Type 2 DiabetesCMGProjectNCT05351190
Community Glucose Monitoring Project
A study testing Dexcom G6 CGM in people with Type 2 Diabetes, run by Blanchard Valley Health System at 1 site in United States.
Trial summary
The investigators believe that addition of real time continuous glucose monitoring (RT-CGM) improves glycemic outcome in patients with Type 2 diabetes compared to self-monitored blood glucose (SMBG), for patients who are not at target A1C regardless of treatment modality. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Dexcom G6 CGM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2022to 31 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Diagnosis of T2DM
- Followed regularly by a physician with at least 2 office visits in last year as documented by clinical history
- Sub-optimal glycemic control, defined as persistent hyperglycemia, confirmed initially by historical or local (POC or site's lab) A1C of ≥7.7% NOTE: Use of a historical local A1C test must be within 1 month of study entry.
- Desire to lower A1C such as a goal of 7%
- Stable control of diabetes, as determined per investigator assessment
- Willing to wear a CGM
Who cannot join
- Use of personal RT-CGM 3 months prior to study entry (professional CGM use is allowed, whether it was blinded or un-blinded)
- Current or anticipated acute uses of glucocorticoids (oral, injectable, or IV), that will affect glycemic control and impact A1C - such as frequent steroid bursts required for inflammatory arthritis or inflammatory bowel disease, recurrent lumbar epidural steroid injections, etc. (Long-term stable glucocorticoid doses are allowed, such as when used for the treatment of rheumatoid arthritis or Addison's disease).
- Pregnancy (as demonstrated by a positive test at study entry screening) or are planning to become pregnant during the study
- Medical conditions that, per investigator determination, make it inappropriate or unsafe to target an A1C of <7%, such as, but not limited to, recent cardio- or cerebro- vascular disease, malignancy, severe recurrent hypoglycemia, or cognitive decline
- History of visual impairment which would hinder subject's participation in the study and perform all study procedures safely, as determined by investigator
- History of psychiatric, psychological disorder, or psycho-social issues that could limit adherence to the required study tasks
Show all 12Show fewer
- Renal disease defined as estimated Glomerular Filtration Rate (eGFR) <45)
- Extensive skin changes/disease that preclude wearing the sensor on normal skin (e.g. extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis)
- Known allergy to medical-grade adhesives
- Current participation in another investigational study (must have completed any previous studies at least 30 days prior to being enrolled in this study)
- Currently abusing illicit drugs, alcohol, or prescription drugs
- Any condition per investigator assessment, that could impact reliability of the A1C measurement, such as (but not limited to) hemoglobinopathy, hemolytic anemia, chronic liver disease; chronic GI blood loss, recent red blood cell transfusion or erythropoietin administration within 3 months prior to screening
Trial locations and contacts
1 site in 1 country.
United States1 site
Hancock County Health Department
Findlay, Ohio, 45840
About this study
Official title: Community Glucose Monitoring (CGM) Project
The investigators believe that addition of real time continuous glucose monitoring (RT-CGM) improves glycemic outcome in patients with Type 2 diabetes compared to self-monitored blood glucose (SMBG), for patients who are not at target A1C regardless of treatment modality.
The investigators aims to assess glycemic and quality of life (QoL) benefits of adding and using RT-CGM patients with Type 2 Diabetes Mellitus (T2DM), not at their A1C goal and relying on SMBG for diabetes-management decisions.
Read the detailed description
Prescreened and eligible subjects will obtain CGM and basic CGM education upon enrollment.
They will initially be given three months of CGM supplies and return to the study center every 3 months for more supplies. In addition, baseline data and labs will be collected at visits.
All subjects will return to the clinic after every three months for assessment and assignment of three more months of CGM supplies. This will repeat for a 12 month period.
Patient reported outcome (PRO) measurements will be obtained at the beginning and end of the study.
- Conditions
- Type 2 Diabetes
- Being tested
- Dexcom G6 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.
Dexcom G6 CGMDevice
rtCGM to be worn by user continuously for the duration of the 12 month study
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Other | All participants will be given a rtCGM (Dexcom G6) to assess their glycemic control. Receives: Device: Dexcom G6 CGM |
What is being measured
The primary outcome is the main question the study is designed to answer.
