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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
29
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.
Institut de recherches cliniques de Montréal
Montreal, Canada
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.
Time frame: 15 minutes after hypoglycemic treatment
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.
Time frame: 20 minutes after hypoglycemic treatment
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.
Time frame: 30 minutes after hypoglycemic treatment
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.
Time frame: 45 minutes after hypoglycemic treatment
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.
Time frame: 60 minutes after hypoglycemic treatment
Number of participants with glucose levels above 8.0 mmol/L 1 hour after hypoglycemia correction
Time frame: 60 minutes after hypoglycemia correction
Number of participants with glucose levels above 10.0 mmol/L 1 hour after hypoglycemia correction
Time frame: 60 minutes after hypoglycemia correction
Glucose levels 60 minutes after meal consumption
Time frame: 60 minutes after meal consumption
Glucose levels 90 minutes after meal consumption
Time frame: 90 minutes after meal consumption
Number of patients for whom hypoglycemia was corrected 10 minutes after hypoglycemic treatment
Time frame: 10 minutes after hypoglycemic treatment
Number of patients for whom hypoglycemia was corrected 15 minutes after hypoglycemic treatment
Time frame: 15 minutes after hypoglycemic treatment
Number of patients for whom hypoglycemia was corrected 20 minutes after hypoglycemic treatment
Time frame: 20 minutes after hypoglycemic treatment
Number of patients for whom hypoglycemia was corrected 25 minutes after hypoglycemic treatment
Time frame: 25 minutes after hypoglycemic treatment
Number of patients for whom hypoglycemia was corrected 30 minutes after hypoglycemic treatment
Time frame: 30 minutes after hypoglycemic treatment
Number of patients for whom hypoglycemia was corrected 35 minutes after hypoglycemic treatment
Time frame: 35 minutes after hypoglycemic treatment
Number of hypoglycemic events corrected 10 minutes after hypoglycemic treatment
Time frame: 10 minutes after hypoglycemic treatment
Number of hypoglycemic events corrected 15 minutes after hypoglycemic treatment
Time frame: 15 minutes after hypoglycemic treatment
Number of hypoglycemic events corrected 20 minutes after hypoglycemic treatment
Time frame: 20 minutes after hypoglycemic treatment
Number of hypoglycemic events corrected 25 minutes after hypoglycemic treatment
Time frame: 25 minutes after hypoglycemic treatment
Number of hypoglycemic events corrected 30 minutes after hypoglycemic treatment
Time frame: 30 minutes after hypoglycemic treatment
Number of hypoglycemic events corrected 35 minutes after hypoglycemic treatment
Time frame: 35 minutes after hypoglycemic treatment
Number of patients for whom hypoglycemia symptoms disappeared 10 minutes after hypoglycemic treatment
Time frame: 10 minutes after hypoglycemic treatment
Number of patients for whom hypoglycemia symptoms disappeared 15 minutes after hypoglycemic treatment
Time frame: 15 minutes after hypoglycemic treatment
Number of patients for whom hypoglycemia symptoms disappeared 20 minutes after hypoglycemic treatment
Time frame: 20 minutes after hypoglycemic treatment
Number of patients for whom hypoglycemia symptoms disappeared 25 minutes after hypoglycemic treatment
Time frame: 25 minutes after hypoglycemic treatment
Number of patients for whom hypoglycemia symptoms disappeared 30 minutes after hypoglycemic treatment
Time frame: 30 minutes after hypoglycemic treatment
Number of patients for whom hypoglycemia symptoms disappeared 35 minutes after hypoglycemic treatment
Time frame: 35 minutes after hypoglycemic treatment
Number of patients requiring a second treatment 40 minutes after the first hypoglycemic treatment
Time frame: 40 minutes after the first hypoglycemic treatment
Number of patients requiring a second treatment 15 minutes after the first hypoglycemic treatment
Time frame: 15 minutes after the first hypoglycemic treatment
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