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Insulin

16g of carbohydrates - Plasma glucose < 4.0 mmol/L for Type 1 Diabetes (REVERSIBLE Trial)

N/A
Waitlist Available
Led By Rémi Rabasa-Lhoret
Research Sponsored by Institut de Recherches Cliniques de Montreal
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 minutes after carbohydrates consumption
Awards & highlights

REVERSIBLE Trial Summary

This trial tests if a new approach to treating hypoglycemia, where patients proactively treat hypoglycemia before it happens, is more effective than the current standard of care.

Eligible Conditions
  • Type 1 Diabetes

REVERSIBLE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 minutes after carbohydrates consumption
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 minutes after carbohydrates consumption for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time spent of glucose levels < 4.0 mmol/L
Secondary outcome measures
Lowest plasma glucose level eached after CHO consumption
Percentage of hypoglycemic events that were corrected at 10 minutes after CHO consumption
Percentage of hypoglycemic events that were corrected at 15 minutes after CHO consumption
+24 more

REVERSIBLE Trial Design

3Treatment groups
Active Control
Group I: 16g of carbohydrates - Plasma glucose < 4.0 mmol/LActive Control4 Interventions
16g of carbohydrates will be given when glucose levels are below 4.0 mmol/L (management per guidelines)
Group II: 16g of carbohydrates - Plasma glucose ≤ 4.5 mmol/LActive Control4 Interventions
16g of carbohydrates will be given when glucose levels are equal or below 4.5 mmol/L.
Group III: 16g of carbohydrates - Plasma glucose ≤ 5.0 mmol/LActive Control4 Interventions
16g of carbohydrates will be given when glucose levels are equal or below 5.0 mmol/L.

Find a Location

Who is running the clinical trial?

Institut de Recherches Cliniques de MontrealLead Sponsor
70 Previous Clinical Trials
10,338 Total Patients Enrolled
Rémi Rabasa-LhoretPrincipal InvestigatorInstitut de recherches cliniques de Montréal
17 Previous Clinical Trials
610 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there still an opportunity for individuals to join this medical experiment?

"Affirmative. According to information accessible on clinicaltrials.gov, this medical research project is actively seeking participants; the trial was first posted on June 1st 2021 and last updated October 7th 2022--and they are recruiting a total of 29 patients from one location."

Answered by AI

What other explorations have been conducted with a 16g carbohydrate dose and Plasma glucose ≤ 4.5 mmol/L?

"Presently, there are 72 medical trials being conducted for 16g of carbohydrates - Plasma glucose ≤ 4.5 mmol/L with 13 in the final stage (Phase 3). While most studies are happening in Cincinnati, Ohio, 248 other sites around the world have been operating investigations into this treatment."

Answered by AI

How many participants are currently entering this investigation?

"Affirmative. According to clinicaltrials.gov, recruitment is still ongoing for this medical trial which was originally published on June 1st 2021 and last updated on October 7th 2022. A total of 29 participants are needed from a single research facility."

Answered by AI

Who else is applying?

What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

curious to help to find effective treatment.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Prevention of Mild-to-moderate Hypoglycemia in Type 1 Diabetes
Rémi Rabasa-Lhoret 2021. "Prevention of Mild-to-moderate Hypoglycemia in Type 1 Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04876079.
~8 spots leftby Apr 2025
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