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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    29
  • sponsor
    Institut de Recherches Cliniques de Montreal
Updated on 19 July 2021
Investigator
Virginie Messier
Primary Contact
Montreal Clinical Research Institute (0.7 mi away) Contact
diabetes
insulin
capillary blood
hemoglobin a1c
hypoglycemia
plasma glucose

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).

Details
Condition Diabetes Mellitus, Insulin dependent diabetes mellitus, Autoimmune disease, type 1 diabetes mellitus, type 1 diabetes, diabetes type 1, diabetes mellitus type 1, insulin-dependent diabetes, iddm, type i diabetes mellitus
Treatment insulin, Dexcom G6, Test to induce a decline in plasma glucose, Dex4
Clinical Study IdentifierNCT04876079
SponsorInstitut de Recherches Cliniques de Montreal
Last Modified on19 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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 Criteria

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)
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