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Completed

NCT Number: NCT03489967

Treatment of Hypoglycemia in Type 1 Diabetes

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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Hypoglycemia Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut de recherches cliniques de Montréal

Montreal, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.
  • Recent (< 3 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
  • Known significant cardiac rhythm abnormality based on investigator judgment.
  • Abnormal blood panel and/or anemia (Hb < 100g/L).
  • Ongoing pregnancy or breastfeeding.
  • Severe hypoglycemic episode within 1 month of screening.
  • Known uncorrected hypokalemia (potassium < 3.5 mmol/L; available within the past 3 months).

Treatment and study plan

Induced-hypoglycemia test

Other

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 induce hypoglycemia. Oral treatment (16g of carbohydrates or 32g of carbohydrates) will be given when plasma glucose levels are at the target threshold of < 3.0 mmol/L or 3.0-3.5 mmol/L. Hypoglycemia symptoms will be assessed every 10 minutes by the participant using a validated scale starting from the time of insulin bolus until hypoglycemia recovery. One hour after hypoglycemia recovery, a standardized meal will be given.

Primary outcomes

  1. Change in glucose levels 15 minutes after hypoglycemic treatment

    Time frame: 15 minutes after hypoglycemic treatment

    Change in glucose levels 15 minutes after hypoglycemic treatment (16g vs. 32g of carbohydrates) when glucose levels at the time of treatment are below 3.0 mmol/L or between 3.0 and 3.5 mmol/L.

Secondary outcomes

  1. Change in glucose levels 20 minutes after hypoglycemic treatment

    Time frame: 20 minutes after hypoglycemic treatment

    Change in glucose levels 20 minutes after hypoglycemic treatment (16g vs. 32g of carbohydrates) when glucose levels at the time of treatment are below 3.0 mmol/L or between 3.0 and 3.5 mmol/L.

  2. Change in glucose levels 30 minutes after hypoglycemic treatment

    Time frame: 30 minutes after hypoglycemic treatment

    Change in glucose levels 30 minutes after hypoglycemic treatment (16g vs. 32g of carbohydrates) when glucose levels at the time of treatment are below 3.0 mmol/L or between 3.0 and 3.5 mmol/L.

  3. Change in glucose levels 45 minutes after hypoglycemic treatment

    Time frame: 45 minutes after hypoglycemic treatment

    Change in glucose levels 45 minutes after hypoglycemic treatment (16g vs. 32g of carbohydrates) when glucose levels at the time of treatment are below 3.0 mmol/L or between 3.0 and 3.5 mmol/L.

  4. Change in glucose levels 60 minutes after hypoglycemic treatment

    Time frame: 60 minutes after hypoglycemic treatment

    Change in glucose levels 60 minutes after hypoglycemic treatment (16g vs. 32g of carbohydrates) when glucose levels at the time of treatment are below 3.0 mmol/L or between 3.0 and 3.5 mmol/L.

  5. Number of participants with glucose levels above 8.0 mmol/L 1 hour after hypoglycemia correction

    Time frame: 60 minutes after hypoglycemia correction

  6. Number of participants with glucose levels above 10.0 mmol/L 1 hour after hypoglycemia correction

    Time frame: 60 minutes after hypoglycemia correction

  7. Glucose levels 60 minutes after meal consumption

    Time frame: 60 minutes after meal consumption

  8. Glucose levels 90 minutes after meal consumption

    Time frame: 90 minutes after meal consumption

  9. Number of patients for whom hypoglycemia was corrected 10 minutes after hypoglycemic treatment

    Time frame: 10 minutes after hypoglycemic treatment

  10. Number of patients for whom hypoglycemia was corrected 15 minutes after hypoglycemic treatment

    Time frame: 15 minutes after hypoglycemic treatment

  11. Number of patients for whom hypoglycemia was corrected 20 minutes after hypoglycemic treatment

    Time frame: 20 minutes after hypoglycemic treatment

  12. Number of patients for whom hypoglycemia was corrected 25 minutes after hypoglycemic treatment

    Time frame: 25 minutes after hypoglycemic treatment

  13. Number of patients for whom hypoglycemia was corrected 30 minutes after hypoglycemic treatment

    Time frame: 30 minutes after hypoglycemic treatment

  14. Number of patients for whom hypoglycemia was corrected 35 minutes after hypoglycemic treatment

    Time frame: 35 minutes after hypoglycemic treatment

  15. Number of hypoglycemic events corrected 10 minutes after hypoglycemic treatment

    Time frame: 10 minutes after hypoglycemic treatment

  16. Number of hypoglycemic events corrected 15 minutes after hypoglycemic treatment

    Time frame: 15 minutes after hypoglycemic treatment

  17. Number of hypoglycemic events corrected 20 minutes after hypoglycemic treatment

    Time frame: 20 minutes after hypoglycemic treatment

  18. Number of hypoglycemic events corrected 25 minutes after hypoglycemic treatment

    Time frame: 25 minutes after hypoglycemic treatment

  19. Number of hypoglycemic events corrected 30 minutes after hypoglycemic treatment

    Time frame: 30 minutes after hypoglycemic treatment

  20. Number of hypoglycemic events corrected 35 minutes after hypoglycemic treatment

    Time frame: 35 minutes after hypoglycemic treatment

  21. Number of patients for whom hypoglycemia symptoms disappeared 10 minutes after hypoglycemic treatment

    Time frame: 10 minutes after hypoglycemic treatment

  22. Number of patients for whom hypoglycemia symptoms disappeared 15 minutes after hypoglycemic treatment

    Time frame: 15 minutes after hypoglycemic treatment

  23. Number of patients for whom hypoglycemia symptoms disappeared 20 minutes after hypoglycemic treatment

    Time frame: 20 minutes after hypoglycemic treatment

  24. Number of patients for whom hypoglycemia symptoms disappeared 25 minutes after hypoglycemic treatment

    Time frame: 25 minutes after hypoglycemic treatment

  25. Number of patients for whom hypoglycemia symptoms disappeared 30 minutes after hypoglycemic treatment

    Time frame: 30 minutes after hypoglycemic treatment

  26. Number of patients for whom hypoglycemia symptoms disappeared 35 minutes after hypoglycemic treatment

    Time frame: 35 minutes after hypoglycemic treatment

  27. Number of patients requiring a second treatment 40 minutes after the first hypoglycemic treatment

    Time frame: 40 minutes after the first hypoglycemic treatment

  28. Number of patients requiring a second treatment 15 minutes after the first hypoglycemic treatment

    Time frame: 15 minutes after the first hypoglycemic treatment

Sponsors and collaborators

Lead sponsor

Institut de Recherches Cliniques de Montreal

Other

Registry information

Official study title

Treatment of Mild-to-moderate Hypoglycemia in Adults With Type 1 Diabetes: a Validation Study

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Apr 6, 2018
Registry last updated
Sep 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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