Clinical trial NCT03489967: Treatment of Hypoglycemia in Type 1 Diabetes
Official title: Treatment of Mild-to-moderate Hypoglycemia in Adults With Type 1 Diabetes: a Validation Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Keywords: Hypoglycemia, carbohydrates
Lead sponsor: Institut de Recherches Cliniques de Montreal
Sponsor class: OTHER
First posted: 2018-04-06
Enrollment: 29
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 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.


Eligibility criteria: Inclusion Criteria:

1. Males and females ≥ 18 years of old.
2. Clinical diagnosis of type 1 diabetes for at least one year.
3. Treatment with multiple daily insulin injections or insulin pump therapy and using insulin analogs (rapid, ultra-rapid and basal).
4. HbA1c ≤ 10%.

Exclusion Criteria:

1. Clinically significant microvascular complications: nephropathy (estimated glomerular filtration rate below 40 ml/min), neuropathy (especially diagnosed gastroparesis) or severe proliferative retinopathy as judged by the investigator.
2. Recent (\< 3 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
3. Known significant cardiac rhythm abnormality based on investigator judgment.
4. Abnormal blood panel and/or anemia (Hb \< 100g/L).
5. Ongoing pregnancy or breastfeeding.
6. Severe hypoglycemic episode within 1 month of screening.
7. Known uncorrected hypokalemia (potassium \< 3.5 mmol/L; available within the past 3 months).

Primary outcomes:
measure: Change in glucose levels 15 minutes after hypoglycemic treatment
timeFrame: 15 minutes after hypoglycemic treatment
Secondary outcomes:
measure: Change in glucose levels 20 minutes after hypoglycemic treatment
timeFrame: 20 minutes after hypoglycemic treatment
measure: Change in glucose levels 30 minutes after hypoglycemic treatment
timeFrame: 30 minutes after hypoglycemic treatment
measure: Change in glucose levels 45 minutes after hypoglycemic treatment
timeFrame: 45 minutes after hypoglycemic treatment
measure: Change in glucose levels 60 minutes after hypoglycemic treatment
timeFrame: 60 minutes after hypoglycemic treatment
measure: Number of participants with glucose levels above 8.0 mmol/L 1 hour after hypoglycemia correction
timeFrame: 60 minutes after hypoglycemia correction
measure: Number of participants with glucose levels above 10.0 mmol/L 1 hour after hypoglycemia correction
timeFrame: 60 minutes after hypoglycemia correction
measure: Glucose levels 60 minutes after meal consumption
timeFrame: 60 minutes after meal consumption
measure: Glucose levels 90 minutes after meal consumption
timeFrame: 90 minutes after meal consumption
measure: Number of patients for whom hypoglycemia was corrected 10 minutes after hypoglycemic treatment
timeFrame: 10 minutes after hypoglycemic treatment
measure: Number of patients for whom hypoglycemia was corrected 15 minutes after hypoglycemic treatment
timeFrame: 15 minutes after hypoglycemic treatment
measure: Number of patients for whom hypoglycemia was corrected 20 minutes after hypoglycemic treatment
timeFrame: 20 minutes after hypoglycemic treatment
measure: Number of patients for whom hypoglycemia was corrected 25 minutes after hypoglycemic treatment
timeFrame: 25 minutes after hypoglycemic treatment
measure: Number of patients for whom hypoglycemia was corrected 30 minutes after hypoglycemic treatment
timeFrame: 30 minutes after hypoglycemic treatment
measure: Number of patients for whom hypoglycemia was corrected 35 minutes after hypoglycemic treatment
timeFrame: 35 minutes after hypoglycemic treatment
measure: Number of hypoglycemic events corrected 10 minutes after hypoglycemic treatment
timeFrame: 10 minutes after hypoglycemic treatment
measure: Number of hypoglycemic events corrected 15 minutes after hypoglycemic treatment
timeFrame: 15 minutes after hypoglycemic treatment
measure: Number of hypoglycemic events corrected 20 minutes after hypoglycemic treatment
timeFrame: 20 minutes after hypoglycemic treatment
measure: Number of hypoglycemic events corrected 25 minutes after hypoglycemic treatment
timeFrame: 25 minutes after hypoglycemic treatment
measure: Number of hypoglycemic events corrected 30 minutes after hypoglycemic treatment
timeFrame: 30 minutes after hypoglycemic treatment
measure: Number of hypoglycemic events corrected 35 minutes after hypoglycemic treatment
timeFrame: 35 minutes after hypoglycemic treatment
measure: Number of patients for whom hypoglycemia symptoms disappeared 10 minutes after hypoglycemic treatment
timeFrame: 10 minutes after hypoglycemic treatment
measure: Number of patients for whom hypoglycemia symptoms disappeared 15 minutes after hypoglycemic treatment
timeFrame: 15 minutes after hypoglycemic treatment
measure: Number of patients for whom hypoglycemia symptoms disappeared 20 minutes after hypoglycemic treatment
timeFrame: 20 minutes after hypoglycemic treatment
measure: Number of patients for whom hypoglycemia symptoms disappeared 25 minutes after hypoglycemic treatment
timeFrame: 25 minutes after hypoglycemic treatment
measure: Number of patients for whom hypoglycemia symptoms disappeared 30 minutes after hypoglycemic treatment
timeFrame: 30 minutes after hypoglycemic treatment
measure: Number of patients for whom hypoglycemia symptoms disappeared 35 minutes after hypoglycemic treatment
timeFrame: 35 minutes after hypoglycemic treatment
measure: Number of patients requiring a second treatment 40 minutes after the first hypoglycemic treatment
timeFrame: 40 minutes after the first hypoglycemic treatment
measure: Number of patients requiring a second treatment 15 minutes after the first hypoglycemic treatment
timeFrame: 15 minutes after the first hypoglycemic treatment
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Institut de recherches cliniques de Montréal
Study officials:
affiliation: Institut de recherches cliniques de Montréal
name: Remi Rabasa-Lhoret
role: PRINCIPAL_INVESTIGATOR
References: