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62 result(s) for "Wadwa, R. Paul"
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Prevalence and Correlates of Depression in Individuals With and Without Type 1 Diabetes
OBJECTIVE: Depression is associated with poor glycemic control and complications in people with type 1 diabetes. We assessed the prevalence of depression and antidepressant medication use among adults with and without type 1 diabetes and the association between depression and diabetes complications. RESEARCH DESIGN AND METHODS: In 2006-2008, the Coronary Artery Calcification in Type 1 Diabetes Study applied the Beck Depression Inventory II (BDI-II) to 458 participants with type 1 diabetes (47% male, aged 44 ± 9 years, type 1 diabetes duration 29 ± 9 years) and 546 participants without diabetes (nondiabetic group) (51% male, aged 47 ± 9 years). Use of antidepressant medication was self-reported. Depression was defined as a BDI-II score >14 and/or use of antidepressant medication. Occurrence of diabetes complications (retinopathy, blindness, neuropathy, diabetes-related amputation, and kidney or pancreas transplantation) was self-reported. RESULTS: Mean BDI-II score, adjusted for age and sex, was significantly higher in participants with type 1 diabetes than in nondiabetic participants (least-squares mean ± SE: 7.4 ± 0.3 vs. 5.0 ± 0.3; P < 0.0001). Type 1 diabetic participants reported using more antidepressant medications (20.7 vs. 12.1%, P = 0.0003). More type 1 diabetic than nondiabetic participants were classified as depressed by BDI-II cut score (17.5 vs. 5.7%, P < 0.0001) or by either BDI-II cut score or antidepressant use (32.1 vs. 16.0%, P < 0.0001). Participants reporting diabetes complications (n = 209) had higher mean BDI-II scores than those without complications (10.7 ± 9.3 vs. 6.4 ± 6.3, P < 0.0001). CONCLUSIONS: Compared with nondiabetic participants, adults with type 1 diabetes report more symptoms of depression and more antidepressant medication usage. Depression is highly prevalent in type 1 diabetes and requires further study on assessment and treatment.
Closed loop control in adolescents and children during winter sports: Use of the Tandem Control‐IQ AP system
Objective Artificial pancreas (AP) systems have been shown to improve glycemic control throughout the day and night in adults, adolescents, and children. However, AP testing remains limited during intense and prolonged exercise in adolescents and children. We present the performance of the Tandem Control‐IQ AP system in adolescents and children during a winter ski camp study, where high altitude, low temperature, prolonged intense activity, and stress challenged glycemic control. Methods In a randomized controlled trial, 24 adolescents (ages 13‐18 years) and 24 school‐aged children (6‐12 years) with Type 1 diabetes (T1D) participated in a 48 hours ski camp (∼5 hours skiing/day) at three sites: Wintergreen, VA; Kirkwood, and Breckenridge, CO. Study participants were randomized 1:1 at each site. The control group used remote monitored sensor‐augmented pump (RM‐SAP), and the experimental group used the t: slim X2 with Control‐IQ Technology AP system. All subjects were remotely monitored 24 hours per day by study staff. Results The Control‐IQ system improved percent time within range (70‐180 mg/dL) over the entire camp duration: 66.4 ± 16.4 vs 53.9 ± 24.8%; P = .01 in both children and adolescents. The AP system was associated with a significantly lower average glucose based on continuous glucose monitor data: 161 ± 29.9 vs 176.8 ± 36.5 mg/dL; P = .023. There were no differences between groups for hypoglycemia exposure or carbohydrate interventions. There were no adverse events. Conclusions The use of the Control‐IQ AP improved glycemic control and safely reduced exposure to hyperglycemia relative to RM‐SAP in pediatric patients with T1D during prolonged intensive winter sport activities.
Predictive hyperglycemia and hypoglycemia minimization: In‐home double‐blind randomized controlled evaluation in children and young adolescents
Objective The primary objective of this trial was to evaluate the feasibility, safety, and efficacy of a predictive hyperglycemia and hypoglycemia minimization (PHHM) system vs predictive low glucose suspension (PLGS) alone in optimizing overnight glucose control in children 6 to 14 years old. Research Design and Methods Twenty‐eight participants 6 to 14 years old with T1D duration ≥1 year with daily insulin therapy ≥12 months and on insulin pump therapy for ≥6 months were randomized per night into PHHM mode or PLGS‐only mode for 42 nights. The primary outcome was percentage of time in sensor‐measured range 70 to 180 mg/dL in the overnight period. Results The addition of automated insulin delivery with PHHM increased time in target range (70‐180 mg/dL) from 66 ± 11% during PLGS nights to 76 ± 9% during PHHM nights (P<.001), without increasing hypoglycemia as measured by time below various thresholds. Average morning blood glucose improved from 176 ± 28 mg/dL following PLGS nights to 154 ± 19 mg/dL following PHHM nights (P<.001). Conclusions The PHHM system was effective in optimizing overnight glycemic control, significantly increasing time in range, lowering mean glucose, and decreasing glycemic variability compared to PLGS alone in children 6 to 14 years old.
