youth with type 1 diabetes in the T1D Exchange clinic registry.

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 <26 yr with T1D ≥2 yr. Separate logistic regression models were used to evaluate the association of baseline demographic and clinical factors with the occurrence of SH or DKA in the prior 12 months. RESULTS: Non-White race, no private health insurance, and lower household income were associated with higher frequencies of both SH and DKA (p < 0.001). SH frequency was highest in children <6 yr old (p = 0.005), but across the age range, SH was not associated with hemoglobin A1c (HbA1c) levels after controlling for other factors (p = 0.72). DKA frequency was highest in adolescents (p < 0.001) and associated with higher HbA1c (p < 0.001). CONCLUSIONS: Our data show that poor glycemic control increases the risk of DKA but does not protect against SH in youth and young adults with type 1 diabetes. The high frequencies of SH and DKA observed in disadvantaged minorities with T1D highlight the need for targeted interventions and new treatment paradigms for patients in these high risk groups.

Continuous Glucose Monitoring Profiles in Healthy, Nondiabetic Young Children.

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 ±â€…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.

Incident diabetes complications among women with type 1 diabetes based on parity.

OBJECTIVES: To assess risk factors and incidence of diabetes complications in women with type 1 diabetes (T1D) based on parity. RESEARCH DESIGN/METHODS: 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 (n = 28) and never pregnant women by year 5 (n = 469). RESULTS: There was a trend for lower HbA1c (adjusted p = .14) and higher rates of overweight/obesity, triglyceride/HDL > 2, log (triglyercide/HDL), and hypertension among parous women compared with nulliparous women. There were no significant differences in rates of advanced nephropathy, albuminuria or cardiovascular disease. CONCLUSIONS: Four-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.

Real-World, Patient-Reported and Clinic Data from Individuals with Type 1 Diabetes Using the MiniMed 670G Hybrid Closed-Loop System.

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 as part of usual care. We sought to expand current knowledge to understand how use of the system impacts patient-reported outcomes, in addition to clinical outcomes, for children and adults with T1D. Methods: Questionnaires were completed by the participant (and/or parent) before initiation of the 670G system (baseline) and at 6 weeks, 6 months, and 12 months from enrollment. Clinical data were obtained at routine clinical visits. Results: Of 132 participants who initiated Auto Mode, 80 completed the 12-month questionnaires while persisting with the system. Nearly all reported receiving adequate training on the 670G. Participant and parent-reported fear of hypoglycemia decreased by 6 and 11 points, respectively, from baseline to 12 months. More than half reported issues with sleep interruption at night due to alarms and 40% did not like frequent exits from Auto Mode. For the subset who had complete continuous glucose monitor data (n = 27), mean percent time in target range (70-180 mg/dL) was 66% at baseline, and 74% and 68% at 6 and 12 months, respectively. Conclusions: With this study, we have captured real-time feedback from patients with T1D who initiated the 670G system and continued to use it over 12 months regarding their experience with the system. This has helped to illuminate both benefits and burdens associated with the first commercially available hybrid closed-loop system.

Effect of Exercise and Meals on Continuous Glucose Monitor Data in Healthy Individuals Without Diabetes.

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.

Changes in Device Uptake and Glycemic Control Among Pregnant Women With Type 1 Diabetes: Data From the T1D Exchange.

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.

Health-related quality of life in parents and partners of people with type 1 diabetes: Development and validation of type 1 diabetes and life (T1DAL) measures.

INTRODUCTION: Despite the significant impact of type 1 diabetes (T1D) on family, few instruments are available to assess health-related quality of life (HRQOL) among family members of people with T1D. This study aimed to develop and evaluate the psychometric properties of new measures of diabetes-specific HRQOL for parents and partners of people with T1D. We report on the multistep development and validation process for the self-report Type 1 Diabetes and Life (T1DAL) measures, with versions for parents of youth age <8, 8-11, 12-17, and 18-25 years, and for partners of people age ≥18 years with T1D. METHOD: First, we conducted qualitative interviews (total parents/partners n = 38) to develop draft measures and piloted them (total n = 20). Next, we tested the measures' psychometric properties. Participants (total across versions n = 813) at six T1D Exchange Clinic Network sites completed the appropriate T1DAL measure and validated measures of related constructs. We then reduced each T1DAL measure to 20-30 items in length based on psychometric data and participant feedback. Eleven participants reviewed the final measures via cognitive debriefing. RESULTS: The T1DAL measures for parents and partners demonstrated good internal consistency (α = .80-.88) and test-retest reliability (r = .73-.86). Correlations with measures of general quality of life, generic and diabetes-specific HRQOL, and diabetes burden demonstrated construct validity. Factor analyses identified 3-4 subscales/measure. Participants reported being satisfied with the shortened measures, which took 5-10 minutes to complete. DISCUSSION: The new T1DAL measures for parents and partners of people with T1D are reliable, valid, and ready for use in research and clinical settings. (PsycInfo Database Record (c) 2021 APA, all rights reserved).

Design and psychometrics for new measures of health-related quality of life in adults with type 1 diabetes: Type 1 Diabetes and Life (T1DAL).

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.