Community Glucose Monitoring Project

Type 2 Diabetes Clinical Trial

— CMGProject  

Official title:

Community Glucose Monitoring (CGM) Project

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05351190
• Other study ID #: IIS-2021-169
• Status: Enrolling by invitation
• Phase: N/A
• Start date: May 15, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2023
• Source: Blanchard Valley Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: December 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

Device:
• Dexcom G6 CGM
rtCGM to be worn by user continuously for the duration of the 12 month study

Locations

Country	Name	City	State
United States	Hancock County Health Department	Findlay	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Blanchard Valley Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A1c	Record Changes in HgbA1c	Baseline to 3 months
Primary	A1c	Record Changes in HgbA1c	Baseline to 6 months
Primary	A1c	Record Changes in HgbA1c	Baseline to 9 months
Primary	A1c	Record Changes in HgbA1c	Baseline to 12 months
Secondary	Weight	Record Changes	Baseline to 3 months
Secondary	Weight	Record Changes	Baseline to 6 months
Secondary	Weight	Record Changes	Baseline to 9 months
Secondary	Weight	Record Changes	Baseline to 12 months
Secondary	BMI	Record Changes	Baseline to 3 months
Secondary	BMI	Record Changes	Baseline to 6 months
Secondary	BMI	Record Changes	Baseline to 9 months
Secondary	BMI	Record Changes	Baseline to 12 months
Secondary	Percent Time in Range (70-180 mg/dl)	Record Changes	Baseline to 3 months
Secondary	Percent Time in Range (70-180 mg/dl)	Record Changes	Baseline to 6 months
Secondary	Percent Time in Range (70-180 mg/dl)	Record Changes	Baseline to 9 months
Secondary	Percent Time in Range (70-180 mg/dl)	Record Changes	Baseline to 12 months
Secondary	Percent Time in Hypoglycemia (<70 mg/dl)	Record Changes	Baseline to 3 months
Secondary	Percent Time in Hypoglycemia (<70 mg/dl)	Record Changes	Baseline to 6 months
Secondary	Percent Time in Hypoglycemia (<70 mg/dl)	Record Changes	Baseline to 9 months
Secondary	Percent Time in Hypoglycemia (<70 mg/dl)	Record Changes	Baseline to 12 months
Secondary	Percent Time in Hyperglycemia (>180 mg/dl)	Record Changes	Baseline to 3 months
Secondary	Percent Time in Hyperglycemia (>180 mg/dl)	Record Changes	Baseline to 6 months
Secondary	Percent Time in Hyperglycemia (>180 mg/dl)	Record Changes	Baseline to 9 months
Secondary	Percent Time in Hyperglycemia (>180 mg/dl)	Record Changes	Baseline to 12 months
Secondary	Quality of Life - GMSS T2DM Version	Record Changes in QoL	Baseline to 6 months
Secondary	Quality of Life - GMSS T2DM Version	Record Changes in QoL	Baseline to 12 months