Community Glucose Monitoring Project (CMGProject)

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Device: Dexcom G6 CGM

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 Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Findlay, Ohio, United States, 45840
      • Hancock County Health Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Treatment Arm; All participants will be given a rtCGM (Dexcom G6) to assess their glycemic control.	Device: Dexcom G6 CGM; rtCGM to be worn by user continuously for the duration of the 12 month study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
A1c	Record Changes in HgbA1c	Baseline to 3 months
A1c	Record Changes in HgbA1c	Baseline to 6 months
A1c	Record Changes in HgbA1c	Baseline to 9 months
A1c	Record Changes in HgbA1c	Baseline to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight	Record Changes	Baseline to 3 months
Weight	Record Changes	Baseline to 6 months
Weight	Record Changes	Baseline to 9 months
Weight	Record Changes	Baseline to 12 months
BMI	Record Changes	Baseline to 3 months
BMI	Record Changes	Baseline to 6 months
BMI	Record Changes	Baseline to 9 months
BMI	Record Changes	Baseline to 12 months
Quality of Life - GMSS T2DM Version	Record Changes in QoL	Baseline to 6 months
Quality of Life - GMSS T2DM Version	Record Changes in QoL	Baseline to 12 months
Percent Time in Range (70-180 mg/dl)	Record Changes	Baseline to 3 months
Percent Time in Range (70-180 mg/dl)	Record Changes	Baseline to 6 months
Percent Time in Range (70-180 mg/dl)	Record Changes	Baseline to 9 months
Percent Time in Range (70-180 mg/dl)	Record Changes	Baseline to 12 months
Percent Time in Hypoglycemia (<70 mg/dl)	Record Changes	Baseline to 3 months
Percent Time in Hypoglycemia (<70 mg/dl)	Record Changes	Baseline to 6 months
Percent Time in Hypoglycemia (<70 mg/dl)	Record Changes	Baseline to 9 months
Percent Time in Hypoglycemia (<70 mg/dl)	Record Changes	Baseline to 12 months
Percent Time in Hyperglycemia (>180 mg/dl)	Record Changes	Baseline to 3 months
Percent Time in Hyperglycemia (>180 mg/dl)	Record Changes	Baseline to 6 months
Percent Time in Hyperglycemia (>180 mg/dl)	Record Changes	Baseline to 9 months
Percent Time in Hyperglycemia (>180 mg/dl)	Record Changes	Baseline to 12 months

Collaborators and Investigators

• Sponsor: Blanchard Valley Health System
• Investigators: Principal Investigator: Thomas Grace, MD, Hancock County Health Department

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2022
• Primary Completion (Anticipated): August 31, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: April 18, 2022
• First Submitted That Met QC Criteria: April 22, 2022
• First Posted (Actual): April 28, 2022

Study Record Updates

• Last Update Posted (Estimate): March 9, 2023
• Last Update Submitted That Met QC Criteria: March 7, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: IIS-2021-169

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes