NCT04876079

Prevention of Mild-to-moderate Hypoglycemia in Type 1 Diabetes

Towards Prevention of Mild-to-moderate Hypoglycemia in Type 1 Diabetes With Oral Glucose at a Higher Blood Glucose Threshold

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Institut de Recherches Cliniques de Montreal · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

According to guidelines, when a mild-to-moderate hypoglycemia occurs (capillary blood glucose \< 4.0 mmol/L), 15-20g of rapidly absorbed carbohydrates should be ingested. Patients should re-test and re-ingest 15-20g carbohydrates every 15 minutes until they recover from hypoglycemia. These recommendations were principally based on two studies conducted in the 80s before the introduction of intensive insulin therapy. In practice, only 32-50% of patients follow the current guidelines. In addition, recent studies suggest that under current intensive insulin therapies, an initial correction with 15g of oral glucose may be insufficient to rapidly correct mild-to-moderate hypoglycemia. With the development and increasing usage of newer glucose monitoring technologies, the community is witnessing a shift in hypoglycemia management, from a reactive to a proactive approach (e.g., prevent imminent episodes rather than treating established episodes).

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
OTHER	Test to induce a decline in plasma glucose	Participants will be admitted at the research center at 7:00 after an overnight fast. A venous catheter will be inserted into an arm vein for blood sampling purposes. A subcutaneous insulin bolus will be administered to bring plasma glucose to the glycemic threshold. Oral carbohydrates (16g) will be given when plasma glucose levels are at the target threshold. Sixty minutes after carbohydrates consumption, a standardized meal will be provided and participants will be discharged 90 minutes after the meal.
DEVICE	Dexcom G6	Participants will have to wear a Dexcom G6 during study interventions
OTHER	Dex4	When the glycemic threshold is reach, participants will be given 16g of Dex4
DRUG	Insulin	A subcutaneous insulin bolus will be given to induce a decline in plasma glucose and reach the glycemic threshold.

Timeline

• Start date: 2021-06-01
• Primary completion: 2023-06-01
• Completion: 2023-06-30
• First posted: 2021-05-06
• Last updated: 2026-03-05

Locations

1 site across 1 country: Canada