Overnight Glucose Control With an Automated, Unified Safety System in Children and Adolescents With Type 1 Diabetes at Diabetes Camp

• Published in: Diabetes care Vol. 37; no. 8; pp. 2310 - 2316
• Main Authors: Ly, Trang T., Breton, Marc D., Keith-Hynes, Patrick, De Salvo, Daniel, Clinton, Paula, Benassi, Kari, Mize, Benton, Chernavvsky, Daniel, Place, Jéróme, Wilson, Darrell M., Kovatchev, Boris P., Buckingham, Bruce A.
• Format: Journal Article
• Language: English
• Published: Alexandria, VA American Diabetes Association 01.08.2014
• Subjects: Adolescent; Adult; Algorithms; Automation; Biological and medical sciences; Biosensing Techniques - instrumentation; Blood Glucose - drug effects; Blood Glucose - metabolism; Blood Glucose Self-Monitoring - instrumentation; Camping; Child; Children & youth; Circadian Rhythm; Diabetes; Diabetes Mellitus, Type 1 - blood; Diabetes Mellitus, Type 1 - drug therapy; Diabetes Mellitus, Type 1 - epidemiology; Diabetes. Impaired glucose tolerance; Emerging Technologies and Therapeutics; Endocrine pancreas. Apud cells (diseases); Endocrinopathies; Etiopathogenesis. Screening. Investigations. Target tissue resistance; Female; General aspects; Glucose; Humans; Hypoglycemic Agents - administration & dosage; Hypoglycemic Agents - adverse effects; Insulin - administration & dosage; Insulin - adverse effects; Insulin Infusion Systems - adverse effects; Intention to Treat Analysis; Male; Median; Medical sciences; Metabolic diseases; Protocol; Teenagers; Young Adult; Endocrinopathy; Human; Immunopathology; Nutrition; Toxicity; Autoimmune disease; Metabolic diseases; Glucose; Surveillance; Type 1 diabetes; Adolescent; Safety; Therapeutic camp; Child; Endocrinology
• ISSN: 0149-5992; 1935-5548; 1935-5548
• DOI: 10.2337/dc14-0147

To determine the safety and efficacy of an automated unified safety system (USS) in providing overnight closed-loop (OCL) control in children and adolescents with type 1 diabetes attending diabetes summer camps. The Diabetes Assistant (DIAS) USS used the Dexcom G4 Platinum glucose sensor (Dexcom) and t:slim insulin pump (Tandem Diabetes Care). An initial inpatient study was completed for 12 participants to evaluate safety. For the main camp study, 20 participants with type 1 diabetes were randomized to either OCL or sensor-augmented therapy (control conditions) per night over the course of a 5- to 6-day diabetes camp. Subjects completed 54 OCL nights and 52 control nights. On an intention-to-treat basis, with glucose data analyzed regardless of system status, the median percent time in range, from 70-150 mg/dL, was 62% (29, 87) for OCL nights versus 55% (25, 80) for sensor-augmented pump therapy (P = 0.233). A per-protocol analysis allowed for assessment of algorithm performance. The median percent time in range, from 70-150 mg/dL, was 73% (50, 89) for OCL nights (n = 41) versus 52% (24, 83) for control conditions (n = 39) (P = 0.037). There was less time spent in the hypoglycemic range <50, <60, and <70 mg/dL during OCL compared with the control period (P = 0.019, P = 0.009, and P = 0.023, respectively). The DIAS USS algorithm is effective in improving time spent in range as well as reducing nocturnal hypoglycemia during the overnight period in children and adolescents with type 1 diabetes in a diabetes camp setting.