Personalized Nutrition for Type 2 Diabetes
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to evaluate how personalized nutrition therapy, guided by continuous glucose monitors (CGM), can assist in managing type 2 diabetes. Participants will divide into groups: some will receive CGM plus nutrition advice, while others will use CGM alone, to compare outcomes. It targets individuals with type 2 diabetes who are not on insulin and have HbA1c levels between 6.8% and 8.5% (a common blood sugar test). As an unphased trial, this study provides a unique opportunity to explore innovative approaches to diabetes management.
Will I have to stop taking my current medications?
If you are taking insulin, sulfonylurea, meglitinide, or any non-diabetic medications that affect blood sugar, you cannot participate in the trial. Otherwise, the protocol does not specify if you need to stop other medications.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that continuous glucose monitoring (CGM) is generally safe for people with type 2 diabetes. Studies have found that CGM can improve blood sugar control. For instance, one study reported a significant decrease in HbA1c levels, indicating better long-term blood sugar management. Another study noted improvements in overall health and quality of life for those using CGM.
Nutrition therapy, a non-invasive method, involves changing diet based on CGM feedback. Previous studies have reported no major safety issues with this approach.
In summary, both CGM and nutrition therapy are considered safe and well-tolerated, with positive effects on blood sugar management and overall health.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores how personalized nutrition plans can work alongside continuous glucose monitoring (CGM) to manage Type 2 Diabetes more effectively. Unlike standard treatments like metformin or insulin, which primarily focus on regulating blood sugar through medication, this approach uses real-time data from CGM devices to tailor dietary advice specifically to the individual's needs. The trial is testing different combinations of CGM and nutrition therapy, both blinded and unblinded, to see which is most effective. By potentially offering a more customized, responsive way to manage blood sugar levels, this method could enhance patients' quality of life and reduce long-term complications associated with diabetes.
What evidence suggests that this trial's treatments could be effective for type 2 diabetes?
This trial will evaluate different approaches to using continuous glucose monitoring (CGM) and nutrition therapy for managing type 2 diabetes. Research has shown that combining CGM with personalized nutrition advice can help people with type 2 diabetes better control their blood sugar. One study found that individuals using CGM with tailored nutrition plans experienced a noticeable drop in their HbA1c levels, a measure of long-term blood sugar control. Another study demonstrated that real-time feedback from CGM helped people make healthier food choices and improve their overall blood sugar levels. Additionally, CGM use was linked to fewer severe low blood sugar episodes, making it a promising tool for managing diabetes. These findings suggest that combining CGM with nutrition advice may effectively manage type 2 diabetes. Participants in this trial will be assigned to different arms, including those receiving blinded or unblinded CGM with or without nutrition therapy, to assess the effectiveness of these combinations.36789
Who Is on the Research Team?
Anne Bantle
Principal Investigator
University of Minnesota
Are You a Good Fit for This Trial?
This trial is for individuals previously diagnosed with type 2 diabetes who have an HbA1c level between 6.8-8.5%. The study aims to include those who can benefit from personalized nutrition therapy based on continuous glucose monitoring.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive medical nutrition therapy personalized by continuous glucose monitor (CGM) feedback
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- CGM/Nutrition Therapy
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Minnesota
Lead Sponsor