Psychosocial benefits of insulin pump therapy in children with diabetes type 1 and their families: The pumpkin multicenter randomized controlled trial.

OBJECTIVE: Continuous subcutaneous insulin infusion (CSII) is on the rise among pediatric patients with type 1 diabetes mellitus. Metabolic effects alone cannot explain this rising popularity. From the patient's perspective, the main benefits of CSII may be found in subjective psychosocial health outcomes (patient-reported outcomes [PRO]). SUBJECTS AND METHODS: In a multicenter open randomized controlled trial, children and adolescents aged 6 to16 years currently treated with multiple daily injections (MDI) were randomized 1:1, stratified by center, to either starting with CSII immediately after the baseline interview or to continuing MDI while waiting 6 months for transmission to CSII. The primary outcomes were patient-reported diabetes-specific health-related quality of life (DHRQOL) and diabetes burden of the main caregiver. Secondary outcomes were caregiver stress, fear of hypoglycemia, satisfaction with treatment, and HbA1c. RESULTS: Two-hundred and eleven patients were randomized between February 2011 and October 2014, and 186 caregivers and 170 patients were analyzed using the intention-to-treat principle for primary outcomes. Children 8 to 11 years in the CSII group reported improved DHRQOL at follow-up compared to MDI (median difference [MD] 9.5, 95% confidence interval [CI] 3.6-16.7, P = 0.004). There were no treatment differences in the adolescent age-group 12 to 16 years (MD 2.7; 95% CI -3.2-9.5; P = 0.353). The main caregivers of the CSII group reported a significant decline of overall diabetes burden at follow-up compared to the MDI group (MD 0; 95% CI -1-0; P = 0.029). Secondary PROs also were in favor of CSII. CONCLUSIONS: CSII has substantial psychosocial benefits. PROs demonstrate these benefits. Registered as NCT01338922 at clinicaltrials.gov.

Continuous glucose monitoring in children, adolescents, and adults with type 1 diabetes mellitus: analysis from the prospective DPV diabetes documentation and quality management system from Germany and Austria.

OBJECTIVE: To determine frequency, duration, and relationship of continuous glucose monitoring (CGM) to glycemic control and rate of hypoglycemia in children and adults in Germany and Austria. RESEARCH DESIGN AND METHODS: From 59,920 patients documented in the DPV (Diabetessoftware zur prospektiven Verlaufsdokumentation) database, 144,385 sensor days of 2874 patients using CGM between January 2008 and September 2010 were analyzed. RESULTS: Overall, 4.8% of patients used CGM. In pediatric patients, study period (p = 0.0309), age (p = 0.0140), insulin dose (p < 0.0001), and use of insulin analogs (p < 0.0001) significantly influenced hemoglobin A1c (HbA1c), but duration of diabetes, sex, and CGM use did not. In contrast, adults with longer CGM use (>30 d) had significantly lower HbA1c (p < 0.0016). Severe hypoglycemia was not reduced in patients using CGM for <30 d. CONCLUSIONS: CGM is still rarely used in Germany and Austria. CGM use is associated with a significant reduction of HbA1c in adults but not in children. Hypoglycemic events were not reduced, irrespective of age.