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.

Abstract

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.

• Authors: Gregory P Forlenza, Zoey Li, Bruce A Buckingham, Jordan E Pinsker, Eda Cengiz, R Paul Wadwa, Laya Ekhlaspour, Mei Mei Church, Stuart A Weinzimer, Emily Jost, Tatiana Marcal, Camille Andre, Lori Carria, Vance Swanson, John W Lum, Craig Kollman, William Woodall, Roy W Beck
• Journal: Diabetes care (Diabetes Care) Vol. 41 Issue 10 Pg. 2155-2161 (10 2018) ISSN: 1935-5548 [Electronic] United States
• PMID: 30089663 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © 2018 by the American Diabetes Association.

Chemical References

• Blood Glucose
• Hypoglycemic Agents
• Insulin

Topics

• Adolescent
• Adult
• Aged
• Algorithms
• Blood Glucose (analysis)
• Blood Glucose Self-Monitoring (methods)
• Child
• Cross-Over Studies
• Diabetes Mellitus, Type 1 (blood, diagnosis, drug therapy)
• Drug Delivery Systems
• Female
• Humans
• Hypoglycemia (blood, chemically induced, prevention & control)
• Hypoglycemic Agents (administration & dosage)
• Insulin (administration & dosage)
• Insulin Infusion Systems
• Male
• Middle Aged
• Monitoring, Ambulatory
• Young Adult