DiabetesCGM-DWINCT07128342
CGM Use in Non-insulin Patients With DM2
A study testing CGM Group and FSBG group in people with Diabetes and Type 2 Diabetes (T2DM), run by Milwaukee VA Medical Center.
Trial summary
The U.S. Food and Drug Administration (FDA) has approved multiple Continuous Glucose Monitoring (CGM) devices from different manufacturers to be used as an aide in patients with type 1 and type 2 diabetes who require medications, and more recently, as over the counter versions for patients with and or without diabetes… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Type 2 Diabetes (T2DM), Obesity Type 2 Diabetes Mellitus
- What is being tested?
- CGM Group and FSBG group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2025to Nov 2028
- 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
- Successfully enrolled and ready to begin the VDOP program not on insulin therapy
- Type 2 diabetes by clinical history
- HbA1C between 8.0-12.0% inclusive within 3 months of enrollment
- Assessment by clinician that patient is willing to and able to wear a CGM device
- Stable diabetes medication regimen during the 3 months prior to entry
Who cannot join
- Patients already or planned on starting insulin therapy, already on CGM, or those who qualify for CGM under VA policy
- Patients with gestational diabetes or pregnant at time of screening or are planning to become pregnant during the study
- Patients with end stage renal disease (ESRD) on dialysis
- Anticipated acute uses of glucocorticoids (oral, injectable, or IV)
- Acute conditions that impact the HbA1c measurement stability such as GI blood loss, recent (within 3 months of study entry), anticipated red blood cell transfusion or erythropoietin administration
- Known or suspected significant allergy to use the Dexcom sensors
- Planning or currently enrolled on different weight program different from MOVE!
- Participating other clinical trials
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Colleen Veenendaal, RN, Research Coordinator contact
About this study
Official title: Use of Continuous Glucose Monitoring in Veterans With Uncontrolled Diabetes Managed Without Insulin Therapy
The U.S. Food and Drug Administration (FDA) has approved multiple Continuous Glucose Monitoring (CGM) devices from different manufacturers to be used as an aide in patients with type 1 and type 2 diabetes who require medications, and more recently, as over the counter versions for patients with and or without diabetes who want to better understand how diet and exercise may impact blood sugar levels. However robust evidence supporting that CGM is significantly superior to traditional home fingerstick blood glucose monitoring (FSBGM) in this population is lacking. Thus, Medicare and VHA only authorize use of CGM for patients with diabetes who require daily insulin therapy , unless they meet special criteria such as having hypoglycemia or inability to monitor glucose via traditional FSBGM.
Objectives Primary Study Aim: Among veterans with uncontrolled diabetes not requiring insulin therapy who are participating in an intensive multidisciplinary program to improve diabetes control (VDOP), to assess whether use of a CGM compared to use of traditional FSBGM results in greater change in hemoglobin A1c upon VDOP completion and up to 12 months.
Read more
Secondary study aims: To assess whether use of CGM in this population leads to greater improvement in diet, physical activity, and weight loss upon VDOP completion and up to 12 months.
Hypothesis
The use of a CGM by Veterans with T2DM who do not use insulin will help them improve their diabetes self - management (diet, physical activity, weight) and glycemic control more so than those using traditional fingerstick glucose monitoring.
Methods
This will be a prospective "open label" randomized controlled trial where participants will be randomly assigned to CGM (intervention group) or FSBGM (control group) during their participation in VDOP.
Relevance to Veterans and VA mission
Most Veterans with T2DM do not use insulin. It is important for both, these Veterans and the VA, to learn whether this more costly and somewhat burdensome technology supports improvement in diabetes self-management
- Conditions
- Diabetes, Type 2 Diabetes (T2DM), Obesity Type 2 Diabetes Mellitus, Non Insulin Dependent Diabetes Mellitus
- Being tested
- CGM Group, FSBG group
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CGM GroupDevice
This group of patients will receive a CGM device to monitor their blood glucoses
FSBG groupDevice
This group of patients will receive a fingerstick blood glucose (FSBG) device for glucose monitoring
| Study group | Role | What they receive |
|---|---|---|
| CGM group | Active comparator | This group will receive CGM device for glucose monitoring Receives: Device: CGM Group |
| FSBG group | Active comparator | This group will receive fingerstick device for glucose monitoring Receives: Device: FSBG group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic Control
HbA1c
Measured: 12 months
Secondary outcomes (1)
Weight loss
lbs, Kg, and BMI
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2025
- Study start1 Nov 2025 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Milwaukee VA Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Carlos Mendez, Milwaukee VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07128342
- Sponsor's protocol ID
- 1856488
- Acronym
- CGM-DWI
- Status last verified
- Aug 2025
- First submitted
- 12 Aug 2025
- Last updated
- 18 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Continuous Glucose Monitoring in Veterans With Uncontrolled Diabetes Managed Without Insulin Therapy
- ClinicalTrials.gov ID
- NCT07128342
- Acronym / sponsor ID
- CGM-DWI / 1856488
- Conditions
- Diabetes, Type 2 Diabetes (T2DM), Obesity Type 2 Diabetes Mellitus, Non Insulin Dependent Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Milwaukee VA Medical CenterUS federal agency
- Study start
- 1 Nov 2025 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 18 Aug 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.
