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Personalized Nutrition for Type 2 Diabetes

NCT06784375 · University of Minnesota
In plain English

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Official title
Personalized Nutrition Using Continuous Glucose Monitoring to Improve Outcomes in Type 2 Diabetes Mellitus
About this study
This project will compare medical nutrition therapy personalized by continuous glucose monitor (CGM) feedback to control interventions in participants with type 2 diabetes mellitus (T2DM).
Eligibility criteria
Inclusion Criteria: * at least 18 years of age * previous diagnosis of T2DM * HbA1c of 6.8-8.5% Exclusion Criteria: * type 1 diabetes mellitus * treatment with insulin, sulfonylurea, or meglitinide * use of nondiabetic medications that affect blood glucose control (such as corticosteroids) * BMI \<25 kg/m2 or \<23 kg/m2 for participants who self-identify as Asian * weight change \>5 pounds in the 3 months prior to study enrollment * estimated glomerular filtration rate \<60 ml/minute/1.73 m2 * pregnancy or immediate plans to become pregnant 8) breastfeeding 9) anemia (which would affect measurement of HbA1c) 10) changes to glucose lowering medications, including change in dose, in the 3 months prior to enrollment 11) presence of any disease that would make adherence to the protocol difficult."
Study design
Enrollment target: 72 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-07-14
Estimated completion: 2027-08-01
Last updated: 2025-07-15
Interventions
Behavioral: Unblinded CGM/Nutrition TherapyBehavioral: Blinded CGM/Nutrition TherapyBehavioral: Unblinded CGM/No Nutrition TherapyBehavioral: Blinded CGM/No Nutrition Therapy
Primary outcomes
  • Hemoglobin A1c (12 weeks)
Sponsor
University of Minnesota · other
Contacts & investigators
ContactAnne Bantle · contact · bant0015@umn.edu · 612-625-8673
InvestigatorAnne Bantle · principal_investigator, University of Minnesota
All locations (1)
University of MinnesotaRecruiting
Minneapolis, Minnesota, United States