Status:
COMPLETED
Prevention of Mild-to-moderate Hypoglycemia in Type 1 Diabetes
Lead Sponsor:
Institut de Recherches Cliniques de Montreal
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
18+ years
Phase:
NA
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 r...
Eligibility Criteria
Inclusion
- 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%
Exclusion
- 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)
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04876079
Start Date
June 1 2021
End Date
June 30 2023
Last Update
August 31 2023
Active Locations (1)
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1
Montreal Clinical Research Institute
Montreal, Quebec, Canada, H2W 1R7