Six-Month Randomized, Multicenter Trial of Closed-Loop Control in Type 1 Diabetes
Closed-loop systems that automate insulin delivery may improve glycemic outcomes in patients with type 1 diabetes. In this 6-month randomized, multicenter trial involving such patients, a closed-loop system led to a greater percentage of time with the glucose level in a target range than did a sensor-augmented insulin pump.
Trial of Hybrid Closed-Loop Control in Young Children with Type 1 Diabetes
Closed-loop control systems of insulin delivery may improve glycemic outcomes in young children with type 1 diabetes. The efficacy and safety of initiating a closed-loop system virtually are unclear. In this 13-week, multicenter trial, we randomly assigned, in a 2:1 ratio, children who were at least 2 years of age but younger than 6 years of age who had type 1 diabetes to receive treatment with a closed-loop system of insulin delivery or standard care that included either an insulin pump or multiple daily injections of insulin plus a continuous glucose monitor. The primary outcome was the percentage of time that the glucose level was in the target range of 70 to 180 mg per deciliter, as measured by continuous glucose monitoring. Secondary outcomes included the percentage of time that the glucose level was above 250 mg per deciliter or below 70 mg per deciliter, the mean glucose level, the glycated hemoglobin level, and safety outcomes. A total of 102 children underwent randomization (68 to the closed-loop group and 34 to the standard-care group); the glycated hemoglobin levels at baseline ranged from 5.2 to 11.5%. Initiation of the closed-loop system was virtual in 55 patients (81%). The mean (±SD) percentage of time that the glucose level was within the target range increased from 56.7±18.0% at baseline to 69.3±11.1% during the 13-week follow-up period in the closed-loop group and from 54.9±14.7% to 55.9±12.6% in the standard-care group (mean adjusted difference, 12.4 percentage points [equivalent to approximately 3 hours per day]; 95% confidence interval, 9.5 to 15.3; P<0.001). We observed similar treatment effects (favoring the closed-loop system) on the percentage of time that the glucose level was above 250 mg per deciliter, on the mean glucose level, and on the glycated hemoglobin level, with no significant between-group difference in the percentage of time that the glucose level was below 70 mg per deciliter. There were two cases of severe hypoglycemia in the closed-loop group and one case in the standard-care group. One case of diabetic ketoacidosis occurred in the closed-loop group. In this trial involving young children with type 1 diabetes, the glucose level was in the target range for a greater percentage of time with a closed-loop system than with standard care. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases; PEDAP ClinicalTrials.gov number, NCT04796779.).
Nasal Glucagon Reverses Insulin-induced Hypoglycemia With Less Rebound Hyperglycemia: Pooled Analysis of Clinical Trials
Abstract Background Rebound hyperglycemia may occur following glucagon treatment for severe hypoglycemia. We assessed rebound hyperglycemia occurrence after nasal glucagon (NG) or injectable glucagon (IG) administration in patients with type 1 diabetes (T1D) and type 2 diabetes (T2D). Methods This was a pooled analysis of 3 multicenter, randomized, open-label studies (NCT03339453, NCT03421379, NCT01994746) in patients ≥18 years with T1D or T2D with induced hypoglycemia. Proportions of patients achieving treatment success [blood glucose (BG) increase to ≥70 mg/dL or increase of ≥20 mg/dL from nadir within 15 and 30 minutes]; BG ≥70 mg/dL within 15 minutes; in-range BG (70-180 mg/dL) 1 to 2 and 1 to 4 hours postdose; and BG >180 mg/dL 1 to 2 and 1 to 4 hours postdose were compared. Incremental area under curve (iAUC) of BG >180 mg/dL and area under curve (AUC) of observed BG values postdose were analyzed. Safety was assessed in all studies. Results Higher proportions of patients had in-range BG with NG vs IG (1-2 hours: P = .0047; 1-4 hours: P = .0034). Lower proportions of patients had at least 1 BG value >180 mg/dL with NG vs IG (1-2 hours: P = .0034; 1-4 hours: P = .0068). iAUC and AUC were lower with NG vs IG (P = .025 and P < .0001). As expected, similar proportions of patients receiving NG or IG achieved treatment success at 15 and 30 minutes (97-100%). Most patients had BG ≥70 mg/dL within 15 minutes (93-96%). The safety profile was consistent with previous studies. Conclusion This study demonstrated lower rebound hyperglycemia risk after NG treatment compared with IG. Clinical Trial Registration NCT03421379, NCT03339453, NCT01994746
A Randomized Trial of Closed-Loop Control in Children with Type 1 Diabetes
A closed-loop system (also called an artificial pancreas) may improve glycemic outcomes in children with type 1 diabetes. In this 16-week trial, the glucose level was in the target range for a greater percentage of time with a closed-loop system than with a sensor-augmented insulin pump.
