Type 2 DiabetesGEMNCT05766735
Treating Early Type 2 Diabetes by Reducing Postprandial Glucose Excursions: A Paradigm Shift in Lifestyle Modification
A study testing Routine Care + Glycemic Excursion Minimization (RC+GEM) and Routine Care (RC) in people with Type 2 Diabetes, run by Chiara Fabris, PhD at 2 sites in United States.
Trial summary
A Randomized Control Trial (RCT) with 1:1 randomization of adults newly diagnosed with type 2 diabetes (T2D) to Routine Care (RC) and RC + Glycemic Excursion Minimization (RC+GEM); a program that provides RC in addition to continuous glucose monitors (CGM) within a structured, self-directed, and personalized lifestyle… Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Routine Care + Glycemic Excursion Minimization (RC+GEM) and Routine Care (RC)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Aug 2023to 31 May 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis, based on investigator assessment, of type 2 diabetes within the past 24 months
- Age ≥30.0 and ≤80 years
- Hemoglobin A1c = ≥6.5-≤11% (medical record value <6 month-old is acceptable)
- Access to smartphone throughout the study
- Diabetes management visit with medical provider within 12 months of screening date
- If on weight altering medications (e.g., GLP-1, GIP), on a stable dose for about four weeks
Who cannot join
- Medications that impede weight loss within the last 3 months, per study physicians' discretion
- Any psychotropic medication that could raise blood glucose, per study physicians' opinion
- Conditions that preclude participating in the study (e.g., severe mental disease like manic depressive illness, severe depression, active substance abuse)
- Conditions that preclude increasing physical activity (e.g., severe neuropathy, cardiovascular disease, COPD/emphysema, severe osteoarthritis, stroke)
- Conditions that prevent doing the self-directed GEM program, such as inability to read English, mental health conditions that prevent engagement in treatment, such as active substance abuse, severe depression
- Conditions that restrict diet such as severe gastroparesis, ulcers, or food allergies
Show all 12Show fewer
- Severe vision impairment that at PI discretion would preclude ability to read the GEM manual or see the information on the CGM or activity tracker
- Currently undergoing treatment for cancer that in the opinion of the PI would preclude participation in the study
- Renal impairment (for example eGFR < 45 mL/min/1.73 meters squared; CKD-3b)
- Currently pregnant or contemplating pregnancy within the next 14 months
- Currently breastfeeding
- Any condition that, in the opinion of the principal investigator, could interfere with the safe and effective completion of the study.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
University of Colorado Department of Family Medicine
Aurora, Colorado, 80045
Tamara K. Oser, MD, 303-724-2060, tamara.oser@cuanschutz.edu
Britney Prince, 303-724-8968, britney.prince@cuanschutz.edu
- Recruiting
University of Virginia Center for Diabetes Technology
Charlottesville, Virginia, 22903
Chiara Fabris, PhD, 434-982-6483, cf9qe@virginia.edu
Jacqueline Rodriguez, 434-422-2653, ZMT8XG@uvahealth.org
About this study
A Randomized Control Trial (RCT) with 1:1 randomization of adults newly diagnosed with type 2 diabetes (T2D) to Routine Care (RC) and RC + Glycemic Excursion Minimization (RC+GEM); a program that provides RC in addition to continuous glucose monitors (CGM) within a structured, self-directed, and personalized lifestyle program called GEM. Our hypothesis is that RC+GEM will: 1) reduce hemoglobin A1c as much or more, 2) require less diabetes medication, 3) cost less, and 4) have more secondary benefits, (e.g. greater reduction in cardiovascular risk, weight, diabetes distress, depression symptoms), compared to RC alone.
Read the detailed description
The proposed study will compare individualized self-administered versions of RC+GEM to RC among patients recently diagnosed with type 2 diabetes. We hypothesize that, compared to RC alone, RC+GEM will be at least as effective at improving blood glucose control (A1c), and RC+GEM will do so with less reliance on diabetes medication and with greater secondary benefits such as lower risk of cardiovascular disease, more "good" cholesterol (HDL), greater weight loss, a greater sense of empowerment, and fewer diabetes-related expenses. It is further hypothesized that these benefits will be sustained over 13.5-months of follow-up with no structured maintenance program.