A1c
Record Changes in HgbA1c
Measured: Baseline to 3 months
A1c
Record Changes in HgbA1c
Measured: Baseline to 6 months
A1c
Record Changes in HgbA1c
Measured: Baseline to 9 months
A1c
Record Changes in HgbA1c
Measured: Baseline to 12 months
Secondary outcomes (22)
Weight
Record Changes
Measured: Baseline to 3 months
Weight
Record Changes
Measured: Baseline to 6 months
Weight
Record Changes
Measured: Baseline to 9 months
Weight
Record Changes
Measured: Baseline to 12 months
BMI
Record Changes
Measured: Baseline to 3 months
BMI
Record Changes
Measured: Baseline to 6 months
BMI
Record Changes
Measured: Baseline to 9 months
BMI
Record Changes
Measured: Baseline to 12 months
Percent Time in Range (70-180 mg/dl)
Record Changes
Measured: Baseline to 3 months
Percent Time in Range (70-180 mg/dl)
Record Changes
Measured: Baseline to 6 months
Percent Time in Range (70-180 mg/dl)
Record Changes
Measured: Baseline to 9 months
Percent Time in Range (70-180 mg/dl)
Record Changes
Measured: Baseline to 12 months
Percent Time in Hypoglycemia (<70 mg/dl)
Record Changes
Measured: Baseline to 3 months
Percent Time in Hypoglycemia (<70 mg/dl)
Record Changes
Measured: Baseline to 6 months
Percent Time in Hypoglycemia (<70 mg/dl)
Record Changes
Measured: Baseline to 9 months
Percent Time in Hypoglycemia (<70 mg/dl)
Record Changes
Measured: Baseline to 12 months
Percent Time in Hyperglycemia (>180 mg/dl)
Record Changes
Measured: Baseline to 3 months
Percent Time in Hyperglycemia (>180 mg/dl)
Record Changes
Measured: Baseline to 6 months
Percent Time in Hyperglycemia (>180 mg/dl)
Record Changes
Measured: Baseline to 9 months
Percent Time in Hyperglycemia (>180 mg/dl)
Record Changes
Measured: Baseline to 12 months
Quality of Life - GMSS T2DM Version
Record Changes in QoL
Measured: Baseline to 6 months
Quality of Life - GMSS T2DM Version
Record Changes in QoL
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start15 May 2022
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Dec 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Blanchard Valley Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Grace, MD, Blanchard Valley Health System
- Investigators
- Thomas Grace, MD, Principal investigator, Hancock County Health Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05351190
- Sponsor's protocol ID
- IIS-2021-169
- Acronym
- CMGProject
- Status last verified
- Mar 2023
- First submitted
- 18 Apr 2022
- Last updated
- 9 Mar 2023
- 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 9 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Glucose Monitoring (CGM) Project
- ClinicalTrials.gov ID
- NCT05351190
- Acronym / sponsor ID
- CMGProject / IIS-2021-169
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Blanchard Valley Health SystemUniversity, hospital or other
- Study start
- 15 May 2022 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 28 Apr 2022 (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 investigators believe that addition of real time continuous glucose monitoring (RT-CGM) improves glycemic outcome in patients with Type 2 diabetes compared to self-monitored blood glucose (SMBG), for patients who are not at target A1C regardless of treatment modality.
The investigators aims to assess glycemic and quality of life (QoL) benefits of adding and using RT-CGM patients with Type 2 Diabetes Mellitus (T2DM), not at their A1C goal and relying on SMBG for diabetes-management decisions.
Detailed description
Prescreened and eligible subjects will obtain CGM and basic CGM education upon enrollment.
They will initially be given three months of CGM supplies and return to the study center every 3 months for more supplies. In addition, baseline data and labs will be collected at visits.
All subjects will return to the clinic after every three months for assessment and assignment of three more months of CGM supplies. This will repeat for a 12 month period.
