32 Participants Needed

Oral Carbohydrates for Hypoglycemia in Type 1 Diabetes

(REMODAL Trial)

Recruiting at 1 trial location
VB
CS
VB
Overseen ByValérie Boudreau, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Institut de Recherches Cliniques de Montreal
Must be taking: Insulin

What You Need to Know Before You Apply

What is the purpose of this trial?

The REMODAL trial is a randomized crossover study aiming to update treatment guidelines for mild hypoglycemia in people with Type 1 diabetes using continuous glucose monitoring (CGM) technology. The study will assess whether treating mild hypoglycemia proactively (at a glucose threshold of 5.0 mmol/L) with lower doses of carbohydrate (CHO) is more effective than the traditional reactive approach (treatment at \< 4.0 mmol/L). The goal is to reduce hypoglycemia frequency and improve quality of life, while minimizing caloric intake and rebound hyperglycemia.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does mention that participants should not have anticipated treatment changes during the trial period. This might mean you should continue your current treatment without changes.

Is oral carbohydrate safe for treating hypoglycemia in type 1 diabetes?

The research articles provided do not contain specific safety data on oral carbohydrates for treating hypoglycemia in type 1 diabetes.12345

How does the oral carbohydrate treatment for hypoglycemia in type 1 diabetes differ from other treatments?

The oral carbohydrate treatment for hypoglycemia in type 1 diabetes is unique because it involves the use of simple carbohydrates, like glucose, which are rapidly absorbed to quickly raise blood sugar levels. This approach is different from other treatments like glucagon injections, which are used when oral carbohydrates cannot be administered, such as in cases of nausea or food refusal.16789

What data supports the effectiveness of the treatment Oral Carbohydrate for hypoglycemia in Type 1 Diabetes?

Research shows that oral carbohydrates like glucose, sucrose, and fructose are effective in treating hypoglycemia (low blood sugar) in children with type 1 diabetes. Additionally, current guidelines recommend using 15-20 grams of carbohydrates to manage mild to moderate hypoglycemia, although some studies suggest that less may be needed in certain situations.1011121314

Who Is on the Research Team?

RR

Remi Rabasa-Lhoret

Principal Investigator

IRCM

Are You a Good Fit for This Trial?

This trial is for individuals with Type 1 Diabetes who regularly monitor their blood sugar using CGM. It's designed to find better ways to prevent and treat low blood sugar episodes. Participants should be willing to try different carbohydrate amounts when their sugar levels drop.

Inclusion Criteria

HbA1c level below 9.0%
I am currently managing my diabetes with insulin injections or an insulin pump.
I am either male or female and use an insulin pump or injections for diabetes management.
See 1 more

Exclusion Criteria

I have serious heart rhythm problems.
I have gastroparesis.
I haven't had major blood vessel problems or low potassium levels in the last 3 months.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive different carbohydrate interventions to manage hypoglycemia using CGM technology

6 weeks
Multiple visits for each intervention

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Oral Carbohydrate
Trial Overview The REMODAL trial is testing if taking a smaller amount of carbohydrates at an earlier sign of dropping blood sugar (5.0 mmol/L) can help avoid hypoglycemia more effectively than the usual method of waiting until it falls below 4.0 mmol/L.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Placebo Group
Group I: 8g CHO at 5.0 mmol/L (Proactive Approach)Experimental Treatment1 Intervention
Group II: 16g CHO at 5.0 mmol/L (Proactive Approach)Experimental Treatment1 Intervention
Group III: 16g CHO at < 4.0 mmol/L (Reactive Approach)Placebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Institut de Recherches Cliniques de Montreal

Lead Sponsor

Trials
72
Recruited
10,300+

Published Research Related to This Trial

A systematic review of nine studies on low-carbohydrate diets for managing type 1 diabetes found that while some studies reported significant reductions in HbA1c, the overall effect was inconclusive due to significant variability among the studies.
The review highlights the need for more rigorous primary studies to better understand the impact of low-carbohydrate diets on diabetes management, as current evidence is limited and mixed.
Low-carbohydrate diets for type 1 diabetes mellitus: A systematic review.Turton, JL., Raab, R., Rooney, KB.[2022]
In a study involving 10 adults with type 1 diabetes, the use of a predictive low-glucose suspend (PLGS) system resulted in fewer carbohydrate (CHO) treatments for hypoglycemia, with a median of only 9g CHO needed during hypoglycemic events.
The findings suggest that current guidelines recommending 15-20g of CHO for treating mild to moderate hypoglycemia may need to be updated, as lower amounts may be sufficient during insulin suspensions to prevent rebound hyperglycemia.
Predictive Low-Glucose Suspend Necessitates Less Carbohydrate Supplementation to Rescue Hypoglycemia: Need to Revisit Current Hypoglycemia Treatment Guidelines.Pinsker, JE., Bartee, A., Katz, M., et al.[2022]
In a study involving 39 children with type 1 diabetes, jellybeans were found to be the least effective treatment for hypoglycemia, requiring more repeat doses compared to glucose tablets, orange juice, and sugar mints.
Glucose tablets, Mentos dragees®, and orange juice showed similar efficacy in resolving hypoglycemia, with most children needing about 15 minutes for their blood glucose levels to normalize after treatment.
Effective treatment of hypoglycemia in children with type 1 diabetes: a randomized controlled clinical trial.McTavish, L., Wiltshire, E.[2013]

Citations

Low-carbohydrate diets for type 1 diabetes mellitus: A systematic review. [2022]
Predictive Low-Glucose Suspend Necessitates Less Carbohydrate Supplementation to Rescue Hypoglycemia: Need to Revisit Current Hypoglycemia Treatment Guidelines. [2022]
Effective treatment of hypoglycemia in children with type 1 diabetes: a randomized controlled clinical trial. [2013]
The effectiveness of glucose, sucrose, and fructose in treating hypoglycemia in children with type 1 diabetes. [2013]
A randomised trial of the feasibility of a low carbohydrate diet vs standard carbohydrate counting in adults with type 1 diabetes taking body weight into account. [2022]
Mini-doses of glucagon to prevent hypoglycemia in children with type 1 diabetes refusing food: a case series. [2020]
Meal composition is a determinant of lispro-induced hypoglycemia in IDDM. [2019]
Dasiglucagon-A Next-Generation Glucagon Analog for Rapid and Effective Treatment of Severe Hypoglycemia: Results of Phase 3 Randomized Double-Blind Clinical Trial. [2022]
Intranasal Glucagon: A New Way to Treat Hypoglycemic Emergencies. [2020]
10.United Statespubmed.ncbi.nlm.nih.gov
Efficacy and Usability of Intranasal Glucagon for the Management of Hypoglycemia in Patients With Diabetes: A Systematic Review. [2021]
Efficacy of Treatment of Nonsevere Hypoglycemia in Adults With Type 1 Diabetes Using Oral Carbohydrates During Automated Insulin Delivery With and Without Glucagon. [2023]
Optimal Carbohydrate Dose for Treatment of Nonsevere Hypoglycemia in Insulin-Treated Patients With Diabetes: A Narrative Review. [2022]
13.United Statespubmed.ncbi.nlm.nih.gov
Glycerol Potentiates the Effects of Glucose in Promoting Glucose Recovery During Hypoglycemia: From Basic to Clinical Investigations and Their Therapeutic Application. [2021]
Lower versus standard sucrose dose for treating hypoglycemia in patients with type 1 diabetes mellitus in therapy with predictive low glucose suspend (PLGS) augmented insulin pumps: A randomized crossover trial in Santiago, Chile. [2021]
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