Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm | Other | All participants will be given a rtCGM (Dexcom G6) to assess their glycemic control. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexcom G6 CGM | Device | rtCGM to be worn by user continuously for the duration of the 12 month study |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Weight | Record Changes | Baseline to 3 months |
| Weight | Record Changes | Baseline to 6 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Thomas Grace, MD | Hancock County Health Department | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hancock County Health Department | Findlay | Ohio | 45840 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| 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 |
| 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 |
| D004700 | Endocrine System Diseases |