Clinical trial NCT04876079: Prevention of Mild-to-moderate Hypoglycemia in Type 1 Diabetes
Official title: Towards Prevention of Mild-to-moderate Hypoglycemia in Type 1 Diabetes With Oral Glucose at a Higher Blood Glucose Threshold
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Keywords: Hypoglycemia
Type 1 diabetes
Carbohydrates
Lead sponsor: Institut de Recherches Cliniques de Montreal
Sponsor class: OTHER
First posted: 2021-05-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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).


Eligibility criteria: 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)

Primary outcomes:
measure: Time spent of glucose levels < 4.0 mmol/L
timeFrame: 60 minutes after carbohydrates consumption
Secondary outcomes:
measure: Plasma glucose levels at 5 minutes after carbohydrates consumption
timeFrame: 5 minutes after carbohydrates consumption
measure: Plasma glucose levels at 10 minutes after carbohydrates consumption
timeFrame: 10 minutes after carbohydrates consumption
measure: Plasma glucose levels at 15 minutes after carbohydrates consumption
timeFrame: 15 minutes after carbohydrates consumption
measure: Plasma glucose levels at 20 minutes after carbohydrates consumption
timeFrame: 20 minutes after carbohydrates consumption
measure: Plasma glucose levels at 30 minutes after carbohydrates consumption
timeFrame: 30 minutes after carbohydrates consumption
measure: Plasma glucose levels at 45 minutes after carbohydrates consumption
timeFrame: 45 minutes after carbohydrates consumption
measure: Plasma glucose levels at 60 minutes after carbohydrates consumption
timeFrame: 60 minutes after carbohydrates consumption
measure: Lowest plasma glucose level eached after CHO consumption
timeFrame: 60 minutes after carbohydrates consumption
measure: Time from CHO consumption to the lowest plasma glucose level reached
timeFrame: 60 minutes after carbohydrates consumption
measure: Time from CHO consumption to plasma glucose < 3.5 mmol/L
timeFrame: 60 minutes after carbohydrates consumption
measure: Percentage of participants reaching hypoglycemia (< 4.0 mmol/L) after CHO consumption
timeFrame: 60 minutes after carbohydrates consumption
measure: Percentage of participants for whom hypoglycemia was corrected at 10 minutes after CHO consumption
timeFrame: 10 minutes after carbohydrates consumption
measure: Percentage of participants for whom hypoglycemia was corrected at 15 minutes after CHO consumption
timeFrame: 15 minutes after carbohydrates consumption
measure: Percentage of participants for whom hypoglycemia was corrected at 20 minutes after CHO consumption
timeFrame: 20 minutes after carbohydrates consumption
measure: Percentage of participants for whom hypoglycemia was corrected at 25 minutes after CHO consumption
timeFrame: 25 minutes after carbohydrates consumption
measure: Percentage of participants for whom hypoglycemia was corrected at 30 minutes after CHO consumption
timeFrame: 30 minutes after carbohydrates consumption
measure: Percentage of participants for whom hypoglycemia was corrected at 35 minutes after CHO consumption
timeFrame: 35 minutes after carbohydrates consumption
measure: Percentage of hypoglycemic events that were corrected at 10 minutes after CHO consumption
timeFrame: 10 minutes after carbohydrates consumption
measure: Percentage of hypoglycemic events that were corrected at 15 minutes after CHO consumption
timeFrame: 15 minutes after carbohydrates consumption
measure: Percentage of hypoglycemic events that were corrected at 20 minutes after CHO consumption
timeFrame: 20 minutes after carbohydrates consumption
measure: Percentage of hypoglycemic events that were corrected at 25 minutes after CHO consumption
timeFrame: 25 minutes after carbohydrates consumption
measure: Percentage of hypoglycemic events that were corrected at 30 minutes after CHO consumption
timeFrame: 30 minutes after carbohydrates consumption
measure: Percentage of hypoglycemic events that were corrected at 35 minutes after CHO consumption
timeFrame: 35 minutes after carbohydrates consumption
measure: Percentage of participants requiring a second treatment with carbohydrates at 20 minutes after the first CHO consumption
timeFrame: 20 minutes after carbohydrates consumption
measure: Percentage of participants requiring a second treatment with carbohydrates at 40 minutes after the first CHO consumption
timeFrame: 40 minutes after carbohydrates consumption
measure: Percentage of participants requiring a second treatment with carbohydrates at 60 minutes after the first CHO consumption
timeFrame: 60 minutes after carbohydrates consumption
measure: Percentage of participants experiencing a rebound hyperglycemia (≥ 10.0 mmol/L) within the first hour following the first carbobydrates consumption
timeFrame: 60 minutes after carbohydrates consumption
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Montreal Clinical Research Institute
state: Quebec
Study officials:
affiliation: Institut de recherches cliniques de Montréal
name: Rémi Rabasa-Lhoret
role: PRINCIPAL_INVESTIGATOR
References: