Study Results
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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RECRUITING
NA
72 participants
INTERVENTIONAL
2025-07-14
2027-08-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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Unblinded CGM/Nutrition Therapy
Unblinded CGM/Nutrition Therapy
Personalized nutrition counseling based on CGM data
Blinded CGM/Nutrition Therapy
Blinded CGM/Nutrition Therapy
Standard nutrition education which does not incorporate CGM data
Unblinded CGM/No Nutrition Therapy
Unblinded CGM/No Nutrition Therapy
CGM and general diabetes education (no nutrition education)
Blinded CGM/No Nutrition Therapy
Blinded CGM/No Nutrition Therapy
General diabetes education (no nutrition education)
Interventions
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Unblinded CGM/Nutrition Therapy
Personalized nutrition counseling based on CGM data
Blinded CGM/Nutrition Therapy
Standard nutrition education which does not incorporate CGM data
Unblinded CGM/No Nutrition Therapy
CGM and general diabetes education (no nutrition education)
Blinded CGM/No Nutrition Therapy
General diabetes education (no nutrition education)
Eligibility Criteria
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Inclusion Criteria
* previous diagnosis of T2DM
* HbA1c of 6.8-8.5%
Exclusion Criteria
* 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."
18 Years
ALL
No
Sponsors
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University of Minnesota
OTHER
Responsible Party
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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
Countries
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Central Contacts
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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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