Oral Carbohydrates for Hypoglycemia in Type 1 Diabetes

(REMODAL Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Remi Rabasa-Lhoret

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Institut de Recherches Cliniques de Montreal

Must be taking: Insulin

Disqualifiers: Gastroparesis, Cardiac abnormalities, Epilepsy, others

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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. ^{6 11 12 13 14}

Research Team

Remi Rabasa-Lhoret

Principal Investigator

IRCM

Eligibility Criteria

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

I am 18 years old or older.

HbA1c level below 9.0%

I am currently managing my diabetes with insulin injections or an insulin pump.

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.

Trial Timeline

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

Treatment Details

Interventions

• Oral Carbohydrate (Other)

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.

Participant Groups

Group I: 8g CHO at 5.0 mmol/L (Proactive Approach) Experimental Treatment 1 Intervention

Participants receive 8 grams of carbohydrate when their CGM reading reaches a proactive threshold of 5.0 mmol/L. This arm tests whether a lower amount of CHO, administered at a higher glucose level, can effectively prevent hypoglycemia with minimal caloric intake.

Group II: 16g CHO at 5.0 mmol/L (Proactive Approach) Experimental Treatment 1 Intervention

Participants receive 16 grams of carbohydrate at the proactive threshold of 5.0 mmol/L. This arm examines if a slightly higher dose of CHO at the same proactive threshold provides additional preventive benefits compared to 8 grams, while still aiming to avoid hypoglycemia and limit subsequent glucose fluctuations.

Group III: 16g CHO at < 4.0 mmol/L (Reactive Approach) Placebo Group 1 Intervention

Participants receive 16 grams of carbohydrate only when their CGM reading falls below 4.0 mmol/L, in line with the traditional "reactive" approach. This arm serves as a control, reflecting current hypoglycemia treatment guidelines, allowing comparison to proactive interventions.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Institut de recherches cliniques de Montréal Montreal, Canada

Montreal Clinical Research Institute Montreal, Canada

Who Is Running the Clinical Trial?

Institut de Recherches Cliniques de Montreal

Lead Sponsor

Trials

72

Patients Recruited

10,300+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-carbohydrate diets for type 1 diabetes mellitus: A systematic review. Turton, JL., Raab, R., Rooney, KB.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effective treatment of hypoglycemia in children with type 1 diabetes: a randomized controlled clinical trial. McTavish, L., Wiltshire, E.[2013]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of glucose, sucrose, and fructose in treating hypoglycemia in children with type 1 diabetes. Husband, AC., Crawford, S., McCoy, LA., et al.[2013]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Krebs, JD., Parry Strong, A., Cresswell, P., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mini-doses of glucagon to prevent hypoglycemia in children with type 1 diabetes refusing food: a case series. Tinti, D., Rabbone, I.[2020]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meal composition is a determinant of lispro-induced hypoglycemia in IDDM. Burge, MR., Castillo, KR., Schade, DS.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dasiglucagon-A Next-Generation Glucagon Analog for Rapid and Effective Treatment of Severe Hypoglycemia: Results of Phase 3 Randomized Double-Blind Clinical Trial. Pieber, TR., Aronson, R., Hövelmann, U., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intranasal Glucagon: A New Way to Treat Hypoglycemic Emergencies. Lowe, RN., Trujillo, JM.[2020]

Intranasal glucagon is effective in treating severe hypoglycemia in patients with diabetes, showing a rapid increase in blood glucose levels within 15-30 minutes, similar to injectable glucagon, based on a systematic review of 10 studies.

Most caregivers preferred intranasal glucagon due to its ease of use, with administration times significantly faster than injectable forms, highlighting its potential for improving emergency treatment in disoriented or unconscious patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Usability of Intranasal Glucagon for the Management of Hypoglycemia in Patients With Diabetes: A Systematic Review. Singh-Franco, D., Moreau, C., Levin, AD., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Treatment of Nonsevere Hypoglycemia in Adults With Type 1 Diabetes Using Oral Carbohydrates During Automated Insulin Delivery With and Without Glucagon. Taleb, N., Cheng, R., Wu, Z., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimal Carbohydrate Dose for Treatment of Nonsevere Hypoglycemia in Insulin-Treated Patients With Diabetes: A Narrative Review. Urbanová, J., Frier, BM., Taniwall, A., et al.[2022]

NCBI (Pubmed)

pubmed.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. Eik Filho, W., Wanczinski Ferrari, BJ., Masetto Antunes, M., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Grassi, B., Onetto, MT., Zapata, Y., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Low-carbohydrate diets for type 1 diabetes mellitus: A systematic review. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Predictive Low-Glucose Suspend Necessitates Less Carbohydrate Supplementation to Rescue Hypoglycemia: Need to Revisit Current Hypoglycemia Treatment Guidelines. [2022]

3. Denmark pubmed.ncbi.nlm.nih.gov

Effective treatment of hypoglycemia in children with type 1 diabetes: a randomized controlled clinical trial. [2013]

4. Denmark pubmed.ncbi.nlm.nih.gov

The effectiveness of glucose, sucrose, and fructose in treating hypoglycemia in children with type 1 diabetes. [2013]

5. China pubmed.ncbi.nlm.nih.gov

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]

6. Germany pubmed.ncbi.nlm.nih.gov

Mini-doses of glucagon to prevent hypoglycemia in children with type 1 diabetes refusing food: a case series. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Meal composition is a determinant of lispro-induced hypoglycemia in IDDM. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Dasiglucagon-A Next-Generation Glucagon Analog for Rapid and Effective Treatment of Severe Hypoglycemia: Results of Phase 3 Randomized Double-Blind Clinical Trial. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Intranasal Glucagon: A New Way to Treat Hypoglycemic Emergencies. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Usability of Intranasal Glucagon for the Management of Hypoglycemia in Patients With Diabetes: A Systematic Review. [2021]

11. Canada pubmed.ncbi.nlm.nih.gov

Efficacy of Treatment of Nonsevere Hypoglycemia in Adults With Type 1 Diabetes Using Oral Carbohydrates During Automated Insulin Delivery With and Without Glucagon. [2023]

12. Canada pubmed.ncbi.nlm.nih.gov

Optimal Carbohydrate Dose for Treatment of Nonsevere Hypoglycemia in Insulin-Treated Patients With Diabetes: A Narrative Review. [2022]

13. United States pubmed.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]

14. Netherlands pubmed.ncbi.nlm.nih.gov

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]