Type 2 DiabetesNCT06465693
Personalized Nutrition Therapy Using Continuous Glucose Monitoring to Improve Outcomes in Type 2 Diabetes Mellitus
A study testing Unblinded CGM plus nutrition therapy and Nutrition therapy only in people with Type 2 Diabetes, run by University of Minnesota at 1 site in United States.
Trial summary
Nutrition guidelines state that multiple eating patterns are effective for type 2 diabetes and that therapy should be individualized. Yet many nutrition plans fail to account for interpersonal variability in blood glucose response to meals. 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 plus nutrition therapy and Nutrition therapy only
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2024to 1 Jul 2026
- 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
- Have a previous diagnosis of type 2 diabetes
- HbA1c of 7.0 - 9.5%
- Stable medications for diabetes for at least 3 months prior to enrollment, with no plans to change medications or doses during the intervention period.
Who cannot join
- Type 1 diabetes
- Treatment with insulin, sulfonylurea, or meglitinide
- Use of a nondiabetic medication affecting blood glucose (e.g. corticosteroid)
- BMI <25 kg/m2
- Weight change \>5 pounds in the 3 months prior to enrollment
- Estimated glomerular filtration rate \<60 ml/minute/1.73 m2
Show all 9Show fewer
- Pregnant or breastfeeding
- Anemia (which affects HbA1c)
- Presence of any disease that would make adherence to the protocol difficult
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Nutrition guidelines state that multiple eating patterns are effective for type 2 diabetes and that therapy should be individualized. Yet many nutrition plans fail to account for interpersonal variability in blood glucose response to meals. This diminishes the ability of dietary interventions to optimize glycemic control and may lessen patient satisfaction, self--efficacy, and adherence. Continuous glucose monitoring (CGM) can facilitate behavior change in type 2 diabetes and has been associated with improved outcomes in nutrition intervention studies; this literature is limited by small study sample sizes and heterogeneity of study design and outcomes, and more data are needed. CGM could be a powerful tool for adapting a nutrition plan based on blood glucose response at an individual level. This study will test the use of CGM to personalize nutrition therapy compared to nutrition therapy alone (without CGM) for participants with type 2 diabetes who are not meeting glycemic treatment goals.
- Conditions
- Type 2 Diabetes
- Being tested
- Unblinded CGM plus nutrition therapy, Nutrition therapy only
- 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 plus nutrition therapyDevice
will receive evidence-based nutrition guidance by a certified and licensed registered dietitian (RD), including information on portion sizes, macronutrient types, and effect of carbohydrates on blood glucose.
will receive Dexcom G6 Pro CGMs to wear throughout the study. The CGM will be unblinded so that the glucose data will be available in real time to the participant and investigators. The dietitian and participant will review CGM data together
Nutrition therapy onlyBehavioural
will receive evidence-based nutrition guidance by a certified and licensed registered dietitian (RD), including information on portion sizes, macronutrient types, and effect of carbohydrates on blood glucose.
| Study group | Role | What they receive |
|---|---|---|
| Group1 | Experimental | After consent, screening, and a 10-day run-in period, eligible participants will be randomly assigned to unblinded CGM plus nutrition therapy Receives: Device: Unblinded CGM plus nutrition therapy |
| Group 2 | Active comparator | After consent, screening, and a 10-day run-in period, eligible participants will be randomly assigned to nutrition therapy only Receives: Behavioral: Nutrition therapy only |
What is being measured
The primary outcome is the main question the study is designed to answer.
HgbA1c
Measured: week 12
Secondary outcomes (13)
Glucose variability/coefficient of variation
using CGM data
Measured: week 12
mean glucose
using CGM data
Measured: week 12
time in range (glucose 70-180 mg/dl)
using CGM data
Measured: week 12
time above range (glucose 70-180 mg/dl)
using CGM data
Measured: week 12
Weight
Measured: week 12
Fasting plasma glucose
Measured: week 12
Fasting serum insulin
Measured: week 12
Serum lipid panel
Measured: week 12
Intervention Acceptability Questionnaire
Measured: week 12
Diabetes Treatment Satisfaction Questionnaire (DTSQ)
Measured: week 12
Diet Satisfaction Questionnaire (DSat-28)
Measured: week 12
Diabetes Management Self-Efficacy Scale (DMSES)
Measured: week 12
Medication Effect Score
Measured: week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2024
- Study start1 May 2024
- Primary completion14 Jul 2025
- Study completion1 Jul 2026 (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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- will compare CGM plus nutrition therapy to nutrition therapy only in participants with type 2 diabetes
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne Bantle, MD,MS, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06465693
- Sponsor's protocol ID
- MED-2023-32168
- Status last verified
- Jul 2025
- First submitted
- 13 Jun 2024
- Last updated
- 28 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Nutrition Therapy Using Continuous Glucose Monitoring to Improve Outcomes in Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT06465693
- Acronym / sponsor ID
- MED-2023-32168
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 14 Jul 2025 (actual)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 20 Jun 2024 (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.
Nutrition guidelines state that multiple eating patterns are effective for type 2 diabetes and that therapy should be individualized. Yet many nutrition plans fail to account for interpersonal variability in blood glucose response to meals. This diminishes the ability of dietary interventions to optimize glycemic control and may lessen patient satisfaction, self--efficacy, and adherence. Continuous glucose monitoring (CGM) can facilitate behavior change in type 2 diabetes and has been associated with improved outcomes in nutrition intervention studies; this literature is limited by small study sample sizes and heterogeneity of study design and outcomes, and more data are needed. CGM could be a powerful tool for adapting a nutrition plan based on blood glucose response at an individual level. This study will test the use of CGM to personalize nutrition therapy compared to nutrition therapy alone (without CGM) for participants with type 2 diabetes who are not meeting glycemic treatment goals.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- will compare CGM plus nutrition therapy to nutrition therapy only in participants with type 2 diabetes
| Arm | Type | Receives |
|---|---|---|
| Group1 | Experimental | Device: Unblinded CGM plus nutrition therapyAfter consent, screening, and a 10-day run-in period, eligible participants will be randomly assigned to unblinded CGM plus nutrition therapy |
| Group 2 | Active comparator | Behavioral: Nutrition therapy onlyAfter consent, screening, and a 10-day run-in period, eligible participants will be randomly assigned to nutrition therapy only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- At least 18 years of age
- Have a previous diagnosis of type 2 diabetes
- HbA1c of 7.0 - 9.5%
- Stable medications for diabetes for at least 3 months prior to enrollment, with no plans to change medications or doses during the intervention period.
Key exclusion criteria (9 listed)
- Type 1 diabetes
- Treatment with insulin, sulfonylurea, or meglitinide
- Use of a nondiabetic medication affecting blood glucose (e.g. corticosteroid)
- BMI <25 kg/m2
- Weight change \>5 pounds in the 3 months prior to 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 plus nutrition therapywill receive evidence-based nutrition guidance by a certified and licensed registered dietitian (RD), including information on portion sizes, macronutrient types, and effect of carbohydrates on blood glucose. will receive Dexcom G6 Pro CGMs to wear throughout the study. The CGM will be unblinded so that the glucose data will be available in real time to the participant and investigators. The dietitian and participant will review CGM data together | Device | Group1 |
| Nutrition therapy onlywill receive evidence-based nutrition guidance by a certified and licensed registered dietitian (RD), including information on portion sizes, macronutrient types, and effect of carbohydrates on blood glucose. | Behavioural | Group 2 |
Primary outcome
HgbA1c
Time frame: week 12
13 secondary outcomes
Glucose variability/coefficient of variation
Time frame: week 12
mean glucose
Time frame: week 12
time in range (glucose 70-180 mg/dl)
Time frame: week 12
time above range (glucose 70-180 mg/dl)
Time frame: week 12
Weight
Time frame: week 12
Fasting plasma glucose
Time frame: week 12
Fasting serum insulin
Time frame: week 12
Serum lipid panel
Time frame: week 12
Intervention Acceptability Questionnaire
Time frame: week 12
Diabetes Treatment Satisfaction Questionnaire (DTSQ)
Time frame: week 12
Diet Satisfaction Questionnaire (DSat-28)
Time frame: week 12
Diabetes Management Self-Efficacy Scale (DMSES)
Time frame: week 12
Medication Effect Score
Time frame: week 12
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 28 Jul 2025.
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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. This study is not recruiting at the moment.
Anne Bantle, MD,MS 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 plus nutrition therapy and Nutrition therapy only 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 4 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 28 Jul 2025. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HgbA1c (time frame: week 12). 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 28 Jul 2025; AzTrials last refreshed its copy on 7 Nov 2026.