Personalized Nutrition Therapy Using Continuous Glucose Monitoring to Improve Outcomes in Type 2 Diabetes Mellitus

University of Minnesota (UMN)

Status: Enrolling

Conditions: Type 2 Diabetes

Treatments: Behavioral: Nutrition therapy only; Device: Unblinded CGM plus nutrition therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06465693

MED-2023-32168

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• At least 18 years of age
• Have a previous diagnosis of type 2 diabetes
• HbA1c of 7.0 - 9.5%
• Stable medications for diabetes for at least 3 months prior to enrollment, with no plans to change medications or doses during the intervention period.

Exclusion criteria

• Type 1 diabetes
• Treatment with insulin, sulfonylurea, or meglitinide
• Use of a nondiabetic medication affecting blood glucose (e.g. corticosteroid)
• BMI <25 kg/m2
• Weight change &gt;5 pounds in the 3 months prior to enrollment
• Estimated glomerular filtration rate &lt;60 ml/minute/1.73 m2
• Pregnant or breastfeeding
• Anemia (which affects HbA1c)
• Presence of any disease that would make adherence to the protocol difficult

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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10 participants in 2 patient groups

Group1

Experimental group

Description:

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

Treatment:

Device: Unblinded CGM plus nutrition therapy

Group 2

Active Comparator group

Description:

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

Treatment:

Behavioral: Nutrition therapy only