An interventional study of Dexcom G6 CGM in Type 2 Diabetes, sponsored by Blanchard Valley Health System. Status unknown at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-09.
Sponsored by Blanchard Valley Health System · Not applicable, Interventional, and Treatment
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.
This is the only study on the registry with Blanchard Valley Health System as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
All participants will be given a rtCGM (Dexcom G6) to assess their glycemic control.
Device: Dexcom G6 CGM
rtCGM to be worn by user continuously for the duration of the 12 month study
A1c
Record Changes in HgbA1c
Time frame: Baseline to 3 months
A1c
Record Changes in HgbA1c
Time frame: Baseline to 6 months
A1c
Record Changes in HgbA1c
Time frame: Baseline to 9 months
A1c
Record Changes in HgbA1c
Time frame: Baseline to 12 months
Weight
Record Changes
Time frame: Baseline to 3 months
Weight
Record Changes
Time frame: Baseline to 6 months
Weight
Record Changes
Time frame: Baseline to 9 months
Weight
Record Changes
Time frame: Baseline to 12 months
BMI
Record Changes
Time frame: Baseline to 3 months
BMI
Record Changes
Time frame: Baseline to 6 months
BMI
Record Changes
Time frame: Baseline to 9 months
BMI
Record Changes
Time frame: Baseline to 12 months
Percent Time in Range (70-180 mg/dl)
Record Changes
Time frame: Baseline to 3 months
Percent Time in Range (70-180 mg/dl)
Record Changes
Time frame: Baseline to 6 months
Percent Time in Range (70-180 mg/dl)
Record Changes
Time frame: Baseline to 9 months
Percent Time in Range (70-180 mg/dl)
Record Changes
Time frame: Baseline to 12 months
Percent Time in Hypoglycemia (<70 mg/dl)
Record Changes
Time frame: Baseline to 3 months
Percent Time in Hypoglycemia (<70 mg/dl)
Record Changes
Time frame: Baseline to 6 months
Percent Time in Hypoglycemia (<70 mg/dl)
Record Changes
Time frame: Baseline to 9 months
Percent Time in Hypoglycemia (<70 mg/dl)
Record Changes
Time frame: Baseline to 12 months
Percent Time in Hyperglycemia (>180 mg/dl)
Record Changes
Time frame: Baseline to 3 months
Percent Time in Hyperglycemia (>180 mg/dl)
Record Changes
Time frame: Baseline to 6 months
Percent Time in Hyperglycemia (>180 mg/dl)
Record Changes
Time frame: Baseline to 9 months
Percent Time in Hyperglycemia (>180 mg/dl)
Record Changes
Time frame: Baseline to 12 months
Quality of Life - GMSS T2DM Version
Record Changes in QoL
Time frame: Baseline to 6 months
Quality of Life - GMSS T2DM Version
Record Changes in QoL
Time frame: Baseline to 12 months
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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