Prevention of Mild-to-moderate Hypoglycemia in Type 1 Diabetes

Type 1 Diabetes Clinical Trial

— REVERSIBLE  

Official title:

Towards Prevention of Mild-to-moderate Hypoglycemia in Type 1 Diabetes With Oral Glucose at a Higher Blood Glucose Threshold

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04876079
• Other study ID #: 2022-1119
• Status: Completed
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: June 30, 2023

Study information

• Verified date: August 2023
• 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. 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 30, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Males and females = 18 years old

2. Clinical diagnosis of type 1 diabetes for at least one year

3. Treatment with multiple daily insulin injections or insulin pump therapy with insulin analogs (rapid, ultra-rapid and basal insulin)

4. A glycated hemoglobin A1c = 10%

Exclusion Criteria:

1. Clinically significant microvascular complications: nephropathy (eGFR < 40 ml/min), severe proliferative retinopathy as judged by the investigator, neuropathy (particularly diagnosed gastroparesis)

2. Recent (< 3 months) acute macrovascular event (e.g., acute coronary syndrome or cardiac surgery)

3. Known significant cardiac rhythm abnormality based on investigator's judgement

4. Known significant neurological abnormality (e.g., seizure disorder) based on investigator's judgement

5. Ongoing pregnancy or breastfeeding

6. Severe hypoglycemia episode within 1 month of screening

7. Known uncorrected hypokalemia within the past 3 months (potassium < 3.5 mmol/L)

Related Conditions & MeSH terms

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

Intervention

Other:
• Test to induce a decline in plasma glucose
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.

Device:
• Dexcom G6
Participants will have to wear a Dexcom G6 during study interventions

Other:
• Dex4
When the glycemic threshold is reach, participants will be given 16g of Dex4

Drug:
• Insulin
A subcutaneous insulin bolus will be given to induce a decline in plasma glucose and reach the glycemic threshold.

Locations

Country	Name	City	State
Canada	Montreal Clinical Research Institute	Montreal	Quebec

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	Time spent of glucose levels < 4.0 mmol/L		60 minutes after carbohydrates consumption
Secondary	Plasma glucose levels at 5 minutes after carbohydrates consumption		5 minutes after carbohydrates consumption
Secondary	Plasma glucose levels at 10 minutes after carbohydrates consumption		10 minutes after carbohydrates consumption
Secondary	Plasma glucose levels at 15 minutes after carbohydrates consumption		15 minutes after carbohydrates consumption
Secondary	Plasma glucose levels at 20 minutes after carbohydrates consumption		20 minutes after carbohydrates consumption
Secondary	Plasma glucose levels at 30 minutes after carbohydrates consumption		30 minutes after carbohydrates consumption
Secondary	Plasma glucose levels at 45 minutes after carbohydrates consumption		45 minutes after carbohydrates consumption
Secondary	Plasma glucose levels at 60 minutes after carbohydrates consumption		60 minutes after carbohydrates consumption
Secondary	Lowest plasma glucose level eached after CHO consumption		60 minutes after carbohydrates consumption
Secondary	Time from CHO consumption to the lowest plasma glucose level reached		60 minutes after carbohydrates consumption
Secondary	Time from CHO consumption to plasma glucose < 3.5 mmol/L		60 minutes after carbohydrates consumption
Secondary	Percentage of participants reaching hypoglycemia (< 4.0 mmol/L) after CHO consumption		60 minutes after carbohydrates consumption
Secondary	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	10 minutes after carbohydrates consumption
Secondary	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	15 minutes after carbohydrates consumption
Secondary	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	20 minutes after carbohydrates consumption
Secondary	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	25 minutes after carbohydrates consumption
Secondary	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	30 minutes after carbohydrates consumption
Secondary	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	35 minutes after carbohydrates consumption
Secondary	Percentage of hypoglycemic events that were corrected at 10 minutes after CHO consumption	Only calculated for events with glucose level < 4.0 mmol/L	10 minutes after carbohydrates consumption
Secondary	Percentage of hypoglycemic events that were corrected at 15 minutes after CHO consumption	Only calculated for events with glucose level < 4.0 mmol/L	15 minutes after carbohydrates consumption
Secondary	Percentage of hypoglycemic events that were corrected at 20 minutes after CHO consumption	Only calculated for events with glucose level < 4.0 mmol/L	20 minutes after carbohydrates consumption
Secondary	Percentage of hypoglycemic events that were corrected at 25 minutes after CHO consumption	Only calculated for events with glucose level < 4.0 mmol/L	25 minutes after carbohydrates consumption
Secondary	Percentage of hypoglycemic events that were corrected at 30 minutes after CHO consumption	Only calculated for events with glucose level < 4.0 mmol/L	30 minutes after carbohydrates consumption
Secondary	Percentage of hypoglycemic events that were corrected at 35 minutes after CHO consumption	Only calculated for events with glucose level < 4.0 mmol/L	35 minutes after carbohydrates consumption
Secondary	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	20 minutes after carbohydrates consumption
Secondary	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	40 minutes after carbohydrates consumption
Secondary	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	60 minutes after carbohydrates consumption
Secondary	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