Remote study visits are permitted. Clinic visit and remote visits may include videoconferencing, phone, text messages and emails.
- Conditions
- Type 2 Diabetes
- Being tested
- Routine Care + Glycemic Excursion Minimization (RC+GEM), Routine Care (RC)
- Keywords
- Routine Care (RC), Routine Care + Glycemic Excursion Minimization (RC+GEM), Continuous Glucose Monitor (CGM), Randomized Controlled Trial (RCT), Blood Glucose (BG), Newly Diagnosed Type 2 Diabetes, Type 2 diabetes (T2D), Primary Care Provider (PCP), Remote Study Visits
- 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.
Routine Care + Glycemic Excursion Minimization (RC+GEM)Behavioural
Also called Glucose Everyday Matters
In addition to receiving routine care, participants will receive GEM, a structured, self-directed, and personalized program that will allow participants with pre-diabetes to improve their metabolic status by illustrating the effects of their routine food and physical activity choices on their blood glucose levels and variability.
Routine Care (RC)Other
RC participants will meet with their primary care provider to determine the best diabetes medication and proper dose. The participant will be allowed to change medications, or use a combination of medications, that is best suited for their care during the duration of the study. The study team will not influence these decisions.
| Study group | Role | What they receive |
|---|---|---|
| Routine Care (RC) | Active comparator | Participants will be actively working with their primary care provider during the study and will attend appointments with their provider as needed. The study team will monitor their progress at the scheduled Assessment Visits. The participants should discuss any concerns they have, including side effects or cost, in order to adjust the medication regime with their primary care team. Their physician/clinician may recommend additional things, like weight loss, exercise programs and/or diabetes education programs. Receives: Other: Routine Care (RC) |
| Routine Care + Glucose Excursion Minimization (RC+GEM) | Experimental | Participants will actively work with their primary care provider and receive personalized routine care (RC). In addition, participants will receive GEM, an individualized, person-centered, empowerment program, not a behavior modification program. GEM provides individuals with personally relevant information to make choices that will help them achieve their diabetes goals. It focuses on techniques - eating low glycemic load foods, increasing moderate and vigorous exercise, and monitoring blood glucose (BG) to educate individuals about the impact of high glycemic load nutrients and vigorous exercise. The emphasis is on minimizing glucose excursions by any practical means, e.g., nutrient selection, timing and combinations of nutrient intake, time restricted eating, eating carbohydrates after protein and fat, post prandial physical activity, whatever is personally affirmed by BG feedback. Receives: Behavioral: Routine Care + Glycemic Excursion Minimization (RC+GEM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hemoglobin A1c at 4.5-months of follow-up
Repeated measures models, using the baseline Hemoglobin A1c, as a covariate, will be used to compare groups with respect to Hemoglobin A1c levels at the 4.5-month assessment.
Measured: 4.5 months
Change in Hemoglobin A1c at the 13.5-months of follow-up
Repeated measures models, using the baseline Hemoglobin A1c, as a covariate, will be used to compare groups with respect to Hemoglobin A1c levels at the 13.5-month assessment.
Measured: 13.5 months
Change in Metformin at 4.5-months of follow-up
Repeated measures models, using baseline Metformin, as a covariate, will be used to compare groups with respect to Metformin at the 4.5-month assessment.
Measured: 4.5 months
Change in Metformin at 13.5-months of follow-up
Repeated measures models, using baseline Metformin, as a covariate, will be used to compare groups with respect to Metformin at the 13.5-month assessment.
Measured: 13.5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2023
- Study start8 Aug 2023
- Primary completion31 May 2027 (estimated)
- Study completion31 May 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.
- 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
- Participants will be randomized to individualized routine care (RC) or to individualized RC in addition to post-nutrient glucose excursion minimization (RC+GEM). A Randomized Controlled Trial (RCT) design will be used to assign participants to treatment groups.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chiara Fabris, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), DexCom, Inc.
