Clinical trial NCT05351190: Community Glucose Monitoring Project
Official title: Community Glucose Monitoring (CGM) Project
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 2 Diabetes
Lead sponsor: Blanchard Valley Health System
Sponsor class: OTHER
First posted: 2022-04-28
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: A1c
timeFrame: Baseline to 3 months
measure: A1c
timeFrame: Baseline to 6 months
measure: A1c
timeFrame: Baseline to 9 months
measure: A1c
timeFrame: Baseline to 12 months
Secondary outcomes:
measure: Weight
timeFrame: Baseline to 3 months
measure: Weight
timeFrame: Baseline to 6 months
measure: Weight
timeFrame: Baseline to 9 months
measure: Weight
timeFrame: Baseline to 12 months
measure: BMI
timeFrame: Baseline to 3 months
measure: BMI
timeFrame: Baseline to 6 months
measure: BMI
timeFrame: Baseline to 9 months
measure: BMI
timeFrame: Baseline to 12 months
measure: Percent Time in Range (70-180 mg/dl)
timeFrame: Baseline to 3 months
measure: Percent Time in Range (70-180 mg/dl)
timeFrame: Baseline to 6 months
measure: Percent Time in Range (70-180 mg/dl)
timeFrame: Baseline to 9 months
measure: Percent Time in Range (70-180 mg/dl)
timeFrame: Baseline to 12 months
measure: Percent Time in Hypoglycemia (<70 mg/dl)
timeFrame: Baseline to 3 months
measure: Percent Time in Hypoglycemia (<70 mg/dl)
timeFrame: Baseline to 6 months
measure: Percent Time in Hypoglycemia (<70 mg/dl)
timeFrame: Baseline to 9 months
measure: Percent Time in Hypoglycemia (<70 mg/dl)
timeFrame: Baseline to 12 months
measure: Percent Time in Hyperglycemia (>180 mg/dl)
timeFrame: Baseline to 3 months
measure: Percent Time in Hyperglycemia (>180 mg/dl)
timeFrame: Baseline to 6 months
measure: Percent Time in Hyperglycemia (>180 mg/dl)
timeFrame: Baseline to 9 months
measure: Percent Time in Hyperglycemia (>180 mg/dl)
timeFrame: Baseline to 12 months
measure: Quality of Life - GMSS T2DM Version
timeFrame: Baseline to 6 months
measure: Quality of Life - GMSS T2DM Version
timeFrame: Baseline to 12 months
Other outcomes:
Locations:
city: Findlay
country: United States
facility: Hancock County Health Department
state: Ohio
Study officials:
affiliation: Hancock County Health Department
name: Thomas Grace, MD
role: PRINCIPAL_INVESTIGATOR
References: