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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
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.
Participants will have to wear a Dexcom G6 during study interventions
When the glycemic threshold is reach, participants will be given 16g of Dex4
A subcutaneous insulin bolus will be given to induce a decline in plasma glucose and reach the glycemic threshold.
Montreal Clinical Research Institute
Montreal, Quebec, Canada
Time spent of glucose levels < 4.0 mmol/L
Time frame: 60 minutes after carbohydrates consumption
Plasma glucose levels at 5 minutes after carbohydrates consumption
Time frame: 5 minutes after carbohydrates consumption
Plasma glucose levels at 10 minutes after carbohydrates consumption
Time frame: 10 minutes after carbohydrates consumption
Plasma glucose levels at 15 minutes after carbohydrates consumption
Time frame: 15 minutes after carbohydrates consumption
Plasma glucose levels at 20 minutes after carbohydrates consumption
Time frame: 20 minutes after carbohydrates consumption
Plasma glucose levels at 30 minutes after carbohydrates consumption
Time frame: 30 minutes after carbohydrates consumption
Plasma glucose levels at 45 minutes after carbohydrates consumption
Time frame: 45 minutes after carbohydrates consumption
Plasma glucose levels at 60 minutes after carbohydrates consumption
Time frame: 60 minutes after carbohydrates consumption
Lowest plasma glucose level eached after CHO consumption
Time frame: 60 minutes after carbohydrates consumption
Time from CHO consumption to the lowest plasma glucose level reached
Time frame: 60 minutes after carbohydrates consumption
Time from CHO consumption to plasma glucose < 3.5 mmol/L
Time frame: 60 minutes after carbohydrates consumption
Percentage of participants reaching hypoglycemia (< 4.0 mmol/L) after CHO consumption
Time frame: 60 minutes after carbohydrates consumption
Percentage of participants for whom hypoglycemia was corrected at 10 minutes after CHO consumption
Only calculated for participants who will have glucose levels \< 4.0 mmol/L
Time frame: 10 minutes after carbohydrates consumption
Percentage of participants for whom hypoglycemia was corrected at 15 minutes after CHO consumption
Only calculated for participants who will have glucose levels \< 4.0 mmol/L
Time frame: 15 minutes after carbohydrates consumption
Percentage of participants for whom hypoglycemia was corrected at 20 minutes after CHO consumption
Only calculated for participants who will have glucose levels \< 4.0 mmol/L
Time frame: 20 minutes after carbohydrates consumption
Percentage of participants for whom hypoglycemia was corrected at 25 minutes after CHO consumption
Only calculated for participants who will have glucose levels \< 4.0 mmol/L
Time frame: 25 minutes after carbohydrates consumption
Percentage of participants for whom hypoglycemia was corrected at 30 minutes after CHO consumption
Only calculated for participants who will have glucose levels \< 4.0 mmol/L
Time frame: 30 minutes after carbohydrates consumption
Percentage of participants for whom hypoglycemia was corrected at 35 minutes after CHO consumption
Only calculated for participants who will have glucose levels \< 4.0 mmol/L
Time frame: 35 minutes after carbohydrates consumption
Percentage of hypoglycemic events that were corrected at 10 minutes after CHO consumption
Only calculated for events with glucose level \< 4.0 mmol/L
Time frame: 10 minutes after carbohydrates consumption
Percentage of hypoglycemic events that were corrected at 15 minutes after CHO consumption
Only calculated for events with glucose level \< 4.0 mmol/L
Time frame: 15 minutes after carbohydrates consumption
Percentage of hypoglycemic events that were corrected at 20 minutes after CHO consumption
Only calculated for events with glucose level \< 4.0 mmol/L
Time frame: 20 minutes after carbohydrates consumption
Percentage of hypoglycemic events that were corrected at 25 minutes after CHO consumption
Only calculated for events with glucose level \< 4.0 mmol/L
Time frame: 25 minutes after carbohydrates consumption
Percentage of hypoglycemic events that were corrected at 30 minutes after CHO consumption
Only calculated for events with glucose level \< 4.0 mmol/L
Time frame: 30 minutes after carbohydrates consumption
Percentage of hypoglycemic events that were corrected at 35 minutes after CHO consumption
Only calculated for events with glucose level \< 4.0 mmol/L
Time frame: 35 minutes after carbohydrates consumption
Percentage of participants requiring a second treatment with carbohydrates at 20 minutes after the first CHO consumption
Only calculated for participants who will have glucose levels \< 4.0 mmol/L
Time frame: 20 minutes after carbohydrates consumption
Percentage of participants requiring a second treatment with carbohydrates at 40 minutes after the first CHO consumption
Only calculated for participants who will have glucose levels \< 4.0 mmol/L
Time frame: 40 minutes after carbohydrates consumption
Percentage of participants requiring a second treatment with carbohydrates at 60 minutes after the first CHO consumption
Only calculated for participants who will have glucose levels \< 4.0 mmol/L
Time frame: 60 minutes after carbohydrates consumption
Percentage of participants experiencing a rebound hyperglycemia (≥ 10.0 mmol/L) within the first hour following the first carbobydrates consumption
Time frame: 60 minutes after carbohydrates consumption
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