Community Glucose Monitoring Project

NCT05351190 | Unknown FDA Device

• 1 other identifier: IIS-2021-169
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (22)

• Weight

  Baseline to 3 months

• Weight

  Baseline to 6 months

• Weight

  Baseline to 9 months

• Weight

  Baseline to 12 months

• BMI

  Baseline to 3 months

Study Arms (1)

Treatment Arm

OTHER

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

Device: Dexcom G6 CGM

Interventions

Dexcom G6 CGM DEVICE

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

Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Blanchard Valley Health System: lead

Study Sites (1)

Hancock County Health Department

Findlay, Ohio, 45840, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Thomas Grace, MD

  Hancock County Health Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 18, 2022
• First Posted: April 28, 2022
• Study Start: May 15, 2022
• Primary Completion: August 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 9, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)