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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if continuous glucose monitoring (CGM) can help create a personalized nutrition plan for people with type 2 diabetes. Researchers seek to discover whether CGM can simplify blood sugar control compared to following a standard nutrition plan. The trial includes two groups: one using CGM with nutrition therapy and the other using only nutrition therapy. This study suits individuals diagnosed with type 2 diabetes who have stable medication routines and have struggled to meet their blood sugar goals. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance diabetes management for many.

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 prior data suggests that this method is safe for personalizing nutrition therapy?

Research has shown that using Continuous Glucose Monitoring (CGM) to guide personalized nutrition plans is generally safe for people with type 2 diabetes. Studies have found that CGM provides real-time updates on blood sugar levels, aiding individuals in making better food choices. No major safety issues have been reported with this method. Most participants in these studies found the treatment easy to manage, with few side effects. This makes CGM a promising tool for managing diabetes through personalized nutrition. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Personalized Nutrition Therapy for Type 2 Diabetes because it uses continuous glucose monitoring (CGM) to tailor dietary recommendations specifically for each person. Unlike traditional methods that rely on generalized diet plans, this approach provides real-time glucose data, allowing for more precise adjustments to an individual's nutrition. This could lead to better blood sugar control and potentially reduce the need for medications, offering a personalized and proactive way to manage diabetes.

What evidence suggests that CGM-based nutrition therapy is effective for type 2 diabetes?

Research has shown that using continuous glucose monitoring (CGM) to guide personalized nutrition can help people with type 2 diabetes better control their blood sugar. In this trial, one group of participants will receive unblinded CGM plus nutrition therapy, while another group will receive only nutrition therapy. Studies have found that real-time feedback from CGM helps people make healthier food choices, leading to improved blood sugar management. Some evidence suggests that this method can lower HbA1c levels, an important measure of long-term blood sugar control. It may also enhance the pancreas's ability to produce insulin, crucial for managing diabetes. Overall, CGM-guided nutrition therapy shows promise for improving diabetes care by providing dietary advice tailored to each person's needs. ^{1 2 3 5 6}

Who Is on the Research Team?

Anne Bantle, MD,MS

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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) 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]

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]

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]

Citations

1. reporter.nih.gov reporter.nih.gov/search/-YORzSfMKUmNeq29WzKwFA/project-details/11047306

Personalized Nutrition Using Continuous Glucose Monitoring ... The central hypothesis is that CGM-informed personalized nutrition therapy is superior to improve glycemic control in T2DM compared to medical nutrition therapy ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06784375

NCT06784375 | Personalized Nutrition for Type 2 Diabetes This project will compare medical nutrition therapy personalized by continuous glucose monitor (CGM) feedback to control interventions in participants with type ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06465693/personalized-nutrition-therapy-using-continuous-glucose-monitoring-to-improve-outcomes-in-type-2-diabetes-mellitus

Personalized Nutrition Therapy Using Continuous Glucose ... This study will test the use of CGM to personalize nutrition therapy compared to nutrition therapy alone (without CGM) for participants with ...

4. publichealth.gmu.edu publichealth.gmu.edu/news/2025-11/research-precision-nutrition-specialist-supports-evidence-based-policy-efforts

Research by a precision nutrition specialist supports evidence ... CGM provides real-time feedback on blood glucose levels. Access to real-time feedback empowers individuals to sustain positive nutritional ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39634180/

Personalized nutrition in type 2 diabetes remission The DT-driven personalized nutrition plan has been associated with reductions in HbA1c, enhanced beta-cell function, and normalization of ...

6. diabetesjournals.org diabetesjournals.org/clinical/article/43/4/610/158237/Continuous-Glucose-Monitoring-CGM-as-a-Behavior

A Case Series on CGM-Guided Nutrition in People With Type ... Continuous Glucose Monitoring (CGM) as a Behavior Modification Tool: A Case Series on CGM-Guided Nutrition in People With Type 2 Diabetes Not ...