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

Last updated: July 24, 2025
Sponsor: University of Minnesota
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Diabetes Prevention

Diabetes Mellitus, Type 2

Diabetes Mellitus Types I And Ii

Treatment

Unblinded CGM plus nutrition therapy

Nutrition therapy only

Clinical Study ID

NCT06465693
MED-2023-32168
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 noplans to change medications or doses during the intervention period.

Exclusion

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

Study Design

Total Participants: 8
Treatment Group(s): 2
Primary Treatment: Unblinded CGM plus nutrition therapy
Phase:
Study Start date:
May 01, 2024
Estimated Completion Date:
July 01, 2026

Connect with a study center

  • University of Minnesota

    Minneapolis, Minnesota 55455
    United States

    Site Not Available

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