NCT02855307

Closed-loop Control of Glucose Levels (Artificial Pancreas) During Postprandial Exercise in Adults With Type 1 Diabetes

A Single-blind, Randomized, Cross-over Study to Assess the Efficacy of Single-hormone Closed-loop Strategy at Preventing Hypoglycemia During Unannounced and Announced Exercise in Adults With Type 1 Diabetes

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Institut de Recherches Cliniques de Montreal · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Regular physical activity is associated with many health benefits for individuals with type 1 diabetes including improved cardiovascular fitness and vascular health, decreased insulin requirements, improved body composition and quality of life. However, exercise-induced hypoglycemia is very frequent and thus is the main limiting factor for physical activity practice in this population. The artificial pancreas is composed of three components: glucose sensor to read glucose levels, insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required insulin dosages based on the sensor's readings. The artificial pancreas has the potential to reduce the risk of exercise-induced hypoglycemia but the importance of announcing exercise to the artificial pancreas is yet to be explored. The objective of this study is to investigate 1) if announcing postprandial exercise to the artificial pancreas is beneficial in reducing the risk of hypoglycemia and 2) if an insulin bolus reduction is necessary when announcing the exercise to the artificial pancreas.

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
OTHER	60-minute exercise	Patients will be admitted at the research clinical facility at 6:30. The artificial pancreas intervention will start at 7:00. A standardized breakfast will be served at 8:00. At 9:30, patients will performed a 60-minute exercise on the ergocycle at 60% of VO2 max. At 11:30, patients will be switched to standard insulin pump therapy and a lunch will be served. Patients will be discharged after lunch consumption.
DEVICE	Insulin pump	Patient's insulin pump will be used to infuse insulin.
DEVICE	Dexcom G4 Platinum glucose sensor	The Dexcom G4 Platinum glucose sensor will be used to measure glucose levels.
DRUG	Insulin	Patient's usual fast-acting insulin analog will be used.
OTHER	Single-hormone closed-loop strategy	Variable subcutaneous insulin infusion rates will be used to regulate glucose levels. Patient's usual fast acting insulin analog (Lispro, Aspart or Guilisine) will be infused using the patient's pump. The glucose level as measured by the real time sensor (Dexcom G4 Platinum, Dexcom Inc.) will be entered manually into the computer every 10 minutes. The pump's infusion rate will then be changed manually based on the computer generated recommendation infusion rates.

Timeline

• Start date: 2016-09-01
• Primary completion: 2018-12-01
• Completion: 2018-12-01
• First posted: 2016-08-04
• Last updated: 2019-02-11

Locations

1 site across 1 country: Canada