- Responsible party
- Sponsor-investigator, Chiara Fabris, PhD, University of Virginia
- Investigators
- Chiara Fabris, PhD, Principal investigator, University of Virginia Center for Diabetes TechnologyDaniel J. Cox, PhD, AHPP, Principal investigator, University of Virginia Center for Diabetes TechnologyTamara Oser, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05766735
- Sponsor's protocol ID
- 220259
- Other IDs
- R01DK129687
- Acronym
- GEM
- Status last verified
- May 2025
- First submitted
- 10 Feb 2023
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Will follow the NIH Data Sharing Policy and Implementation Guidance on sharing research resources for research purposes to qualified individuals in the scientific community.
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Early Type 2 Diabetes by Reducing Postprandial Glucose Excursions: A Paradigm Shift in Lifestyle Modification
- ClinicalTrials.gov ID
- NCT05766735
- Acronym / sponsor ID
- GEM / 220259
- Conditions
- Type 2 Diabetes
- Keywords
- Routine Care (RC), Routine Care + Glycemic Excursion Minimization (RC+GEM), Continuous Glucose Monitor (CGM), Randomized Controlled Trial (RCT), Blood Glucose (BG), Newly Diagnosed Type 2 Diabetes, Type 2 diabetes (T2D), Primary Care Provider (PCP)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Chiara Fabris, PhDUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), DexCom, Inc.
- Study start
- 8 Aug 2023 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 13 Mar 2023 (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.
A Randomized Control Trial (RCT) with 1:1 randomization of adults newly diagnosed with type 2 diabetes (T2D) to Routine Care (RC) and RC + Glycemic Excursion Minimization (RC+GEM); a program that provides RC in addition to continuous glucose monitors (CGM) within a structured, self-directed, and personalized lifestyle program called GEM. Our hypothesis is that RC+GEM will: 1) reduce hemoglobin A1c as much or more, 2) require less diabetes medication, 3) cost less, and 4) have more secondary benefits, (e.g. greater reduction in cardiovascular risk, weight, diabetes distress, depression symptoms), compared to RC alone.
Detailed description
The proposed study will compare individualized self-administered versions of RC+GEM to RC among patients recently diagnosed with type 2 diabetes. We hypothesize that, compared to RC alone, RC+GEM will be at least as effective at improving blood glucose control (A1c), and RC+GEM will do so with less reliance on diabetes medication and with greater secondary benefits such as lower risk of cardiovascular disease, more "good" cholesterol (HDL), greater weight loss, a greater sense of empowerment, and fewer diabetes-related expenses. It is further hypothesized that these benefits will be sustained over 13.5-months of follow-up with no structured maintenance program.
Remote study visits are permitted. Clinic visit and remote visits may include videoconferencing, phone, text messages and emails.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized to individualized routine care (RC) or to individualized RC in addition to post-nutrient glucose excursion minimization (RC+GEM). A Randomized Controlled Trial (RCT) design will be used to assign participants to treatment groups.
| Arm | Type | Receives |
|---|---|---|
| Routine Care (RC) | Active comparator | Other: Routine Care (RC)Participants will be actively working with their primary care provider during the study and will attend appointments with their provider as needed. The study team will monitor their progress at the scheduled Assessment Visits. The participants should discuss any concerns they have, including side effects or cost, in order to adjust the medication regime with their primary care team. Their physician/clinician may recommend additional things, like weight loss, exercise programs and/or diabetes education programs. |
| Routine Care + Glucose Excursion Minimization (RC+GEM) | Experimental | Behavioral: Routine Care + Glycemic Excursion Minimization (RC+GEM)Participants will actively work with their primary care provider and receive personalized routine care (RC). In addition, participants will receive GEM, an individualized, person-centered, empowerment program, not a behavior modification program. GEM provides individuals with personally relevant information to make choices that will help them achieve their diabetes goals. It focuses on techniques - eating low glycemic load foods, increasing moderate and vigorous exercise, and monitoring blood glucose (BG) to educate individuals about the impact of high glycemic load nutrients and vigorous exercise. The emphasis is on minimizing glucose excursions by any practical means, e.g., nutrient selection, timing and combinations of nutrient intake, time restricted eating, eating carbohydrates after protein and fat, post prandial physical activity, whatever is personally affirmed by BG feedback. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Clinical diagnosis, based on investigator assessment, of type 2 diabetes within the past 24 months
- Age ≥30.0 and ≤80 years
- Hemoglobin A1c = ≥6.5-≤11% (medical record value <6 month-old is acceptable)
- Access to smartphone throughout the study
- Diabetes management visit with medical provider within 12 months of screening date
Key exclusion criteria (12 listed)
- Medications that impede weight loss within the last 3 months, per study physicians' discretion
- Any psychotropic medication that could raise blood glucose, per study physicians' opinion
- Conditions that preclude participating in the study (e.g., severe mental disease like manic depressive illness, severe depression, active substance abuse)
- Conditions that preclude increasing physical activity (e.g., severe neuropathy, cardiovascular disease, COPD/emphysema, severe osteoarthritis, stroke)
- Conditions that prevent doing the self-directed GEM program, such as inability to read English, mental health conditions that prevent engagement in treatment, such as active substance abuse, severe depression
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 |
|---|---|---|
| Routine Care + Glycemic Excursion Minimization (RC+GEM)Also: Glucose Everyday MattersIn addition to receiving routine care, participants will receive GEM, a structured, self-directed, and personalized program that will allow participants with pre-diabetes to improve their metabolic status by illustrating the effects of their routine food and physical activity choices on their blood glucose levels and variability. | Behavioural | Routine Care + Glucose Excursion Minimization (RC+GEM) |
| Routine Care (RC)RC participants will meet with their primary care provider to determine the best diabetes medication and proper dose. The participant will be allowed to change medications, or use a combination of medications, that is best suited for their care during the duration of the study. The study team will not influence these decisions. | Other | Routine Care (RC) |
Primary outcome
Change in Hemoglobin A1c at 4.5-months of follow-up
Time frame: 4.5 months
Repeated measures models, using the baseline Hemoglobin A1c, as a covariate, will be used to compare groups with respect to Hemoglobin A1c levels at the 4.5-month assessment.
Change in Hemoglobin A1c at the 13.5-months of follow-up
Time frame: 13.5 months
Repeated measures models, using the baseline Hemoglobin A1c, as a covariate, will be used to compare groups with respect to Hemoglobin A1c levels at the 13.5-month assessment.
Change in Metformin at 4.5-months of follow-up
Time frame: 4.5 months
Repeated measures models, using baseline Metformin, as a covariate, will be used to compare groups with respect to Metformin at the 4.5-month assessment.
Change in Metformin at 13.5-months of follow-up
Time frame: 13.5 months
Repeated measures models, using baseline Metformin, as a covariate, will be used to compare groups with respect to Metformin at the 13.5-month assessment.
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 9 Apr 2026.
- Individual participant dataSharing planned: Yes. Will follow the NIH Data Sharing Policy and Implementation Guidance on sharing research resources for research purposes to qualified individuals in the scientific community.
Related trials for Type 2 Diabetes
Recruiting
Differentiating Heart Disease Between Adult-onset Autoimmune and Type 2 Diabetes
Diabete Mellitus, Autoimmune Diabetes
RecruitingObservational study
Study of High Density Lipoprotein Function in Type 1 Diabetic Patients With Nephropathy
Type 1 Diabetes
Active, not recruitingPhase 3
Clinical Application of Stem Cell Educator Therapy in Type 1 Diabetes
Type 1 Diabetes
Recruiting
Closed Loop and Education for Hypoglycemia Awareness Restoration
Diabetes Mellitus, Type 1
Not yet recruiting
Peer Support and Remote Patient Monitoring for Black Adults With Type 2 Diabetes
Type 2 Diabetes
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.
Chiara Fabris, PhD principal investigator
University of Virginia Center for Diabetes Technology
Daniel J. Cox, PhD, AHPP principal investigator
University of Virginia Center for Diabetes Technology
Tamara Oser, MD principal investigator
University of Colorado, Denver
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Routine Care + Glycemic Excursion Minimization (RC+GEM) and Routine Care (RC) in people with Type 2 Diabetes, run by Chiara Fabris, PhD at 2 sites 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 6 inclusion and 12 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 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Jacqueline Rodriguez (434-422-2653, ZMT8XG@uvahealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hemoglobin A1c at 4.5-months of follow-up (time frame: 4.5 months). The study lists 4 primary outcomes in all. 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 9 Apr 2026; AzTrials last refreshed its copy on 2 Nov 2026.