Prevention of Mild-to-moderate Hypoglycemia in Type 1 Diabetes
- Conditions
- Type 1 Diabetes
- Interventions
- Registration Number
- NCT04876079
- Lead Sponsor
- Institut de Recherches Cliniques de Montreal
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- Males and females ≥ 18 years old
- Clinical diagnosis of type 1 diabetes for at least one year
- Treatment with multiple daily insulin injections or insulin pump therapy with insulin analogs (rapid, ultra-rapid and basal insulin)
- A glycated hemoglobin A1c ≤ 10%
- Clinically significant microvascular complications: nephropathy (eGFR < 40 ml/min), severe proliferative retinopathy as judged by the investigator, neuropathy (particularly diagnosed gastroparesis)
- Recent (< 3 months) acute macrovascular event (e.g., acute coronary syndrome or cardiac surgery)
- Known significant cardiac rhythm abnormality based on investigator's judgement
- Known significant neurological abnormality (e.g., seizure disorder) based on investigator's judgement
- Ongoing pregnancy or breastfeeding
- Severe hypoglycemia episode within 1 month of screening
- Known uncorrected hypokalemia within the past 3 months (potassium < 3.5 mmol/L)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 16g of carbohydrates - Plasma glucose ≤ 4.5 mmol/L Dex4 16g of carbohydrates will be given when glucose levels are equal or below 4.5 mmol/L. 16g of carbohydrates - Plasma glucose ≤ 4.5 mmol/L Dexcom G6 16g of carbohydrates will be given when glucose levels are equal or below 4.5 mmol/L. 16g of carbohydrates - Plasma glucose ≤ 4.5 mmol/L Insulin 16g of carbohydrates will be given when glucose levels are equal or below 4.5 mmol/L. 16g of carbohydrates - Plasma glucose ≤ 5.0 mmol/L Test to induce a decline in plasma glucose 16g of carbohydrates will be given when glucose levels are equal or below 5.0 mmol/L. 16g of carbohydrates - Plasma glucose ≤ 4.5 mmol/L Test to induce a decline in plasma glucose 16g of carbohydrates will be given when glucose levels are equal or below 4.5 mmol/L. 16g of carbohydrates - Plasma glucose ≤ 5.0 mmol/L Dex4 16g of carbohydrates will be given when glucose levels are equal or below 5.0 mmol/L. 16g of carbohydrates - Plasma glucose ≤ 5.0 mmol/L Dexcom G6 16g of carbohydrates will be given when glucose levels are equal or below 5.0 mmol/L. 16g of carbohydrates - Plasma glucose < 4.0 mmol/L Test to induce a decline in plasma glucose 16g of carbohydrates will be given when glucose levels are below 4.0 mmol/L (management per guidelines) 16g of carbohydrates - Plasma glucose < 4.0 mmol/L Dexcom G6 16g of carbohydrates will be given when glucose levels are below 4.0 mmol/L (management per guidelines) 16g of carbohydrates - Plasma glucose < 4.0 mmol/L Dex4 16g of carbohydrates will be given when glucose levels are below 4.0 mmol/L (management per guidelines) 16g of carbohydrates - Plasma glucose ≤ 5.0 mmol/L Insulin 16g of carbohydrates will be given when glucose levels are equal or below 5.0 mmol/L. 16g of carbohydrates - Plasma glucose < 4.0 mmol/L Insulin 16g of carbohydrates will be given when glucose levels are below 4.0 mmol/L (management per guidelines)
- Primary Outcome Measures
Name Time Method Time spent of glucose levels < 4.0 mmol/L 60 minutes after carbohydrates consumption
- Secondary Outcome Measures
Name Time Method Plasma glucose levels at 5 minutes after carbohydrates consumption 5 minutes after carbohydrates consumption Plasma glucose levels at 15 minutes after carbohydrates consumption 15 minutes after carbohydrates consumption Plasma glucose levels at 10 minutes after carbohydrates consumption 10 minutes after carbohydrates consumption Plasma glucose levels at 30 minutes after carbohydrates consumption 30 minutes after carbohydrates consumption Percentage of participants for whom hypoglycemia was corrected at 30 minutes after CHO consumption 30 minutes after carbohydrates consumption Only calculated for participants who will have glucose levels \< 4.0 mmol/L
