Treatment of Hypoglycemia in Type 1 Diabetes

Type 1 Diabetes Clinical Trial

Official title:

Treatment of Mild-to-moderate Hypoglycemia in Adults With Type 1 Diabetes: a Validation Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03489967
• Other study ID #: HYPO-T
• Status: Completed
• Phase: N/A
• Start date: April 18, 2018
• Est. completion date: August 31, 2020

Study information

• Verified date: September 2020
• Source: Institut de Recherches Cliniques de Montreal
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: August 31, 2020
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Hypoglycemia
• Type 1 Diabetes

Intervention

Other:
• Induced-hypoglycemia test
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 induce hypoglycemia. Oral treatment (16g of carbohydrates or 32g of carbohydrates) will be given when plasma glucose levels are at the target threshold of < 3.0 mmol/L or 3.0-3.5 mmol/L. Hypoglycemia symptoms will be assessed every 10 minutes by the participant using a validated scale starting from the time of insulin bolus until hypoglycemia recovery. One hour after hypoglycemia recovery, a standardized meal will be given.

Locations

Country	Name	City	State
Canada	Institut de recherches cliniques de Montréal	Montréal

Sponsors (1)

Lead Sponsor	Collaborator
Institut de Recherches Cliniques de Montreal

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in glucose levels 15 minutes after hypoglycemic treatment	Change in glucose levels 15 minutes after hypoglycemic treatment (16g vs. 32g of carbohydrates) when glucose levels at the time of treatment are below 3.0 mmol/L or between 3.0 and 3.5 mmol/L.	15 minutes after hypoglycemic treatment
Secondary	Change in glucose levels 20 minutes after hypoglycemic treatment	Change in glucose levels 20 minutes after hypoglycemic treatment (16g vs. 32g of carbohydrates) when glucose levels at the time of treatment are below 3.0 mmol/L or between 3.0 and 3.5 mmol/L.	20 minutes after hypoglycemic treatment
Secondary	Change in glucose levels 30 minutes after hypoglycemic treatment	Change in glucose levels 30 minutes after hypoglycemic treatment (16g vs. 32g of carbohydrates) when glucose levels at the time of treatment are below 3.0 mmol/L or between 3.0 and 3.5 mmol/L.	30 minutes after hypoglycemic treatment
Secondary	Change in glucose levels 45 minutes after hypoglycemic treatment	Change in glucose levels 45 minutes after hypoglycemic treatment (16g vs. 32g of carbohydrates) when glucose levels at the time of treatment are below 3.0 mmol/L or between 3.0 and 3.5 mmol/L.	45 minutes after hypoglycemic treatment
Secondary	Change in glucose levels 60 minutes after hypoglycemic treatment	Change in glucose levels 60 minutes after hypoglycemic treatment (16g vs. 32g of carbohydrates) when glucose levels at the time of treatment are below 3.0 mmol/L or between 3.0 and 3.5 mmol/L.	60 minutes after hypoglycemic treatment
Secondary	Number of participants with glucose levels above 8.0 mmol/L 1 hour after hypoglycemia correction		60 minutes after hypoglycemia correction
Secondary	Number of participants with glucose levels above 10.0 mmol/L 1 hour after hypoglycemia correction		60 minutes after hypoglycemia correction
Secondary	Glucose levels 60 minutes after meal consumption		60 minutes after meal consumption
Secondary	Glucose levels 90 minutes after meal consumption		90 minutes after meal consumption
Secondary	Number of patients for whom hypoglycemia was corrected 10 minutes after hypoglycemic treatment		10 minutes after hypoglycemic treatment
Secondary	Number of patients for whom hypoglycemia was corrected 15 minutes after hypoglycemic treatment		15 minutes after hypoglycemic treatment
Secondary	Number of patients for whom hypoglycemia was corrected 20 minutes after hypoglycemic treatment		20 minutes after hypoglycemic treatment
Secondary	Number of patients for whom hypoglycemia was corrected 25 minutes after hypoglycemic treatment		25 minutes after hypoglycemic treatment
Secondary	Number of patients for whom hypoglycemia was corrected 30 minutes after hypoglycemic treatment		30 minutes after hypoglycemic treatment
Secondary	Number of patients for whom hypoglycemia was corrected 35 minutes after hypoglycemic treatment		35 minutes after hypoglycemic treatment
Secondary	Number of hypoglycemic events corrected 10 minutes after hypoglycemic treatment		10 minutes after hypoglycemic treatment
Secondary	Number of hypoglycemic events corrected 15 minutes after hypoglycemic treatment		15 minutes after hypoglycemic treatment
Secondary	Number of hypoglycemic events corrected 20 minutes after hypoglycemic treatment		20 minutes after hypoglycemic treatment
Secondary	Number of hypoglycemic events corrected 25 minutes after hypoglycemic treatment		25 minutes after hypoglycemic treatment
Secondary	Number of hypoglycemic events corrected 30 minutes after hypoglycemic treatment		30 minutes after hypoglycemic treatment
Secondary	Number of hypoglycemic events corrected 35 minutes after hypoglycemic treatment		35 minutes after hypoglycemic treatment
Secondary	Number of patients for whom hypoglycemia symptoms disappeared 10 minutes after hypoglycemic treatment		10 minutes after hypoglycemic treatment
Secondary	Number of patients for whom hypoglycemia symptoms disappeared 15 minutes after hypoglycemic treatment		15 minutes after hypoglycemic treatment
Secondary	Number of patients for whom hypoglycemia symptoms disappeared 20 minutes after hypoglycemic treatment		20 minutes after hypoglycemic treatment
Secondary	Number of patients for whom hypoglycemia symptoms disappeared 25 minutes after hypoglycemic treatment		25 minutes after hypoglycemic treatment
Secondary	Number of patients for whom hypoglycemia symptoms disappeared 30 minutes after hypoglycemic treatment		30 minutes after hypoglycemic treatment
Secondary	Number of patients for whom hypoglycemia symptoms disappeared 35 minutes after hypoglycemic treatment		35 minutes after hypoglycemic treatment
Secondary	Number of patients requiring a second treatment 40 minutes after the first hypoglycemic treatment		40 minutes after the first hypoglycemic treatment
Secondary	Number of patients requiring a second treatment 15 minutes after the first hypoglycemic treatment		15 minutes after the first hypoglycemic treatment