CClinicalTrials.gg
Status unknownNCT05351190CMGProjectUpdated Mar 9, 2023

Community Glucose Monitoring Project

An interventional study of Dexcom G6 CGM in Type 2 Diabetes, sponsored by Blanchard Valley Health System. Status unknown at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-09.

Sponsored by Blanchard Valley Health System · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2023), so the status shown — last known as Enrolling by invitation — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Type 2 Diabetes
03

In context

Lead sponsor

This is the only study on the registry with Blanchard Valley Health System as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Age 18 years or older
  2. Diagnosis of T2DM
  3. Followed regularly by a physician with at least 2 office visits in last year as documented by clinical history
  4. 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.
  5. Desire to lower A1C such as a goal of 7%
  6. Stable control of diabetes, as determined per investigator assessment
  7. Willing to wear a CGM

Exclusion criteria

Exclusion Criteria:

  1. Use of personal RT-CGM 3 months prior to study entry (professional CGM use is allowed, whether it was blinded or un-blinded)
  2. 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).
  3. Pregnancy (as demonstrated by a positive test at study entry screening) or are planning to become pregnant during the study
  4. 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
  5. History of visual impairment which would hinder subject's participation in the study and perform all study procedures safely, as determined by investigator
  6. History of psychiatric, psychological disorder, or psycho-social issues that could limit adherence to the required study tasks
  7. Renal disease defined as estimated Glomerular Filtration Rate (eGFR) \<45)
  8. 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)
  9. Known allergy to medical-grade adhesives
  10. Current participation in another investigational study (must have completed any previous studies at least 30 days prior to being enrolled in this study)
  11. Currently abusing illicit drugs, alcohol, or prescription drugs
  12. 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Other
    Treatment Arm

    All participants will be given a rtCGM (Dexcom G6) to assess their glycemic control.

    Device: Dexcom G6 CGM

Interventions

  • DeviceDexcom G6 CGM

    rtCGM to be worn by user continuously for the duration of the 12 month study

06

What researchers measure

Primary outcomes

  1. A1c

    Record Changes in HgbA1c

    Time frame: Baseline to 3 months

  2. A1c

    Record Changes in HgbA1c

    Time frame: Baseline to 6 months

  3. A1c

    Record Changes in HgbA1c

    Time frame: Baseline to 9 months

  4. A1c

    Record Changes in HgbA1c

    Time frame: Baseline to 12 months

Secondary outcomes

  1. Weight

    Record Changes

    Time frame: Baseline to 3 months

  2. Weight

    Record Changes

    Time frame: Baseline to 6 months

  3. Weight

    Record Changes

    Time frame: Baseline to 9 months

  4. Weight

    Record Changes

    Time frame: Baseline to 12 months

  5. BMI

    Record Changes

    Time frame: Baseline to 3 months

  6. BMI

    Record Changes

    Time frame: Baseline to 6 months

  7. BMI

    Record Changes

    Time frame: Baseline to 9 months

  8. BMI

    Record Changes

    Time frame: Baseline to 12 months

  9. Percent Time in Range (70-180 mg/dl)

    Record Changes

    Time frame: Baseline to 3 months

  10. Percent Time in Range (70-180 mg/dl)

    Record Changes

    Time frame: Baseline to 6 months

  11. Percent Time in Range (70-180 mg/dl)

    Record Changes

    Time frame: Baseline to 9 months

  12. Percent Time in Range (70-180 mg/dl)

    Record Changes

    Time frame: Baseline to 12 months

  13. Percent Time in Hypoglycemia (<70 mg/dl)

    Record Changes

    Time frame: Baseline to 3 months

  14. Percent Time in Hypoglycemia (<70 mg/dl)

    Record Changes

    Time frame: Baseline to 6 months

  15. Percent Time in Hypoglycemia (<70 mg/dl)

    Record Changes

    Time frame: Baseline to 9 months

  16. Percent Time in Hypoglycemia (<70 mg/dl)

    Record Changes

    Time frame: Baseline to 12 months

  17. Percent Time in Hyperglycemia (>180 mg/dl)

    Record Changes

    Time frame: Baseline to 3 months

  18. Percent Time in Hyperglycemia (>180 mg/dl)

    Record Changes

    Time frame: Baseline to 6 months

  19. Percent Time in Hyperglycemia (>180 mg/dl)

    Record Changes

    Time frame: Baseline to 9 months

  20. Percent Time in Hyperglycemia (>180 mg/dl)

    Record Changes

    Time frame: Baseline to 12 months

  21. Quality of Life - GMSS T2DM Version

    Record Changes in QoL

    Time frame: Baseline to 6 months

  22. Quality of Life - GMSS T2DM Version

    Record Changes in QoL

    Time frame: Baseline to 12 months

07

Study locations

1 site
  • Hancock County Health Department
    Findlay, Ohio 45840, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 9, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05351190
Lead sponsor
Blanchard Valley Health System
Responsible party
Thomas Grace, MD (Principal Investigator, Blanchard Valley Health System) — Principal investigator
First posted
Apr 28, 2022
Start date
May 15, 2022
Primary completion
Aug 31, 2024 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Mar 9, 2023

Study contacts

Thomas Grace, MD
principal investigator · Hancock County Health Department

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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