Type 2 DiabetesNCT06784375
Individualized Diabetes Education Assisted by CGM (IDEA-CGM)
A study testing Unblinded CGM/Nutrition Therapy, Blinded CGM/Nutrition Therapy and Unblinded CGM/No Nutrition Therapy in people with Type 2 Diabetes, run by University of Minnesota at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Unblinded CGM/Nutrition Therapy, Blinded CGM/Nutrition Therapy and Unblinded CGM/No Nutrition Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jul 2025to 15 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- at least 18 years of age
- previous diagnosis of T2DM
- HbA1c of 6.8-8.5%
Who cannot join
- 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."
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
Anne Bantle
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).
- Conditions
- Type 2 Diabetes
- Being tested
- Unblinded CGM/Nutrition Therapy, Blinded CGM/Nutrition Therapy, Unblinded CGM/No Nutrition Therapy, Blinded CGM/No Nutrition Therapy
- Keywords
- Type 2 Diabetes, Nutrition, CGM
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unblinded CGM/Nutrition TherapyBehavioural
Personalized nutrition counseling based on CGM data
Blinded CGM/Nutrition TherapyBehavioural
Standard nutrition education which does not incorporate CGM data
Unblinded CGM/No Nutrition TherapyBehavioural
CGM and general diabetes education (no nutrition education)
Blinded CGM/No Nutrition TherapyBehavioural
General diabetes education (no nutrition education)
| Study group | Role | What they receive |
|---|---|---|
| Unblinded CGM/Nutrition Therapy | Experimental | Not described Receives: Behavioral: Unblinded CGM/Nutrition Therapy |
| Blinded CGM/Nutrition Therapy | Experimental | Not described Receives: Behavioral: Blinded CGM/Nutrition Therapy |
| Unblinded CGM/No Nutrition Therapy | Experimental | Not described Receives: Behavioral: Unblinded CGM/No Nutrition Therapy |
| Blinded CGM/No Nutrition Therapy | Experimental | Not described Receives: Behavioral: Blinded CGM/No Nutrition Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1c
Measure of blood glucose control
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start14 Jul 2025
- Primary completion15 Sep 2027 (estimated)
- Study completion15 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Prospective Randomized Trial
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne Bantle, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06784375
- Sponsor's protocol ID
- MED-2024-31907
- Status last verified
- Jul 2026
- First submitted
- 14 Jan 2025
- Last updated
- 16 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualized Diabetes Education Assisted by CGM (IDEA-CGM)
- ClinicalTrials.gov ID
- NCT06784375
- Acronym / sponsor ID
- MED-2024-31907
- Conditions
- Type 2 Diabetes
- Keywords
- Type 2 Diabetes, Nutrition, CGM
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 14 Jul 2025 (actual)
- Primary completion
- 15 Sep 2027 (estimated)
- Study completion
- 15 Sep 2027 (estimated)
- First posted
- 20 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Prospective Randomized Trial
| Arm | Type | Receives |
|---|---|---|
| Unblinded CGM/Nutrition Therapy | Experimental | Behavioral: Unblinded CGM/Nutrition Therapy |
| Blinded CGM/Nutrition Therapy | Experimental | Behavioral: Blinded CGM/Nutrition Therapy |
| Unblinded CGM/No Nutrition Therapy | Experimental | Behavioral: Unblinded CGM/No Nutrition Therapy |
| Blinded CGM/No Nutrition Therapy | Experimental | Behavioral: Blinded CGM/No Nutrition Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- at least 18 years of age
- previous diagnosis of T2DM
- HbA1c of 6.8-8.5%
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Unblinded CGM/Nutrition TherapyPersonalized nutrition counseling based on CGM data | Behavioural | Unblinded CGM/Nutrition Therapy |
| Blinded CGM/Nutrition TherapyStandard nutrition education which does not incorporate CGM data | Behavioural | Blinded CGM/Nutrition Therapy |
| Unblinded CGM/No Nutrition TherapyCGM and general diabetes education (no nutrition education) | Behavioural | Unblinded CGM/No Nutrition Therapy |
| Blinded CGM/No Nutrition TherapyGeneral diabetes education (no nutrition education) | Behavioural | Blinded CGM/No Nutrition Therapy |
Primary outcome
Hemoglobin A1c
Time frame: 12 weeks
Measure of blood glucose control
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anne Bantle principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unblinded CGM/Nutrition Therapy, Blinded CGM/Nutrition Therapy and Unblinded CGM/No Nutrition Therapy in people with Type 2 Diabetes, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anne Bantle (612-625-8673, bant0015@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin A1c (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.