Personalized Nutrition for Type 2 Diabetes

NCT ID: NCT06784375

Last Updated: 2025-07-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-14

Study Completion Date

2027-08-01

Brief Summary

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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).

Detailed Description

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Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Prospective Randomized Trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Unblinded CGM/Nutrition Therapy

Group Type EXPERIMENTAL

Unblinded CGM/Nutrition Therapy

Intervention Type BEHAVIORAL

Personalized nutrition counseling based on CGM data

Blinded CGM/Nutrition Therapy

Group Type EXPERIMENTAL

Blinded CGM/Nutrition Therapy

Intervention Type BEHAVIORAL

Standard nutrition education which does not incorporate CGM data

Unblinded CGM/No Nutrition Therapy

Group Type EXPERIMENTAL

Unblinded CGM/No Nutrition Therapy

Intervention Type BEHAVIORAL

CGM and general diabetes education (no nutrition education)

Blinded CGM/No Nutrition Therapy

Group Type EXPERIMENTAL

Blinded CGM/No Nutrition Therapy

Intervention Type BEHAVIORAL

General diabetes education (no nutrition education)

Interventions

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Unblinded CGM/Nutrition Therapy

Personalized nutrition counseling based on CGM data

Intervention Type BEHAVIORAL

Blinded CGM/Nutrition Therapy

Standard nutrition education which does not incorporate CGM data

Intervention Type BEHAVIORAL

Unblinded CGM/No Nutrition Therapy

CGM and general diabetes education (no nutrition education)

Intervention Type BEHAVIORAL

Blinded CGM/No Nutrition Therapy

General diabetes education (no nutrition education)

Intervention Type BEHAVIORAL

Eligibility Criteria

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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."
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anne Bantle

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

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University of Minnesota

Minneapolis, Minnesota, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Anne Bantle

Role: CONTACT

612-625-8673

Facility Contacts

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Anne Bantle

Role: primary

Other Identifiers

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MED-2024-31907

Identifier Type: -

Identifier Source: org_study_id

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