Personalized Nutrition Therapy for Type 2 Diabetes

Overseen By Anne Bantle, MD, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Minnesota

Must not be taking: Insulin, Sulfonylurea, Meglitinide, Corticosteroid

Disqualifiers: Type 1 diabetes, Anemia, Pregnancy, others

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

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

10 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that your diabetes medications have been stable for at least 3 months before joining, and you should not plan to change them during the study. If you are on insulin, sulfonylurea, or meglitinide, you cannot participate.

What data supports the effectiveness of the treatment Personalized Nutrition Therapy Using Continuous Glucose Monitoring for Type 2 Diabetes?

Research shows that using continuous glucose monitoring (CGM) to provide personalized nutritional advice can improve blood sugar control and enhance well-being in people with type 2 diabetes. Personalized recommendations based on individual responses to food help manage blood sugar levels more effectively than generic dietary advice. ^{1 2 3 4 5}

Is Personalized Nutrition Therapy using Continuous Glucose Monitoring safe for humans?

Continuous Glucose Monitoring (CGM) has been shown to be safe and beneficial for people with diabetes, helping to manage blood sugar levels and improve quality of life. It reduces risks of both low and high blood sugar and is used in various treatment settings, indicating its general safety in humans. ^{1 2 6 7 8}

How is Personalized Nutrition Therapy Using Continuous Glucose Monitoring different from other treatments for type 2 diabetes?

This treatment is unique because it uses continuous glucose monitoring (CGM) to provide real-time feedback on blood sugar levels, allowing for personalized dietary adjustments based on individual glucose responses. This approach helps tailor nutrition therapy to each person's specific needs, potentially improving blood sugar control more effectively than standard dietary recommendations. ^{1 2 5 9 10}

What is the purpose of this trial?

Nutrition guidelines state that multiple eating patterns are effective for type 2 diabetes and that therapy should be individualized. Yet many nutrition plans fail to account for interpersonal variability in blood glucose response to meals. This diminishes the ability of dietary interventions to optimize glycemic control and may lessen patient satisfaction, self--efficacy, and adherence. Continuous glucose monitoring (CGM) can facilitate behavior change in type 2 diabetes and has been associated with improved outcomes in nutrition intervention studies; this literature is limited by small study sample sizes and heterogeneity of study design and outcomes, and more data are needed. CGM could be a powerful tool for adapting a nutrition plan based on blood glucose response at an individual level. This study will test the use of CGM to personalize nutrition therapy compared to nutrition therapy alone (without CGM) for participants with type 2 diabetes who are not meeting glycemic treatment goals.

Research Team

Anne Bantle, MD,MS

Principal Investigator

University of Minnesota

Eligibility Criteria

This trial is for individuals with Type 2 Diabetes who are not currently meeting their blood sugar control goals. It's designed to see if personalized nutrition advice using continuous glucose monitoring (CGM) helps better than standard nutrition therapy alone.

Inclusion Criteria

My diabetes medication has been stable for 3 months and I don't plan to change it.

HbA1c of 7.0 - 9.5%

I have been diagnosed with type 2 diabetes.

Exclusion Criteria

I am being treated with insulin or certain diabetes medications.

Weight change >5 pounds in the 3 months prior to enrollment

I have Type 1 diabetes.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Run-in

Participants undergo a 10-day run-in period before randomization

1.5 weeks

Treatment

Participants receive either CGM plus nutrition therapy or nutrition therapy alone

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Personalized Nutrition Therapy Using Continuous Glucose Monitoring

Trial Overview Participants will either receive a combination of CGM and tailored nutrition therapy or just the standard nutrition guidance without CGM. The goal is to determine if real-time blood sugar tracking can improve dietary plans and diabetes outcomes.

Participant Groups

Group I: Group1 Experimental Treatment 1 Intervention

After consent, screening, and a 10-day run-in period, eligible participants will be randomly assigned to unblinded CGM plus nutrition therapy

Group II: Group 2 Active Control 1 Intervention

After consent, screening, and a 10-day run-in period, eligible participants will be randomly assigned to nutrition therapy only

Personalized Nutrition Therapy Using Continuous Glucose Monitoring is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Continuous Glucose Monitoring for:

• Type 1 diabetes
• Type 2 diabetes

Approved in European Union as Continuous Glucose Monitoring for:

• Type 1 diabetes
• Type 2 diabetes

Approved in Canada as Continuous Glucose Monitoring for:

• Type 1 diabetes
• Type 2 diabetes

Approved in Japan as Continuous Glucose Monitoring for:

• Type 1 diabetes
• Type 2 diabetes

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Findings from Research

Nutritional therapies are essential for managing both type 1 and type 2 diabetes, as well as for individuals with prediabetes or obesity, emphasizing the need for personalized dietary plans.

Continuous glucose monitoring (CGM) systems, particularly through the ambulatory glucose profile (AGP), can enhance nutritional therapy by providing valuable data to tailor dietary adjustments based on individual glycaemic responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

AGP and Nutrition - Analysing postprandial glucose courses with CGM. Kröger, J., Siegmund, T., Schubert-Olesen, O., et al.[2021]

In a study involving 154 participants with type 2 diabetes, 28 days of home-delivered, pre-portioned meals led to a significant improvement in glycemic control, with a 6.8% increase in time in range (TIR) and a 0.21% decrease in glucose management index (GMI).

