Type 2 DiabetesGEMNCT06236581
Glycemic Excursion Minimization (GEM) to Outshine Health Disparities
A study testing GEM Intervention in people with Type 2 Diabetes, run by Catherine Davis at 1 site in United States.
Trial summary
The purpose of this study is to see if the GEM intervention is acceptable and helpful to Black adults with type 2 diabetes. The GEM intervention (coaching to reduce carbohydrate intake and increase physical activity after meals, with feedback from a continuous glucose monitor, CGM) might improve blood glucose levels… 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?
- GEM Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jun 2024to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- type 2 diabetes
- capable of making dietary and physical activity changes
Who cannot join
- on insulin or secretagogue
- on medications that impede weight loss (e.g., prednisone)
- pregnant or planning pregnancy in the next 2 months
- no history of moderate to severe hypoglycemia
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Georgia Prevention Institute
Augusta, Georgia, 30912
Andre Soares, PT MS, 706-721-4534
Catherine L Davis, PhD
About this study
Official title: Glycemic Excursion Minimization (GEM) to Outshine Health Disparities: RCT
The purpose of this study is to see if the GEM intervention is acceptable and helpful to Black adults with type 2 diabetes. The GEM intervention (coaching to reduce carbohydrate intake and increase physical activity after meals, with feedback from a continuous glucose monitor, CGM) might improve blood glucose levels, reduce diabetes distress, and increase empowerment and confidence in managing diabetes.
Read the detailed description
The purpose of the study is to test the feasibility, acceptability, and initial efficacy of the tailored GEM intervention among adult Black patients with type 2 diabetes, who are not on insulin or secretagogues.
- Conditions
- Type 2 Diabetes
- Being tested
- GEM Intervention
- Keywords
- Black, Continuous glucose monitoring, physical activity, carbohydrate
- Medical subject headings
- Diabetes Mellitus, Type 2, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GEM InterventionBehavioural
Lifestyle coaching
| Study group | Role | What they receive |
|---|---|---|
| GEM Intervention | Experimental | A lifestyle coach will deliver the GEM intervention over 4 weeks in person and/or virtually (synchronously) to permit interaction with participants. A pocket-sized manual will be provided with 4 units corresponding to session topics, and diary pages to record glucose responses to food and physical activity (PA). Session 1: Introduce GEM, identify personal motivation, learn about foods that cause glucose to go high (high glycemic load (GL) foods) and those that do not (low GL foods), learn how physical activity affects glucose, and begin monitoring how these choices affect glucose. Session 2: Replacement, substitution, and portion control to reduce consumption of high GL foods. Session 3: Increasing PA and reducing sedentary behavior, esp. after a meal. Session 4: Ways to continue lifestyle changes over a lifetime, handle relapses, and thank loved ones for their support. Text message reminders may be sent to participants between sessions to prompt diary entries and for encouragement. Receives: Behavioral: GEM Intervention |
| Waitlist | No intervention | Participants will be invited to receive the GEM intervention after they posttest, the next time it is offered. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline on percent time in range from continuous glucose monitor at post-intervention
Difference in percent of time in range (70-180 mg/dL) from continuous glucose monitor data. Change = post intervention week minus baseline week.
Measured: Baseline week and post-intervention week. From baseline week to the week after end of intervention or waitlist period, up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start20 Jun 2024
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial, intervention vs. waitlist
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Catherine Davis
- Sponsor type
- University, hospital or other
- Collaborators
- University of Virginia, University of Colorado, Denver
- Responsible party
- Sponsor-investigator, Catherine Davis, Augusta University
- Investigators
- Catherine L Davis, PhD, Principal investigator, Augusta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06236581
- Sponsor's protocol ID
- 1974851
- Acronym
- GEM
- Status last verified
- Jul 2024
- First submitted
- 24 Jan 2024
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The small number of expected participants means there is too great a risk of loss of confidentiality. Group level data will be shared upon request to qualified researchers.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glycemic Excursion Minimization (GEM) to Outshine Health Disparities: RCT
- ClinicalTrials.gov ID
- NCT06236581
- Acronym / sponsor ID
- GEM / 1974851
- Conditions
- Type 2 Diabetes
- Keywords
- Black, Continuous glucose monitoring, physical activity, carbohydrate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Catherine DavisUniversity, hospital or other
- Collaborators
- University of Virginia, University of Colorado, Denver
- Study start
- 20 Jun 2024 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 1 Feb 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.
The purpose of this study is to see if the GEM intervention is acceptable and helpful to Black adults with type 2 diabetes. The GEM intervention (coaching to reduce carbohydrate intake and increase physical activity after meals, with feedback from a continuous glucose monitor, CGM) might improve blood glucose levels, reduce diabetes distress, and increase empowerment and confidence in managing diabetes.
Detailed description
The purpose of the study is to test the feasibility, acceptability, and initial efficacy of the tailored GEM intervention among adult Black patients with type 2 diabetes, who are not on insulin or secretagogues.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial, intervention vs. waitlist
| Arm | Type | Receives |
|---|---|---|
| GEM Intervention | Experimental | Behavioral: GEM InterventionA lifestyle coach will deliver the GEM intervention over 4 weeks in person and/or virtually (synchronously) to permit interaction with participants. A pocket-sized manual will be provided with 4 units corresponding to session topics, and diary pages to record glucose responses to food and physical activity (PA). Session 1: Introduce GEM, identify personal motivation, learn about foods that cause glucose to go high (high glycemic load (GL) foods) and those that do not (low GL foods), learn how physical activity affects glucose, and begin monitoring how these choices affect glucose. Session 2: Replacement, substitution, and portion control to reduce consumption of high GL foods. Session 3: Increasing PA and reducing sedentary behavior, esp. after a meal. Session 4: Ways to continue lifestyle changes over a lifetime, handle relapses, and thank loved ones for their support. Text message reminders may be sent to participants between sessions to prompt diary entries and for encouragement. |
| Waitlist | No intervention | –Participants will be invited to receive the GEM intervention after they posttest, the next time it is offered. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- type 2 diabetes
- capable of making dietary and physical activity changes
Key exclusion criteria (4 listed)
- on insulin or secretagogue
- on medications that impede weight loss (e.g., prednisone)
- pregnant or planning pregnancy in the next 2 months
- no history of moderate to severe hypoglycemia
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 |
|---|---|---|
| GEM InterventionLifestyle coaching | Behavioural | GEM Intervention |
Primary outcome
Change from baseline on percent time in range from continuous glucose monitor at post-intervention
Time frame: Baseline week and post-intervention week. From baseline week to the week after end of intervention or waitlist period, up to 6 weeks
Difference in percent of time in range (70-180 mg/dL) from continuous glucose monitor data. Change = post intervention week minus baseline week.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Individual participant dataSharing planned: No. The small number of expected participants means there is too great a risk of loss of confidentiality. Group level data will be shared upon request to qualified researchers.
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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.
Catherine L Davis, PhD principal investigator
Augusta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GEM Intervention in people with Type 2 Diabetes, run by Catherine Davis 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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 30 Jul 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Catherine L Davis, PhD (706-721-4534, katie.davis@augusta.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline on percent time in range from continuous glucose monitor at post-intervention (time frame: Baseline week and post-intervention week. From baseline week to the week after end of intervention or waitlist period, up to 6 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 30 Jul 2024.