Continuous Glucose Monitor + Nutrition Counseling for Type 2 Diabetes
(ALIGN Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether continuous glucose monitors (CGMs) combined with nutrition counseling can help people with type 2 diabetes manage blood sugar and improve eating habits. Researchers aim to determine if real-time glucose monitoring and nutritional advice offer greater benefits than focusing solely on diet. Individuals with type 2 diabetes who struggle with healthy eating due to food or nutrition insecurity and have not used a CGM in the last six months may be suitable for this study. Participants will be divided into two groups, with one group using the CGM and receiving counseling during the first part of the trial. As an unphased trial, this study provides a unique opportunity to contribute to innovative diabetes management strategies.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but if you are on a GLP-1 RA medication, it must be stable for at least 1 month before joining, and you shouldn't change the dose during the study.
What prior data suggests that this continuous glucose monitor-augmented intervention is safe for adults with type 2 diabetes?
Research shows that continuous glucose monitors (CGMs) are generally safe and offer clear benefits for people with diabetes. Studies indicate that CGMs can guide lifestyle choices, particularly in eating habits. They help users make healthier food choices by displaying real-time blood sugar levels.
The American Diabetes Association (ADA) recommends CGMs for anyone with diabetes who uses insulin or experiences low blood sugar issues. This endorsement suggests that CGMs are both safe and helpful.
Although specific safety data for the CGM-augmented food is medicine (FIM) intervention is limited, CGMs themselves are well-tolerated. Most people find them easy to use and beneficial for managing diabetes. Joining this trial could provide a safe way to better understand and manage blood sugar levels through both technology and nutrition counseling.12345Why are researchers excited about this trial?
Researchers are excited about the CGM-Augmented Food Is Medicine approach because it combines continuous glucose monitoring (CGM) with personalized nutrition counseling to manage Type 2 Diabetes. Unlike standard treatments that often rely on medication and generic dietary advice, this method provides real-time data and tailored dietary guidance, potentially leading to better blood sugar control. This innovative approach could empower patients by giving them immediate feedback and a more personalized plan, which might improve adherence and outcomes.
What evidence suggests that this CGM-augmented food is medicine intervention is effective for type 2 diabetes?
This trial will compare two approaches for managing type 2 diabetes: one group will receive nutrition counseling alone, while another will receive a combination of continuous glucose monitoring (CGM) and nutrition counseling. Research has shown that using a CGM helps people with type 2 diabetes manage their blood sugar more effectively. Studies have found that CGM use can significantly lower A1c levels, an important measure of long-term blood sugar control. When combined with nutrition counseling, this method may also improve healthy eating habits. Unlike traditional methods like finger-prick testing, CGMs provide real-time feedback, helping people make better daily choices about food and activity. This combination of real-time monitoring and guidance can be especially beneficial for those who find diet and nutrition challenging.26789
Who Is on the Research Team?
Anna Kahkoska, MD, PhD
Principal Investigator
University of North Carolina, Chapel Hill
Are You a Good Fit for This Trial?
This trial is for adults with type 2 diabetes who struggle with nutrition or food insecurity. Participants should be interested in improving their diet and managing their blood sugar levels. Specific eligibility details are not provided, but typically participants must meet certain health criteria to join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Intervention
Participants are randomized to either the CGM-augmented FIM intervention or standard FIM intervention for 12 weeks. The intervention includes real-time CGM and nutrition counseling.
Extension
All participants receive both FIM and real-time CGM for self-directed use.
Follow-up
Participants are monitored for safety and effectiveness after the extension phase.
What Are the Treatments Tested in This Trial?
Interventions
- CGM-Augmented Food Is Medicine
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of North Carolina, Chapel Hill
Lead Sponsor
American Heart Association
Collaborator