Treatment of Hypoglycemia in Type 1 Diabetes

Institut de Recherches Cliniques de Montreal

Status: Completed

Conditions: Type 1 Diabetes

Treatments: Other: Induced-hypoglycemia test

Study type: Interventional

Funder types: Other

Identifiers

NCT03489967

HYPO-T

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 secondary to the DCCT trial and with insulin formulations with largely different pharmacokinetic profiles from current insulin analogs. Recent studies suggest that with current insulin analogs and intensive therapeutic approach, 15g of carbohydrates may be insufficient to rapidly correct an important proportion of hypoglycemic episodes. It is thus important to determine if the recommended hypoglycemia treatment remains the recommendation.

Enrollment: 29 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Males and females ≥ 18 years of old.
2. Clinical diagnosis of type 1 diabetes for at least one year.
3. Treatment with multiple daily insulin injections or insulin pump therapy and using insulin analogs (rapid, ultra-rapid and basal).
4. HbA1c ≤ 10%.

Exclusion criteria

1. Clinically significant microvascular complications: nephropathy (estimated glomerular filtration rate below 40 ml/min), neuropathy (especially diagnosed gastroparesis) or severe proliferative retinopathy as judged by the investigator.
2. Recent (< 3 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
3. Known significant cardiac rhythm abnormality based on investigator judgment.
4. Abnormal blood panel and/or anemia (Hb < 100g/L).
5. Ongoing pregnancy or breastfeeding.
6. Severe hypoglycemic episode within 1 month of screening.
7. Known uncorrected hypokalemia (potassium < 3.5 mmol/L; available within the past 3 months).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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29 participants in 4 patient groups

16g of carbohydrates - Glucose levels < 3.0 mmol/L

Active Comparator group

Description:

Hypoglycemia treatment with 16g of carbohydrates will be given when glucose levels are below 3.0 mmol/L.

Treatment:

Other: Induced-hypoglycemia test

16g of carbohydrates - Glucose levels 3.0-3.5 mmol/L

Active Comparator group

Description:

Hypoglycemia treatment with 16g of carbohydrates will be given when glucose levels are between 3.0 and 3.5 mmol/L.

Treatment:

Other: Induced-hypoglycemia test

32g of carbohydrates - Glucose levels < 3.0 mmol/L

Active Comparator group

Description:

Hypoglycemia treatment with 32g of carbohydrates will be given when glucose levels are below 3.0 mmol/L

Treatment:

Other: Induced-hypoglycemia test

32g of carbohydrates - Glucose levels 3.0-3.5 mmol/L

Active Comparator group

Description:

Hypoglycemia treatment with 32g of carbohydrates will be given when glucose levels are between 3.0 and 3.5 mmol/L.

Treatment:

Other: Induced-hypoglycemia test