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Recruiting NCT06784375

Individualized Diabetes Education Assisted by CGM (IDEA-CGM)

No phase Interventional Type 2 Diabetes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Unblinded CGM/Nutrition Therapy, Blinded CGM/Nutrition Therapy, Unblinded CGM/No Nutrition Therapy, Blinded CGM/No Nutrition Therapy.
Who it may be relevant to
Registry conditions: Type 2 Diabetes. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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).

Interventions

  • Behavioral Unblinded CGM/Nutrition Therapy
    Personalized nutrition counseling based on CGM data
  • Behavioral Blinded CGM/Nutrition Therapy
    Standard nutrition education which does not incorporate CGM data
  • Behavioral Unblinded CGM/No Nutrition Therapy
    CGM and general diabetes education (no nutrition education)
  • Behavioral Blinded CGM/No Nutrition Therapy
    General diabetes education (no nutrition education)

Primary outcome measures

  • Hemoglobin A1c [Time frame: 12 weeks]

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."

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Factorial
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Minnesota — Minneapolis

Identifiers

NCT: NCT06784375 · MED-2024-31907

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