Very Low Carbohydrate Diet for Type 1 Diabetes

Overseen By Azova

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Boston Children's Hospital

Must be taking: Insulin, Metformin

Must not be taking: Psychotropic drugs

Disqualifiers: Ketoacidosis, Celiac, Eating disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 12 weeks

32 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a very low carbohydrate diet can help people with type 1 diabetes manage their blood sugar levels more effectively than a standard carbohydrate diet. Researchers will compare the effects of both diets on blood sugar control over 12 weeks. Participants must have had type 1 diabetes for at least a year, use a continuous glucose monitor and insulin pump, and maintain stable blood sugar control. The study seeks to determine if reducing carbohydrate intake can minimize blood sugar spikes and dips, potentially improving quality of life and health outcomes. As an unphased trial, this study offers participants the chance to contribute to valuable research that could enhance diabetes management strategies.

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 mentions that you cannot use medications other than insulin and metformin that could affect metabolic or glycemic variables. If you are on other medications, you might need to discuss this with the study team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that a very low carbohydrate diet might be safe for people with type 1 diabetes. Some studies suggest that this diet could help reduce episodes of low blood sugar, known as hypoglycemia, and improve overall quality of life. However, experts continue to discuss its long-term safety and effectiveness.

In one study, participants on this diet reported better blood sugar control. Their average HbA1c level, which indicates long-term blood sugar management, was 5.67%, a favorable result. This suggests the diet might help maintain stable blood sugar levels.

While these results are promising, more research is needed to fully understand any potential risks. For now, the available evidence suggests that people with type 1 diabetes generally tolerate a very low carbohydrate diet well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the very low carbohydrate diet for managing Type 1 diabetes because it represents a significant shift from the traditional dietary approach. Unlike standard carbohydrate diets, which can lead to fluctuations in blood sugar levels, this new diet focuses on minimizing carbohydrate intake to potentially stabilize glucose levels more effectively. By reducing carbs drastically, the body may rely more on fats for energy, possibly making blood sugar management less complex and reducing the need for insulin. This approach could offer a new way for individuals with Type 1 diabetes to maintain better overall control of their condition with fewer blood sugar swings.

What evidence suggests that this trial's diets could be effective for type 1 diabetes?

Research has shown that a very low carbohydrate diet, which participants in this trial may follow, can help people with type 1 diabetes manage their blood sugar levels more effectively. Studies have found that this diet reduces significant blood sugar spikes after meals and lowers HbA1c levels, an important measure of long-term blood sugar control. In a previous survey, individuals with type 1 diabetes who followed this diet had an average HbA1c of 5.67%, considered excellent. This diet may also reduce the risk of both high and low blood sugar episodes, leading to a better quality of life. These promising results suggest that a very low carbohydrate diet could effectively manage type 1 diabetes. The trial will also include a standard carbohydrate diet arm for comparison. ^{2 4 6 7 8}

Are You a Good Fit for This Trial?

Adults and adolescents aged 18-40 with Type 1 Diabetes, using an insulin pump and CGM, who have attended a diabetes care visit in the past year. They should not be on any restrictive diets or have conditions like celiac disease that affect diet.

Inclusion Criteria

Your blood sugar levels are under control and within a certain range.

You are currently using an insulin pump.

I have attended a diabetes care appointment in the last year.

Exclusion Criteria

You have a serious mental health condition.

I haven't had severe low blood sugar or ketoacidosis in the last 6 months.

You smoke, use drugs for fun, or drink too much alcohol.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Education

Participants attend an individual or group education session

1 week

1 visit (in-person)

Treatment

Participants receive a very low carbohydrate or standard carbohydrate diet for 12 weeks with continuous glucose monitoring and insulin dose adjustments

12 weeks

3 visits (in-person)

Metabolic Studies

Participants undergo metabolic studies including glucagon response and brain function assessment during hypoglycemia

During treatment phase

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Standard Carbohydrate Diet
• Very Low Carbohydrate Diet

Trial Overview The trial is comparing the effects of a very low carbohydrate diet versus a standard one on blood sugar control in people with Type 1 Diabetes over 12 weeks. Participants will receive meal deliveries and undergo regular health checks including MRI scans.

How Is the Trial Designed?

Group I: very low carbohydrate diet Experimental Treatment 1 Intervention

Dietary Intervention, food delivery

Group II: standard diet Active Control 1 Intervention

Dietary Intervention, food delivery

Who Is Running the Clinical Trial?

Boston Children's Hospital

Lead Sponsor

Trials

801

Recruited

5,584,000+

Published Research Related to This Trial

Restricting carbohydrate intake in individuals with diabetes is supported by randomized clinical trials, showing it can effectively help maintain euglycaemia and reduce the risk of hypoglycaemic episodes.

Very low-carbohydrate diets provide better glycaemic control compared to higher-carbohydrate diets, which have been criticized for contributing to the progressive nature of type 2 diabetes and the need for multiple medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Very low-carbohydrate diets in the management of diabetes revisited. Schofield, GM., Henderson, G., Thornley, S.[2017]

In a study involving 89 participants with type 2 diabetes, a very low-calorie ketogenic (VLCK) diet led to significantly greater weight loss and improved glycemic control compared to a standard low-calorie diet over 4 months.

The VLCK diet was found to be safe and well-tolerated, with no serious adverse events reported and no significant changes in laboratory safety parameters, indicating it can be a viable option for managing obesity in T2DM patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-term safety, tolerability and efficacy of a very low-calorie-ketogenic diet interventional weight loss program versus hypocaloric diet in patients with type 2 diabetes mellitus. Goday, A., Bellido, D., Sajoux, I., et al.[2022]

The very low-carbohydrate ketogenic (VLCK) diet significantly improved glycemic control and resulted in greater weight loss compared to recommended diets for up to 6 months in people with type 2 diabetes, based on a meta-analysis of 8 randomized controlled trials involving 648 participants.