The improvements in glycemic control were short-lived, as TIR regressed after the meal delivery period ended, suggesting that ongoing support or interventions may be necessary to maintain these benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved Time in Range During 28 Days of Meal Delivery for People With Type 2 Diabetes. Clark, CN., Hart, BB., McNeil, CK., et al.[2022]

Personalized nutritional recommendations based on continuous glucose monitoring (CGM) significantly improved glycaemic control in individuals with type 2 diabetes (T2D), highlighting the importance of tailored dietary advice over generic guidelines.

Participants showed notable reductions in post-prandial glucose levels and reported enhanced well-being, including better energy levels and concentration, suggesting that personalized nutrition can effectively support non-pharmaceutical management of T2D.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personalised Nutritional Recommendations Based on Individual Post-Prandial Glycaemic Responses Improve Glycaemic Metrics and PROMs in Patients with Type 2 Diabetes: A Real-World Assessment. Ungersboeck, M., Tang, X., Neeff, V., et al.[2022]

Continuous glucose monitors (CGMs) have been shown to significantly improve metabolic control and reduce hypoglycemia in adults with diabetes, based on large clinical trials.

Data supporting the benefits of CGMs in children and adolescents is less robust, indicating a need for further research, especially regarding insulin dosing algorithms and their effectiveness in younger populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous glucose monitoring in type 1 diabetes. Mauras, N., Fox, L., Englert, K., et al.[2021]

The China Medical Nutrition Therapy Guideline for Diabetes, developed in 2010, provides evidence-based recommendations for nutritional therapy in diabetes management, addressing both prevention and treatment.

These guidelines aim to enhance the quality of life for individuals with diabetes and reduce the complications associated with the disease by applying scientific criteria to nutritional interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Development and interpretation of China medical nutrition therapy guideline for diabetes (2010)]. Chen, W., Jiang, H., Tao, YX., et al.[2011]

Continuous glucose monitoring (CGM) has the potential to revolutionize diabetes care, especially when integrated into automated, closed-loop glucose control systems, despite current limitations in CGM device accuracy.

By using algorithms that maintain blood glucose levels slightly above normal, closed-loop systems can help achieve hemoglobin A1c targets while reducing the risk of hypoglycemia, benefiting not only diabetes patients but also those in intensive care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous glucose monitoring awaits its "killer app". Russell, SJ.[2021]

Continuous glucose monitoring (CGM) was found to be feasible and acceptable for 27 non-insulin-using adults with type 2 diabetes, with 82% accurately logging their dietary and exercise events despite some difficulties in entering data.

CGM provided valuable insights, identifying 141 dietary and 71 exercise-teaching events, indicating its potential to enhance behavioral interventions for managing diabetes, even though some participants experienced minor discomfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous glucose monitoring in non-insulin-using individuals with type 2 diabetes: acceptability, feasibility, and teaching opportunities. Allen, NA., Fain, JA., Braun, B., et al.[2022]

Continuous Glucose Monitoring (CGM) significantly reduces the risks of hypoglycemia and hyperglycemia, improves glycemic variability, and enhances the quality of life for patients with both type 1 and type 2 diabetes, as evidenced by its clinical value across various treatment regimens.

A new CGM device has been approved for self-adjustment of insulin dosages and reimbursement in the U.S., demonstrating an accuracy of approximately 10% and showing that CGM can effectively support both multiple daily injections and continuous insulin infusion methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous Glucose Monitoring: A Review of Recent Studies Demonstrating Improved Glycemic Outcomes. Rodbard, D.[2022]

Medical nutrition therapy for diabetes should be personalized, taking into account individual eating habits, metabolic profiles, and treatment goals to optimize health outcomes.

Regular monitoring of metabolic parameters like glucose levels, HbA1c, and body weight is crucial for adjusting therapy and ensuring effective management of diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

American Diabetes Association position statement: evidence-based nutrition principles and recommendations for the treatment and prevention of diabetes and related complications. [2022]

Medical nutrition therapy (MNT) has been shown to effectively improve glycemic control and help maintain a healthy weight in individuals with type 2 diabetes, as demonstrated in two case studies.

The combination of a personalized diet and coaching support from certified experts can significantly reduce cardiovascular risk factors, highlighting the importance of tailored nutrition programs in diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Meaningful Effects of a Personalized Nutrition and Coaching Program for Type 2 Diabetes Mellitus: Two Case Reports. Unverdorben, S.[2023]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

AGP and Nutrition - Analysing postprandial glucose courses with CGM. [2021]

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

Improved Time in Range During 28 Days of Meal Delivery for People With Type 2 Diabetes. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Personalised Nutritional Recommendations Based on Individual Post-Prandial Glycaemic Responses Improve Glycaemic Metrics and PROMs in Patients with Type 2 Diabetes: A Real-World Assessment. [2022]

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

Continuous glucose monitoring in type 1 diabetes. [2021]

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

[Development and interpretation of China medical nutrition therapy guideline for diabetes (2010)]. [2011]

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

Continuous glucose monitoring awaits its "killer app". [2021]

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

Continuous glucose monitoring in non-insulin-using individuals with type 2 diabetes: acceptability, feasibility, and teaching opportunities. [2022]

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

Continuous Glucose Monitoring: A Review of Recent Studies Demonstrating Improved Glycemic Outcomes. [2022]

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

American Diabetes Association position statement: evidence-based nutrition principles and recommendations for the treatment and prevention of diabetes and related complications. [2022]

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

The Meaningful Effects of a Personalized Nutrition and Coaching Program for Type 2 Diabetes Mellitus: Two Case Reports. [2023]