Predictive Low-Glucose Suspend Reduces Hypoglycemia in Adults, Adolescents, and Children With Type 1 Diabetes in an At-Home Randomized Crossover Study: Results of the PROLOG Trial.

OBJECTIVE: This study evaluated a new insulin delivery system designed to reduce insulin delivery when trends in continuous glucose monitoring (CGM) glucose concentrations predict future hypoglycemia. RESEARCH DESIGN AND METHODS: Individuals with type 1 diabetes (n = 103, age 6-72 years, mean HbA1c 7.3% [56 mmol/mol]) participated in a 6-week randomized crossover trial to evaluate the efficacy and safety of a Tandem Diabetes Care t:slim X2 pump with Basal-IQ integrated with a Dexcom G5 sensor and a predictive low-glucose suspend algorithm (PLGS) compared with sensor-augmented pump (SAP) therapy. The primary outcome was CGM-measured time <70 mg/dL. RESULTS: Both study periods were completed by 99% of participants; median CGM usage exceeded 90% in both arms. Median time <70 mg/dL was reduced from 3.6% at baseline to 2.6% during the 3-week period in the PLGS arm compared with 3.2% in the SAP arm (difference [PLGS - SAP] = -0.8%, 95% CI -1.1 to -0.5, P < 0.001). The corresponding mean values were 4.4%, 3.1%, and 4.5%, respectively, represent-ing a 31% reduction in the time <70 mg/dL with PLGS. There was no increase in mean glucose concentration (159 vs. 159 mg/dL, P = 0.40) or percentage of time spent >180 mg/dL (32% vs. 33%, P = 0.12). One severe hypoglycemic event occurred in the SAP arm and none in the PLGS arm. Mean pump suspension time was 104 min/day. CONCLUSIONS: The Tandem Diabetes Care Basal-IQ PLGS system significantly reduced hypoglycemia without rebound hyperglycemia, indicating that the system can benefit adults and youth with type 1 diabetes in improving glycemic control.

Body mass index changes in youth in the first year after type 1 diabetes diagnosis.

OBJECTIVES: To describe changes in weight and body mass index (BMI) during the first year following diagnosis of type 1 diabetes (T1D) and associations with demographic and clinical characteristics. STUDY DESIGN: The Pediatric Diabetes Consortium includes 7 US centers with prospective longitudinal data from initial T1D diagnosis. This analysis includes 530 youth with diabetes duration of ≥1 year and measures of BMI at 3 and 12 months after diagnosis. BMI trajectory of participants and relationships between the change in BMI z-score from baseline (3 months) to 12 months with demographic characteristics, hemoglobin A1c at baseline, and insulin delivery mode at baseline were evaluated. RESULTS: As a group, BMI z-scores increased sharply from diagnosis for 1-3 months but remained relatively stable from +0.51 at 3 months to +0.48 at 12 months. Children aged 2-<5 years experienced a significant positive change in BMI z-score between 3 and 12 months, and there was a similar trend among girls that did not reach statistical significance. No significant differences were found for race, socioeconomic status, or insulin delivery mode. CONCLUSIONS: These data suggest that increased BMI during the first year of treatment of most youth with T1D reflects regain of weight lost before diagnosis. There is, however, a propensity toward additional weight gain in younger children and girls.

Diabetic ketoacidosis at diabetes onset: still an all too common threat in youth.

OBJECTIVE: To define the demographic and clinical characteristics of children at the onset of type 1 diabetes (T1D), with particular attention to the frequency of diabetic ketoacidosis (DKA). STUDY DESIGN: The Pediatric Diabetes Consortium enrolled children with new-onset T1D into a common database. For this report, eligible subjects were aged <19 years, had a pH or HCO(3) value recorded at diagnosis, and were positive for at least one diabetes-associated autoantibody. Of the 1054 children enrolled, 805 met the inclusion criteria. A pH of <7.3 and/or HCO(3) value of <15 mEq/L defined DKA. Data collected included height, weight, hemoglobin A1c, and demographic information (eg, race/ethnicity, health insurance status, parental education, family income). RESULTS: The 805 children had a mean age of 9.2 years, 50% were female; 63% were non-Hispanic Caucasian. Overall, 34% of the children presented in DKA, half with moderate or severe DKA (pH <7.2). The risk for DKA was estimated as 54% in children aged <3 years and 33% in those aged ≥ 3 years (P = .006). In multivariate analysis, younger age (P = .002), lack of private health insurance (P < .001), African-American race (P = .01), and no family history of T1D (P = .001) were independently predictive of DKA. The mean initial hemoglobin A1c was higher in the children with DKA compared with those without DKA (12.5% ± 1.9% vs 11.1% ± 2.4%; P < .001). CONCLUSION: The incidence of DKA in children at the onset of T1D remains high, with approximately one-third presenting with DKA and one-sixth with moderate or severe DKA. Increased awareness of T1D in the medical and lay communities is needed to decrease the incidence of this life-threatening complication.