Status:
UNKNOWN
Community Glucose Monitoring Project
Lead Sponsor:
Blanchard Valley Health System
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18+ years
Phase:
NA
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), ...
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- 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
Key Trial Info
Start Date :
May 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT05351190
Start Date
May 15 2022
End Date
December 31 2024
Last Update
March 9 2023
Active Locations (1)
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1
Hancock County Health Department
Findlay, Ohio, United States, 45840