Prevention of Mild-to-moderate Hypoglycemia in Type 1 Diabetes (REVERSIBLE)

Institut de Recherches Cliniques de Montreal

Status: Completed

Conditions: Type 1 Diabetes

Treatments: Drug: Insulin; Other: Test to induce a decline in plasma glucose; Other: Dex4; Device: Dexcom G6

Study type: Interventional

Funder types: Other

Identifiers

NCT04876079

2022-1119

Details and patient eligibility

About

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).

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

16g of carbohydrates - Plasma glucose < 4.0 mmol/L

Active Comparator group

Description:

16g of carbohydrates will be given when glucose levels are below 4.0 mmol/L (management per guidelines)

Treatment:

Device: Dexcom G6

Drug: Insulin

Other: Test to induce a decline in plasma glucose

Other: Dex4

16g of carbohydrates - Plasma glucose ≤ 4.5 mmol/L

Active Comparator group

Description:

16g of carbohydrates will be given when glucose levels are equal or below 4.5 mmol/L.

Treatment:

Device: Dexcom G6

Drug: Insulin

Other: Test to induce a decline in plasma glucose

Other: Dex4

16g of carbohydrates - Plasma glucose ≤ 5.0 mmol/L

Active Comparator group

Description:

16g of carbohydrates will be given when glucose levels are equal or below 5.0 mmol/L.

Treatment:

Device: Dexcom G6

Drug: Insulin

Other: Test to induce a decline in plasma glucose

Other: Dex4