While the VLCK diet showed benefits in lowering triglycerides and increasing HDL cholesterol, its effectiveness in controlling diabetes and weight did not persist beyond 6 months, and adherence to the diet was a major challenge for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a very low-carbohydrate ketogenic diet vs recommended diets in patients with type 2 diabetes: a meta-analysis. Rafiullah, M., Musambil, M., David, SK.[2022]

Participants with Type 1 diabetes who followed a restricted carbohydrate diet (75 g/day) experienced challenges with insulin management, particularly mealtime insulin resistance, indicating that careful monitoring is needed during dietary transitions.

Both groups in the study felt more empowered in managing their diabetes after a carbohydrate counting course, but those on the restricted diet reported a significant impact on their mood and perception of food, suggesting the need for additional support from healthcare professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

From 'pleasure to chemistry': the experience of carbohydrate counting with and without carbohydrate restriction for people with Type 1 diabetes. Cresswell, P., Krebs, J., Gilmour, J., et al.[2019]

Low-carbohydrate diets have been shown to effectively reduce high blood glucose levels in diabetes patients without the need for weight loss, and they can even lead to a reduction or elimination of diabetes medications.

The evidence suggests that low-carbohydrate diets should be considered as a primary treatment for type 2 diabetes and as a beneficial adjunct to medication for type 1 diabetes, with fewer side effects compared to commonly prescribed diabetic medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary carbohydrate restriction as the first approach in diabetes management: critical review and evidence base. Feinman, RD., Pogozelski, WK., Astrup, A., et al.[2022]

Low-carbohydrate diets have shown positive results in treating diabetes, pre-diabetes, metabolic syndrome, and obesity, with evidence from randomized trials and meta-analyses indicating they are safe and effective for improving health outcomes in diabetic patients.

These diets can lead to significant benefits such as weight loss, reduced medication needs, and even remission in some cases of type 2 diabetes, although they are not yet widely recognized in Czech diabetology due to ongoing safety concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-carbohydrate diet in diabetes mellitus treatment. Krejčí, H., Vyjídák, J., Kohutiar, M.[2019]

In a 16-week study involving 28 overweight participants with type 2 diabetes, the low-carbohydrate, ketogenic diet (LCKD) led to a significant 16% reduction in hemoglobin A1c levels, indicating improved glycemic control.

The diet also allowed for the discontinuation or reduction of diabetes medications in 17 out of 21 participants who completed the study, highlighting the need for close medical supervision when implementing such dietary changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A low-carbohydrate, ketogenic diet to treat type 2 diabetes. Yancy, WS., Foy, M., Chalecki, AM., et al.[2020]

A 42-year-old woman with type 2 diabetes experienced euglycemic diabetic ketoacidosis (euDKA) after starting a sodium-glucose co-transporter 2 (SGLT2) inhibitor while on a very low carbohydrate ketogenic diet (VLCKD), highlighting the risk of this combination.

After recovering from euDKA and stopping the SGLT2 inhibitor, she successfully resumed a VLCKD under medical supervision and maintained ketosis safely for 2 years, demonstrating that with proper monitoring, VLCKD can be safely reimplemented post-euDKA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SUCCESSFUL REIMPLEMENTATION OF A VERY LOW CARBOHYDRATE KETOGENIC DIET AFTER SGLT2 INHIBITOR ASSOCIATED EUGLYCEMIC DIABETIC KETOACIDOSIS. Fieger, EI., Fadel, KM., Modarres, AH., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12195831/

Low-Carb and Ketogenic Diets in Type 1 Diabetes In general, carbohydrate restriction enhances glycemic control by reducing postprandial glucose excursions, improving time-in-range, and lowering HbA1c.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36064937/

Very low carbohydrate (ketogenic) diets in type 2 diabetes A VLC/KD may cause reductions in HbA1c and triglycerides in those with pre-diabetes or T2D but evidence of an advantage over other strategies is limited.

3. diabetesjournals.org diabetesjournals.org/spectrum/article/33/2/133/32999/Low-Carbohydrate-and-Very-Low-Carbohydrate-Diets

Low-Carbohydrate and Very-Low-Carbohydrate Diets in ... This article reviews the differences between various low-carbohydrate eating plans and discusses the benefits and drawbacks of such a diet based on available ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2405457725001007

Low-carbohydrate diet in type 1 diabetes: A systematic ... In conclusion, evidence currently available in literature suggests some benefit of LC diets in the glycemic control of individuals living with T1D. While data ...

5. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0288440

Effects of a low-carbohydrate diet in adults with type 1 ... Collectively, the data suggests that LC diet may reduce hypoglycaemia and improve quality of life in individuals with T1D; however, further well ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40573112/

Low-Carb and Ketogenic Diets in Type 1 Diabetes In this narrative review, we discuss the available data regarding LCDs and KDs in both the adult and pediatric populations.

7. ccjm.org ccjm.org/content/88/10/547

Ketogenic diets in the management of type 1 diabetes The jury is still out on whether a low-carbohydrate, ketosis-inducing diet is an effective and safe adjunctive therapy to insulin in type 1 diabetes.

8. sciencedirect.com sciencedirect.com/science/article/pii/S0168822725004784

Effectiveness of low-carbohydrate diets on type 2 diabetes LCDs show modest 3-month glycemic improvements: 0.29% HbA1c reduction. · Cultural context significantly influences low-carb diet metabolic ...