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

• Status: Recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

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).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institut de Recherches Cliniques de Montreal
• Treatments: Insulin

Criteria

Inclusion Criteria:

1. Males and females ≥ 18 years old

2. Clinical diagnosis of type 1 diabetes for at least one year

3. Treatment with multiple daily insulin injections or insulin pump therapy with insulin analogs (rapid, ultra-rapid and basal insulin)

4. A glycated hemoglobin A1c ≤ 10%

Exclusion Criteria:

1. Clinically significant microvascular complications: nephropathy (eGFR < 40 ml/min), severe proliferative retinopathy as judged by the investigator, neuropathy (particularly diagnosed gastroparesis)

2. Recent (< 3 months) acute macrovascular event (e.g., acute coronary syndrome or cardiac surgery)

3. Known significant cardiac rhythm abnormality based on investigator's judgement

4. Known significant neurological abnormality (e.g., seizure disorder) based on investigator's judgement

5. Ongoing pregnancy or breastfeeding

6. Severe hypoglycemia episode within 1 month of screening

7. Known uncorrected hypokalemia within the past 3 months (potassium < 3.5 mmol/L)