Percentage of participants for whom hypoglycemia was corrected at 35 minutes after CHO consumption 35 minutes after carbohydrates consumption Only calculated for participants who will have glucose levels \< 4.0 mmol/L
Percentage of hypoglycemic events that were corrected at 10 minutes after CHO consumption 10 minutes after carbohydrates consumption Only calculated for events with glucose level \< 4.0 mmol/L
Percentage of hypoglycemic events that were corrected at 20 minutes after CHO consumption 20 minutes after carbohydrates consumption Only calculated for events with glucose level \< 4.0 mmol/L
Percentage of participants requiring a second treatment with carbohydrates at 20 minutes after the first CHO consumption 20 minutes after carbohydrates consumption Only calculated for participants who will have glucose levels \< 4.0 mmol/L
Plasma glucose levels at 45 minutes after carbohydrates consumption 45 minutes after carbohydrates consumption Time from CHO consumption to the lowest plasma glucose level reached 60 minutes after carbohydrates consumption Plasma glucose levels at 20 minutes after carbohydrates consumption 20 minutes after carbohydrates consumption Plasma glucose levels at 60 minutes after carbohydrates consumption 60 minutes after carbohydrates consumption Lowest plasma glucose level eached after CHO consumption 60 minutes after carbohydrates consumption Time from CHO consumption to plasma glucose < 3.5 mmol/L 60 minutes after carbohydrates consumption Percentage of participants reaching hypoglycemia (< 4.0 mmol/L) after CHO consumption 60 minutes after carbohydrates consumption Percentage of participants for whom hypoglycemia was corrected at 10 minutes after CHO consumption 10 minutes after carbohydrates consumption Only calculated for participants who will have glucose levels \< 4.0 mmol/L
Percentage of participants for whom hypoglycemia was corrected at 15 minutes after CHO consumption 15 minutes after carbohydrates consumption Only calculated for participants who will have glucose levels \< 4.0 mmol/L
Percentage of participants for whom hypoglycemia was corrected at 20 minutes after CHO consumption 20 minutes after carbohydrates consumption Only calculated for participants who will have glucose levels \< 4.0 mmol/L
Percentage of participants for whom hypoglycemia was corrected at 25 minutes after CHO consumption 25 minutes after carbohydrates consumption Only calculated for participants who will have glucose levels \< 4.0 mmol/L
Percentage of hypoglycemic events that were corrected at 15 minutes after CHO consumption 15 minutes after carbohydrates consumption Only calculated for events with glucose level \< 4.0 mmol/L
Percentage of hypoglycemic events that were corrected at 25 minutes after CHO consumption 25 minutes after carbohydrates consumption Only calculated for events with glucose level \< 4.0 mmol/L
Percentage of hypoglycemic events that were corrected at 30 minutes after CHO consumption 30 minutes after carbohydrates consumption Only calculated for events with glucose level \< 4.0 mmol/L
Percentage of hypoglycemic events that were corrected at 35 minutes after CHO consumption 35 minutes after carbohydrates consumption Only calculated for events with glucose level \< 4.0 mmol/L
Percentage of participants requiring a second treatment with carbohydrates at 40 minutes after the first CHO consumption 40 minutes after carbohydrates consumption Only calculated for participants who will have glucose levels \< 4.0 mmol/L
Percentage of participants requiring a second treatment with carbohydrates at 60 minutes after the first CHO consumption 60 minutes after carbohydrates consumption Only calculated for participants who will have glucose levels \< 4.0 mmol/L
Percentage of participants experiencing a rebound hyperglycemia (≥ 10.0 mmol/L) within the first hour following the first carbobydrates consumption 60 minutes after carbohydrates consumption
Trial Locations
- Locations (1)
Montreal Clinical Research Institute
🇨🇦Montreal, Quebec, Canada