The Association between Vitamin D and Vascular Stiffness in Adolescents with and without Type 1 Diabetes
Vitamin D deficiency is common and associated with increased cardiovascular disease (CVD) risk. Pulse wave velocity (PWV) is a marker of vascular stiffness associated with CVD. We hypothesized that Vitamin D (25 (OH) D) levels would be inversely associated with PWV in youth with and without type 1 diabetes (T1D). Comparisons were made between adolescents with T1D (n = 211; age = 17.5 ± 2.3 years; diabetes duration = 10.9 ± 3.2 years; A1c = 9.1 ± 1.7%) and non-DM controls (n = 67; age = 16.9 ± 1.9 years). PWV was measured in the carotid-femoral segment (Sphygmocor Vx, AtCor Medical, Lisle, IL). Vitamin D levels were similar in adolescents with T1D and controls (27.7 ± 0.7 v. 26.0 ± 1.3 ng/ml; p = 0.26). Vitamin D was significantly inversely associated with PWV after adjusting for age, sex, quarter of the year, and race-ethnicity in adolescents with T1D (beta = -0.01 ± 0.004, p = 0.02) but not in the non-DM adolescents (beta = -0.008 ± 0.008, p = 0.32). Vitamin D remained significantly associated with PWV after additionally adjusting for hs-CRP in adolescents with T1D (-0.01 ± 0.004, p = 0.01). After adjusting for BMI z-score, lipids, or blood pressure, the relationship of Vitamin D with PWV was not significant. Vitamin D levels were inversely associated with PWV in adolescents with T1D, but not independently of BMI, lipids, or blood pressure. Our data contrast with other reports and suggest further research is indicated to determine if Vitamin D supplementation would be beneficial to lower CVD risk in adolescents with T1D with vitamin D insufficiency or deficiency.
Real world hybrid closed‐loop discontinuation: Predictors and perceptions of youth discontinuing the 670G system in the first 6 months
Objective To describe predictors of hybrid closed loop (HCL) discontinuation and perceived barriers to use in youth with type 1 diabetes. Subjects Youth with type 1 diabetes (eligible age 2‐25 y; recruited age 8‐25 y) who initiated the Minimed 670G HCL system were followed prospectively for 6 mo in an observational study. Research Design and Methods Demographic, glycemic (time‐in‐range, HbA1c), and psychosocial variables [Hypoglycemia Fear Survey (HFS); Problem Areas in Diabetes (PAID)] were collected for all participants. Participants who discontinued HCL (<10% HCL use at clinical visit) completed a questionnaire on perceived barriers to HCL use. Results Ninety‐two youth (15.7 ± 3.6 y, HbA1c 8.8 ± 1.3%, 50% female) initiated HCL, and 28 (30%) discontinued HCL, with the majority (64%) discontinuing between 3 and 6 mo after HCL start. Baseline HbA1c predicted discontinuation (P = .026) with the odds of discontinuing 2.7 times higher (95% CI: 1.123, 6.283) for each 1% increase in baseline HbA1c. Youth who discontinued HCL rated difficulty with calibrations, number of alarms, and too much time needed to make the system work as the most problematic aspects of HCL. Qualitatively derived themes included technological difficulties (error alerts, not working correctly), too much work (calibrations, fingersticks), alarms, disappointment in glycemic control, and expense (cited by parents). Conclusions Youth with higher HbA1c are at greater risk for discontinuing HCL than youth with lower HbA1c, and should be the target of new interventions to support device use. The primary reasons for discontinuing HCL relate to the workload required to use HCL.