The U.S. Food and Drug Administration (FDA) has approved multiple Continuous Glucose Monitoring (CGM) devices from different manufacturers to be used as an aide in patients with type 1 and type 2 diabetes who require medications, and more recently, as over the counter versions for patients with and or without diabetes who want to better understand how diet and exercise may impact blood sugar levels. However robust evidence supporting that CGM is significantly superior to traditional home fingerstick blood glucose monitoring (FSBGM) in this population is lacking. Thus, Medicare and VHA only authorize use of CGM for patients with diabetes who require daily insulin therapy , unless they meet special criteria such as having hypoglycemia or inability to monitor glucose via traditional FSBGM.
Objectives Primary Study Aim: Among veterans with uncontrolled diabetes not requiring insulin therapy who are participating in an intensive multidisciplinary program to improve diabetes control (VDOP), to assess whether use of a CGM compared to use of traditional FSBGM results in greater change in hemoglobin A1c upon VDOP completion and up to 12 months.
Secondary study aims: To assess whether use of CGM in this population leads to greater improvement in diet, physical activity, and weight loss upon VDOP completion and up to 12 months.
Hypothesis
The use of a CGM by Veterans with T2DM who do not use insulin will help them improve their diabetes self - management (diet, physical activity, weight) and glycemic control more so than those using traditional fingerstick glucose monitoring.
Methods
This will be a prospective "open label" randomized controlled trial where participants will be randomly assigned to CGM (intervention group) or FSBGM (control group) during their participation in VDOP.
Relevance to Veterans and VA mission
Most Veterans with T2DM do not use insulin. It is important for both, these Veterans and the VA, to learn whether this more costly and somewhat burdensome technology supports improvement in diabetes self-management
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CGM group | Active comparator | Device: CGM GroupThis group will receive CGM device for glucose monitoring |
| FSBG group | Active comparator | Device: FSBG groupThis group will receive fingerstick device for glucose monitoring |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Successfully enrolled and ready to begin the VDOP program not on insulin therapy
- Type 2 diabetes by clinical history
- HbA1C between 8.0-12.0% inclusive within 3 months of enrollment
- Assessment by clinician that patient is willing to and able to wear a CGM device
- Stable diabetes medication regimen during the 3 months prior to entry
Key exclusion criteria (8 listed)
- Patients already or planned on starting insulin therapy, already on CGM, or those who qualify for CGM under VA policy
- Patients with gestational diabetes or pregnant at time of screening or are planning to become pregnant during the study
- Patients with end stage renal disease (ESRD) on dialysis
- Anticipated acute uses of glucocorticoids (oral, injectable, or IV)
- Acute conditions that impact the HbA1c measurement stability such as GI blood loss, recent (within 3 months of study entry), anticipated red blood cell transfusion or erythropoietin administration
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 |
|---|---|---|
| CGM GroupThis group of patients will receive a CGM device to monitor their blood glucoses | Device | CGM group |
| FSBG groupThis group of patients will receive a fingerstick blood glucose (FSBG) device for glucose monitoring | Device | FSBG group |
Primary outcome
Glycemic Control
Time frame: 12 months
HbA1c
1 secondary outcome
Weight loss
Time frame: 12 months
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 18 Aug 2025.
- Individual participant dataSharing planned: No
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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.
Colleen Veenendaal, RN, Research Coordinator contact
Questions about this trial
What is this clinical trial studying?
A study testing CGM Group and FSBG group in people with Diabetes and Type 2 Diabetes (T2DM), run by Milwaukee VA Medical Center.
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 5 inclusion and 8 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: opening soon, as of the sponsor's last update on 18 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Carlos E Mendez, MD (414-384-2000 ext. 41435, carlos.mendez2@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic Control (time frame: 12 months). 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 18 Aug 2025; AzTrials last refreshed its copy on 6 Nov 2026.