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Completed

NCT Number: NCT04876079

Prevention of Mild-to-moderate 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. 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).

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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

Montreal Clinical Research Institute

Montreal, Quebec, H2W 1R7, 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 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)

Treatment and study plan

Test to induce a decline in plasma glucose

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 bring plasma glucose to the glycemic threshold. Oral carbohydrates (16g) will be given when plasma glucose levels are at the target threshold. Sixty minutes after carbohydrates consumption, a standardized meal will be provided and participants will be discharged 90 minutes after the meal.

Dexcom G6

Device

Participants will have to wear a Dexcom G6 during study interventions

Dex4

Other

When the glycemic threshold is reach, participants will be given 16g of Dex4

Insulin

Drug

A subcutaneous insulin bolus will be given to induce a decline in plasma glucose and reach the glycemic threshold.

Primary outcomes

  1. Time spent of glucose levels < 4.0 mmol/L

    Time frame: 60 minutes after carbohydrates consumption

Secondary outcomes

  1. Plasma glucose levels at 5 minutes after carbohydrates consumption

    Time frame: 5 minutes after carbohydrates consumption

  2. Plasma glucose levels at 10 minutes after carbohydrates consumption

    Time frame: 10 minutes after carbohydrates consumption

  3. Plasma glucose levels at 15 minutes after carbohydrates consumption

    Time frame: 15 minutes after carbohydrates consumption

  4. Plasma glucose levels at 20 minutes after carbohydrates consumption

    Time frame: 20 minutes after carbohydrates consumption

  5. Plasma glucose levels at 30 minutes after carbohydrates consumption

    Time frame: 30 minutes after carbohydrates consumption

  6. Plasma glucose levels at 45 minutes after carbohydrates consumption

    Time frame: 45 minutes after carbohydrates consumption

  7. Plasma glucose levels at 60 minutes after carbohydrates consumption

    Time frame: 60 minutes after carbohydrates consumption

  8. Lowest plasma glucose level eached after CHO consumption

    Time frame: 60 minutes after carbohydrates consumption

  9. Time from CHO consumption to the lowest plasma glucose level reached

    Time frame: 60 minutes after carbohydrates consumption

  10. Time from CHO consumption to plasma glucose < 3.5 mmol/L

    Time frame: 60 minutes after carbohydrates consumption

  11. Percentage of participants reaching hypoglycemia (< 4.0 mmol/L) after CHO consumption

    Time frame: 60 minutes after carbohydrates consumption

  12. Percentage of participants for whom hypoglycemia was corrected at 10 minutes after CHO consumption

    Time frame: 10 minutes after carbohydrates consumption

    Only calculated for participants who will have glucose levels < 4.0 mmol/L

  13. Percentage of participants for whom hypoglycemia was corrected at 15 minutes after CHO consumption

    Time frame: 15 minutes after carbohydrates consumption

    Only calculated for participants who will have glucose levels < 4.0 mmol/L

  14. Percentage of participants for whom hypoglycemia was corrected at 20 minutes after CHO consumption

    Time frame: 20 minutes after carbohydrates consumption

    Only calculated for participants who will have glucose levels < 4.0 mmol/L

  15. Percentage of participants for whom hypoglycemia was corrected at 25 minutes after CHO consumption

    Time frame: 25 minutes after carbohydrates consumption

    Only calculated for participants who will have glucose levels < 4.0 mmol/L

  16. Percentage of participants for whom hypoglycemia was corrected at 30 minutes after CHO consumption

    Time frame: 30 minutes after carbohydrates consumption

    Only calculated for participants who will have glucose levels < 4.0 mmol/L

  17. Percentage of participants for whom hypoglycemia was corrected at 35 minutes after CHO consumption

    Time frame: 35 minutes after carbohydrates consumption

    Only calculated for participants who will have glucose levels < 4.0 mmol/L

  18. Percentage of hypoglycemic events that were corrected at 10 minutes after CHO consumption

    Time frame: 10 minutes after carbohydrates consumption

    Only calculated for events with glucose level < 4.0 mmol/L

  19. Percentage of hypoglycemic events that were corrected at 15 minutes after CHO consumption

    Time frame: 15 minutes after carbohydrates consumption

    Only calculated for events with glucose level < 4.0 mmol/L

  20. Percentage of hypoglycemic events that were corrected at 20 minutes after CHO consumption

    Time frame: 20 minutes after carbohydrates consumption

    Only calculated for events with glucose level < 4.0 mmol/L

  21. Percentage of hypoglycemic events that were corrected at 25 minutes after CHO consumption

    Time frame: 25 minutes after carbohydrates consumption

    Only calculated for events with glucose level < 4.0 mmol/L

  22. Percentage of hypoglycemic events that were corrected at 30 minutes after CHO consumption

    Time frame: 30 minutes after carbohydrates consumption

    Only calculated for events with glucose level < 4.0 mmol/L

  23. Percentage of hypoglycemic events that were corrected at 35 minutes after CHO consumption

    Time frame: 35 minutes after carbohydrates consumption

    Only calculated for events with glucose level < 4.0 mmol/L

  24. Percentage of participants requiring a second treatment with carbohydrates at 20 minutes after the first CHO consumption

    Time frame: 20 minutes after carbohydrates consumption

    Only calculated for participants who will have glucose levels < 4.0 mmol/L

  25. Percentage of participants requiring a second treatment with carbohydrates at 40 minutes after the first CHO consumption

    Time frame: 40 minutes after carbohydrates consumption

    Only calculated for participants who will have glucose levels < 4.0 mmol/L

  26. Percentage of participants requiring a second treatment with carbohydrates at 60 minutes after the first CHO consumption

    Time frame: 60 minutes after carbohydrates consumption

    Only calculated for participants who will have glucose levels < 4.0 mmol/L

  27. Percentage of participants experiencing a rebound hyperglycemia (≥ 10.0 mmol/L) within the first hour following the first carbobydrates consumption

    Time frame: 60 minutes after carbohydrates consumption

Sponsors and collaborators

Lead sponsor

Institut de Recherches Cliniques de Montreal

Other

Registry information

Official study title

Towards Prevention of Mild-to-moderate Hypoglycemia in Type 1 Diabetes With Oral Glucose at a Higher Blood Glucose Threshold

Acronym: REVERSIBLE

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
May 6, 2021
Registry last updated
Mar 5, 2026

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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