Prevention of Mild-to-moderate Hypoglycemia in Type 1 Diabetes (REVERSIBLE)

March 3, 2026 updated by: Rémi Rabasa-Lhoret, Institut de Recherches Cliniques de Montreal

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H2W 1R7
        • Montreal Clinical Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Males and females ≥ 18 years old
  2. Clinical diagnosis of type 1 diabetes for at least one year
  3. Treatment with multiple daily insulin injections or insulin pump therapy with insulin analogs (rapid, ultra-rapid and basal insulin)
  4. A glycated hemoglobin A1c ≤ 10%

Exclusion Criteria:

  1. Clinically significant microvascular complications: nephropathy (eGFR < 40 ml/min), severe proliferative retinopathy as judged by the investigator, neuropathy (particularly diagnosed gastroparesis)
  2. Recent (< 3 months) acute macrovascular event (e.g., acute coronary syndrome or cardiac surgery)
  3. Known significant cardiac rhythm abnormality based on investigator's judgement
  4. Known significant neurological abnormality (e.g., seizure disorder) based on investigator's judgement
  5. Ongoing pregnancy or breastfeeding
  6. Severe hypoglycemia episode within 1 month of screening
  7. Known uncorrected hypokalemia within the past 3 months (potassium < 3.5 mmol/L)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 16g of carbohydrates - Plasma glucose < 4.0 mmol/L
16g of carbohydrates will be given when glucose levels are below 4.0 mmol/L (management per guidelines)
Other: Test to induce a decline in plasma glucose
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.
Device: Dexcom G6
Participants will have to wear a Dexcom G6 during study interventions
Other: Dex4
When the glycemic threshold is reach, participants will be given 16g of Dex4
Drug: Insulin
A subcutaneous insulin bolus will be given to induce a decline in plasma glucose and reach the glycemic threshold.
Active Comparator: 16g of carbohydrates - Plasma glucose ≤ 4.5 mmol/L
16g of carbohydrates will be given when glucose levels are equal or below 4.5 mmol/L.
Other: Test to induce a decline in plasma glucose
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.
Device: Dexcom G6
Participants will have to wear a Dexcom G6 during study interventions
Other: Dex4
When the glycemic threshold is reach, participants will be given 16g of Dex4
Drug: Insulin
A subcutaneous insulin bolus will be given to induce a decline in plasma glucose and reach the glycemic threshold.
Active Comparator: 16g of carbohydrates - Plasma glucose ≤ 5.0 mmol/L
16g of carbohydrates will be given when glucose levels are equal or below 5.0 mmol/L.
Other: Test to induce a decline in plasma glucose
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.
Device: Dexcom G6
Participants will have to wear a Dexcom G6 during study interventions
Other: Dex4
When the glycemic threshold is reach, participants will be given 16g of Dex4
Drug: Insulin
A subcutaneous insulin bolus will be given to induce a decline in plasma glucose and reach the glycemic threshold.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Time spent of glucose levels < 4.0 mmol/L
Time Frame: 60 minutes after carbohydrates consumption
60 minutes after carbohydrates consumption

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Plasma glucose levels at 5 minutes after carbohydrates consumption
Time Frame: 5 minutes after carbohydrates consumption
5 minutes after carbohydrates consumption
Plasma glucose levels at 10 minutes after carbohydrates consumption
Time Frame: 10 minutes after carbohydrates consumption
10 minutes after carbohydrates consumption
Plasma glucose levels at 15 minutes after carbohydrates consumption
Time Frame: 15 minutes after carbohydrates consumption
15 minutes after carbohydrates consumption
Plasma glucose levels at 20 minutes after carbohydrates consumption
Time Frame: 20 minutes after carbohydrates consumption
20 minutes after carbohydrates consumption
Plasma glucose levels at 30 minutes after carbohydrates consumption
Time Frame: 30 minutes after carbohydrates consumption
30 minutes after carbohydrates consumption
Plasma glucose levels at 45 minutes after carbohydrates consumption
Time Frame: 45 minutes after carbohydrates consumption
45 minutes after carbohydrates consumption
Plasma glucose levels at 60 minutes after carbohydrates consumption
Time Frame: 60 minutes after carbohydrates consumption
60 minutes after carbohydrates consumption
Lowest plasma glucose level eached after CHO consumption
Time Frame: 60 minutes after carbohydrates consumption
60 minutes after carbohydrates consumption
Time from CHO consumption to the lowest plasma glucose level reached
Time Frame: 60 minutes after carbohydrates consumption
60 minutes after carbohydrates consumption
Time from CHO consumption to plasma glucose < 3.5 mmol/L
Time Frame: 60 minutes after carbohydrates consumption
60 minutes after carbohydrates consumption
Percentage of participants reaching hypoglycemia (< 4.0 mmol/L) after CHO consumption
Time Frame: 60 minutes after carbohydrates consumption
60 minutes after carbohydrates consumption
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
10 minutes after carbohydrates consumption
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
15 minutes after carbohydrates consumption
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
20 minutes after carbohydrates consumption
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
25 minutes after carbohydrates consumption
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
30 minutes after carbohydrates consumption
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
35 minutes after carbohydrates consumption
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
10 minutes after carbohydrates consumption
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
15 minutes after carbohydrates consumption
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
20 minutes after carbohydrates consumption
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
25 minutes after carbohydrates consumption
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
30 minutes after carbohydrates consumption
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
35 minutes after carbohydrates consumption
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
20 minutes after carbohydrates consumption
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
40 minutes after carbohydrates consumption
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
60 minutes after carbohydrates consumption
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
60 minutes after carbohydrates consumption

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Institut de Recherches Cliniques de Montreal

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Rémi Rabasa-Lhoret, Institut de recherches cliniques de Montréal

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 3, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 3, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 6, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2022-1119

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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