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

NCT ID: NCT04876079

Last Updated: 2023-08-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-01
• Study Completion Date: 2023-06-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

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

Group Type: ACTIVE_COMPARATOR

Test to induce a decline in plasma glucose

Intervention Type: OTHER

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.

Dexcom G6

Intervention Type: DEVICE

Participants will have to wear a Dexcom G6 during study interventions

Dex4

Intervention Type: OTHER

When the glycemic threshold is reach, participants will be given 16g of Dex4

Insulin

Intervention Type: DRUG

A subcutaneous insulin bolus will be given to induce a decline in plasma glucose and reach the glycemic threshold.

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

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

Group Type: ACTIVE_COMPARATOR

Test to induce a decline in plasma glucose

Intervention Type: OTHER

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.

Dexcom G6

Intervention Type: DEVICE

Participants will have to wear a Dexcom G6 during study interventions

Dex4

Intervention Type: OTHER

When the glycemic threshold is reach, participants will be given 16g of Dex4

Insulin

Intervention Type: DRUG

A subcutaneous insulin bolus will be given to induce a decline in plasma glucose and reach the glycemic threshold.

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

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

Group Type: ACTIVE_COMPARATOR

Test to induce a decline in plasma glucose

Intervention Type: OTHER

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.

Dexcom G6

Intervention Type: DEVICE

Participants will have to wear a Dexcom G6 during study interventions

Dex4

Intervention Type: OTHER

When the glycemic threshold is reach, participants will be given 16g of Dex4

Insulin

Intervention Type: DRUG

A subcutaneous insulin bolus will be given to induce a decline in plasma glucose and reach the glycemic threshold.

Interventions

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.

Intervention Type: OTHER

Dexcom G6

Participants will have to wear a Dexcom G6 during study interventions

Intervention Type: DEVICE

Dex4

When the glycemic threshold is reach, participants will be given 16g of Dex4

Intervention Type: OTHER

Insulin

A subcutaneous insulin bolus will be given to induce a decline in plasma glucose and reach the glycemic threshold.

Intervention Type: DRUG

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut de Recherches Cliniques de Montreal

OTHER

Sponsor Role: lead

Responsible Party

Rémi Rabasa-Lhoret

Full professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rémi Rabasa-Lhoret

Role: PRINCIPAL_INVESTIGATOR

Institut de recherches cliniques de Montréal

Locations

Montreal Clinical Research Institute

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

2022-1119

Identifier Type: -

Identifier Source: org_study_id