Patient reported outcome (PRO) measurements will be obtained at the beginning and end of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Other | Device: Dexcom G6 CGMAll participants will be given a rtCGM (Dexcom G6) to assess their glycemic control. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 years or older
- Diagnosis of T2DM
- Followed regularly by a physician with at least 2 office visits in last year as documented by clinical history
- Sub-optimal glycemic control, defined as persistent hyperglycemia, confirmed initially by historical or local (POC or site's lab) A1C of ≥7.7% NOTE: Use of a historical local A1C test must be within 1 month of study entry.
- Desire to lower A1C such as a goal of 7%
Key exclusion criteria (12 listed)
- Use of personal RT-CGM 3 months prior to study entry (professional CGM use is allowed, whether it was blinded or un-blinded)
- Current or anticipated acute uses of glucocorticoids (oral, injectable, or IV), that will affect glycemic control and impact A1C - such as frequent steroid bursts required for inflammatory arthritis or inflammatory bowel disease, recurrent lumbar epidural steroid injections, etc. (Long-term stable glucocorticoid doses are allowed, such as when used for the treatment of rheumatoid arthritis or Addison's disease).
- Pregnancy (as demonstrated by a positive test at study entry screening) or are planning to become pregnant during the study
- Medical conditions that, per investigator determination, make it inappropriate or unsafe to target an A1C of <7%, such as, but not limited to, recent cardio- or cerebro- vascular disease, malignancy, severe recurrent hypoglycemia, or cognitive decline
- History of visual impairment which would hinder subject's participation in the study and perform all study procedures safely, as determined by investigator
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 |
|---|---|---|
| Dexcom G6 CGMrtCGM to be worn by user continuously for the duration of the 12 month study | Device | Treatment Arm |
Primary outcome
A1c
Time frame: Baseline to 3 months
Record Changes in HgbA1c
A1c
Time frame: Baseline to 6 months
Record Changes in HgbA1c
A1c
Time frame: Baseline to 9 months
Record Changes in HgbA1c
A1c
Time frame: Baseline to 12 months
Record Changes in HgbA1c
22 secondary outcomes
Weight
Time frame: Baseline to 3 months
Weight
Time frame: Baseline to 6 months
Weight
Time frame: Baseline to 9 months
Weight
Time frame: Baseline to 12 months
BMI
Time frame: Baseline to 3 months
BMI
Time frame: Baseline to 6 months
BMI
Time frame: Baseline to 9 months
BMI
Time frame: Baseline to 12 months
Percent Time in Range (70-180 mg/dl)
Time frame: Baseline to 3 months
Percent Time in Range (70-180 mg/dl)
Time frame: Baseline to 6 months
Percent Time in Range (70-180 mg/dl)
Time frame: Baseline to 9 months
Percent Time in Range (70-180 mg/dl)
Time frame: Baseline to 12 months
Percent Time in Hypoglycemia (<70 mg/dl)
Time frame: Baseline to 3 months
Percent Time in Hypoglycemia (<70 mg/dl)
Time frame: Baseline to 6 months
Percent Time in Hypoglycemia (<70 mg/dl)
Time frame: Baseline to 9 months
Percent Time in Hypoglycemia (<70 mg/dl)
Time frame: Baseline to 12 months
Percent Time in Hyperglycemia (>180 mg/dl)
Time frame: Baseline to 3 months
Percent Time in Hyperglycemia (>180 mg/dl)
Time frame: Baseline to 6 months
Percent Time in Hyperglycemia (>180 mg/dl)
Time frame: Baseline to 9 months
Percent Time in Hyperglycemia (>180 mg/dl)
Time frame: Baseline to 12 months
Quality of Life - GMSS T2DM Version
Time frame: Baseline to 6 months
Quality of Life - GMSS T2DM Version
Time frame: Baseline to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2023.
- 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. This study is not recruiting at the moment.
Thomas Grace, MD principal investigator
Hancock County Health Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexcom G6 CGM in people with Type 2 Diabetes, run by Blanchard Valley Health System 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 7 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: status not confirmed, as of the sponsor's last update on 9 Mar 2023. 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?
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?
A1c (time frame: Baseline to 3 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 Mar 2023; AzTrials last refreshed its copy on 7 Nov 2026.