Personalized Nutrition for Type 2 Diabetes
Personalized Nutrition Using Continuous Glucose Monitoring to Improve Outcomes in Type 2 Diabetes Mellitus
1 other identifier
interventional
72
1 country
1
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable type-2-diabetes
Started Jul 2025
Typical duration for not_applicable type-2-diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 14, 2025
CompletedFirst Posted
Study publicly available on registry
January 20, 2025
CompletedStudy Start
First participant enrolled
July 14, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2027
July 15, 2025
July 1, 2025
2 years
January 14, 2025
July 14, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hemoglobin A1c
Measure of blood glucose control
12 weeks
Study Arms (4)
Unblinded CGM/Nutrition Therapy
EXPERIMENTALBlinded CGM/Nutrition Therapy
EXPERIMENTALUnblinded CGM/No Nutrition Therapy
EXPERIMENTALBlinded CGM/No Nutrition Therapy
EXPERIMENTALInterventions
Personalized nutrition counseling based on CGM data
Standard nutrition education which does not incorporate CGM data
CGM and general diabetes education (no nutrition education)
General diabetes education (no nutrition education)
Eligibility Criteria
You may qualify if:
- at least 18 years of age
- previous diagnosis of T2DM
- HbA1c of 6.8-8.5%
You may not qualify if:
- 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."
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Minnesota
Minneapolis, Minnesota, 55455, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anne Bantle
University of Minnesota
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 14, 2025
First Posted
January 20, 2025
Study Start
July 14, 2025
Primary Completion (Estimated)
August 1, 2027
Study Completion (Estimated)
August 1, 2027
Last Updated
July 15, 2025
Record last verified: 2025-07