Type 2 Diabetes Clinical Trial
Official title:
Closing the Gap in Health Disparities and Improving Health Outcomes: Evaluation of a Single Center Expansion of Continuous Glucose Monitor Access in Patients With Type 2 Diabetes
Verified date | May 2022 |
Source | State University of New York - Upstate Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this pilot study is to hopefully generate interest that will lead to more robust trials evaluating FreeStyle Libre 2 sensors in patients with type 2 diabetes on any diabetes regimen. Hopefully the trial will ultimately pave the way to future trials that will prompt clinicians, policymakers, and insurers to re-evaluate the current criteria defining the coverage of continuous glucose monitors (CGM). The objectives of the study are to 1) Determine if there is difference in diabetes control in adult participants with type 2 diabetes before and after management with FreeStyle Libre 2, 2) Compare participant satisfaction with glucose monitoring and diabetes distress in adult participants with type 2 diabetes before and after management with FreeStyle Libre 2 and 3) Compare the frequency of hypoglycemia in adult participants with type 2 diabetes before and after management with FreeStyle Libre 2.
Status | Enrolling by invitation |
Enrollment | 15 |
Est. completion date | February 2023 |
Est. primary completion date | November 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Diagnosis of Type 2 Diabetes with 1. Hemoglobin A1c above goal 6.5%-8% based on participant specific factors defined in the ADA guidelines (e.g. comorbidities and age) OR 2. Identified glycemic excursions, including hypoglycemia based on documented blood glucose readings of < 70 mg/dL via point-of-care glucose testing, lab testing or self-monitoring or reported signs and symptoms of hypoglycemia documented in the medical record - Referred and actively followed by pharmacy for at least 3 months prior to study enrollment - Have at least one encounter with pharmacist within the last 3 months - Have at least one A1c documented while under pharmacist care - On at least one anti-diabetic medication - Demonstrates willingness (at the discretion of the investigators) to scan the CGM several times a day - Demonstrates willingness (at the discretion of the investigators) to attend regular office visits or phone calls Exclusion Criteria: - Currently pregnant or actively trying to conceive - Receiving dialysis - Currently followed by the endocrinology clinic for diabetes - Current or past CGM use in the last 6 months prior to study enrollment - Participant meets criteria for insurance coverage of CGM - Known allergy to medical adhesive - Wearing any implanted medical device |
Country | Name | City | State |
---|---|---|---|
United States | Upstate Health Care Center | Syracuse | New York |
Lead Sponsor | Collaborator |
---|---|
Chieh Chen | St. John Fisher College |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in percent time in range of 70-180mg/dL (%TIR) | Percentage | From baseline and at 3 months | |
Secondary | Change in Glucose Monitoring Satisfaction Survey (GMSS) scores | Numeric number | From baseline and at 3 month | |
Secondary | Change in %TIR | Percentage | From baseline and at 1 month | |
Secondary | Change in %TIR | Percentage | From baseline and at 2 months | |
Secondary | Change in hemoglobin A1c | Percentage | From baseline and at 3 months | |
Secondary | Change in Percent Time Active | Percentage | From baseline and at 1 month | |
Secondary | Change in Percent Time Active | Percentage | From baseline and at 2 months | |
Secondary | Change in Percent Time Active | Percentage | From baseline and at 3 months | |
Secondary | Change in Percent Time Below Range less than 54mg/dL (%TBR <54mg/dL) | Percentage | From baseline and at 1 month | |
Secondary | Change in %TBR <54mg/dL | Percentage | From baseline and at 2 months | |
Secondary | Change in %TBR <54mg/dL | Percentage | From baseline and at 3 months | |
Secondary | Change in Percent Time Below Range less than 70mg/dL (%TBR <70mg/dL) | Percentage | From baseline and at 1 month | |
Secondary | Change in %TBR <70mg/dL | Percentage | From baseline and at 2 months | |
Secondary | Change in %TBR <70mg/dL | Percentage | From baseline and at 3 months | |
Secondary | Change in Percent Time Above Range more than 180mg/dL (%TAR >180mg/dL) | Percentage | From baseline and at 1 month | |
Secondary | Change in %TAR >180mg/dL | Percentage | From baseline and at 2 months | |
Secondary | Change in %TAR >180mg/dL | Percentage | From baseline and at 3 months | |
Secondary | Change in Percent Time Above Range more than 250mg/dL (%TAR >250mg/dL) | Percentage | From baseline and at 1 month | |
Secondary | Change in %TAR >250mg/dL | Percentage | From baseline and at 2 months | |
Secondary | Change in %TAR >250mg/dL | Percentage | From baseline and at 3 months | |
Secondary | Change in Percent Coefficient of Variation (%CV) | Percentage | From baseline and at 1 month | |
Secondary | Change in %CV | Percentage | From baseline and at 2 months | |
Secondary | Change in %CV | Percentage | From baseline and at 3 months | |
Secondary | Percentage of patients at goal %TIR | Percentage | 1 month | |
Secondary | Percentage of patients at goal %TIR | Percentage | 2 months | |
Secondary | Percentage of patients at goal %TIR | Percentage | 3 months | |
Secondary | Percentage of patients at goal % Time Active | Percentage | 1 month | |
Secondary | Percentage of patients at goal % Time Active | Percentage | 2 months | |
Secondary | Percentage of patients at goal % Time Active | Percentage | 3 months | |
Secondary | Percentage of patients at goal %TBR <54mg/dL | Percentage | 1 month | |
Secondary | Percentage of patients at goal %TBR <54mg/dL | Percentage | 2 months | |
Secondary | Percentage of patients at goal %TBR <54mg/dL | Percentage | 1, 2, and | |
Secondary | Percentage of patients at goal %TBR <70mg/dL | Percentage | 1 month | |
Secondary | Percentage of patients at goal %TBR <70mg/dL | Percentage | 2 months | |
Secondary | Percentage of patients at goal %TBR <70mg/dL | Percentage | 3 months | |
Secondary | Percentage of patients at goal %TAR >180mg/dL | Percentage | 1 month | |
Secondary | Percentage of patients at goal %TAR >180mg/dL | Percentage | 2 months | |
Secondary | Percentage of patients at goal %TAR >180mg/dL | Percentage | 3 months | |
Secondary | Percentage of patients at goal %TAR >250mg/dL | Percentage | 1 month | |
Secondary | Percentage of patients at goal %TAR >250mg/dL | Percentage | 2 months | |
Secondary | Percentage of patients at goal %TAR >250mg/dL | Percentage | 3 months | |
Secondary | Percentage of patients at goal % CV | Percentage | 1 month | |
Secondary | Percentage of patients at goal % CV | Percentage | 2 months | |
Secondary | Percentage of patients at goal % CV | Percentage | 3 months |
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