Clinical trial NCT05200390: Evaluation of a Single Center Expansion of Continuous Glucose Monitor Access in Patients With Type 2 Diabetes
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 2 Diabetes
Keywords: continuous glucose monitor
FreeStyle Libre 2
health disparity
pharmacists
Lead sponsor: State University of New York - Upstate Medical University
Sponsor class: OTHER
Collaborators: name: St. John Fisher College
First posted: 2022-01-20
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: This will be a prospective, single-center, pre-post pilot study where enrolled participants will be given free FreeStyle Libre 2 sensors for 3 months and will be followed by pharmacists in the Upstate Adult Medicine Clinic.

During the first visit, pharmacists will order a baseline hemoglobin A1c, confirm the participant's current medication list, provide CGM education and assess patient's willingness to scan. Participants will also be asked to participate in a voluntary initial satisfaction survey (Glucose Monitoring Satisfaction Survey). Sensors will be placed at the end of the first visit. No medication changes will be made in order to obtain baseline data for each participant. All initial visits will be conducted in-office. Baseline characteristics will be collected at this visit.

The second visit will be scheduled approximately 2 weeks after the initial visit and will also be in-office. Since no medication changes were made during the first visit, the second visit will provide baseline CGM data, which will be reviewed with the participant. All subsequent follow-up visits will be scheduled at 2-week intervals unless an earlier visit is determined to be necessary by the pharmacist. At the discretion of the pharmacists, subsequent follow-up visits can either be a telemedicine encounter or an in-office visit. CGM data and medication changes will be documented at each visit.

The final visit will be scheduled approximately 3 months after sensor placement and will be in-office. Participants will be asked to participate in the post satisfaction survey (Glucose Monitoring Satisfaction Survey). Pharmacists will repeat the hemoglobin A1c, review the final medication list, remove the sensors, and review plan for self-monitoring blood glucose with patient moving forward.

Eligibility criteria: 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

Primary outcomes:
measure: Change in percent time in range of 70-180mg/dL (%TIR)
timeFrame: From baseline and at 3 months
Secondary outcomes:
measure: Change in Glucose Monitoring Satisfaction Survey (GMSS) scores
timeFrame: From baseline and at 3 month
measure: Change in %TIR
timeFrame: From baseline and at 1 month
measure: Change in %TIR
timeFrame: From baseline and at 2 months
measure: Change in hemoglobin A1c
timeFrame: From baseline and at 3 months
measure: Change in Percent Time Active
timeFrame: From baseline and at 1 month
measure: Change in Percent Time Active
timeFrame: From baseline and at 2 months
measure: Change in Percent Time Active
timeFrame: From baseline and at 3 months
measure: Change in Percent Time Below Range less than 54mg/dL (%TBR <54mg/dL)
timeFrame: From baseline and at 1 month
measure: Change in %TBR <54mg/dL
timeFrame: From baseline and at 2 months
measure: Change in %TBR <54mg/dL
timeFrame: From baseline and at 3 months
measure: Change in Percent Time Below Range less than 70mg/dL (%TBR <70mg/dL)
timeFrame: From baseline and at 1 month
measure: Change in %TBR <70mg/dL
timeFrame: From baseline and at 2 months
measure: Change in %TBR <70mg/dL
timeFrame: From baseline and at 3 months
measure: Change in Percent Time Above Range more than 180mg/dL (%TAR >180mg/dL)
timeFrame: From baseline and at 1 month
measure: Change in %TAR >180mg/dL
timeFrame: From baseline and at 2 months
measure: Change in %TAR >180mg/dL
timeFrame: From baseline and at 3 months
measure: Change in Percent Time Above Range more than 250mg/dL (%TAR >250mg/dL)
timeFrame: From baseline and at 1 month
measure: Change in %TAR >250mg/dL
timeFrame: From baseline and at 2 months
measure: Change in %TAR >250mg/dL
timeFrame: From baseline and at 3 months
measure: Change in Percent Coefficient of Variation (%CV)
timeFrame: From baseline and at 1 month
measure: Change in %CV
timeFrame: From baseline and at 2 months
measure: Change in %CV
timeFrame: From baseline and at 3 months
measure: Percentage of patients at goal %TIR
timeFrame: 1 month
measure: Percentage of patients at goal %TIR
timeFrame: 2 months
measure: Percentage of patients at goal %TIR
timeFrame: 3 months
measure: Percentage of patients at goal % Time Active
timeFrame: 1 month
measure: Percentage of patients at goal % Time Active
timeFrame: 2 months
measure: Percentage of patients at goal % Time Active
timeFrame: 3 months
measure: Percentage of patients at goal %TBR <54mg/dL
timeFrame: 1 month
measure: Percentage of patients at goal %TBR <54mg/dL
timeFrame: 2 months
measure: Percentage of patients at goal %TBR <54mg/dL
timeFrame: 1, 2, and
measure: Percentage of patients at goal %TBR <70mg/dL
timeFrame: 1 month
measure: Percentage of patients at goal %TBR <70mg/dL
timeFrame: 2 months
measure: Percentage of patients at goal %TBR <70mg/dL
timeFrame: 3 months
measure: Percentage of patients at goal %TAR >180mg/dL
timeFrame: 1 month
measure: Percentage of patients at goal %TAR >180mg/dL
timeFrame: 2 months
measure: Percentage of patients at goal %TAR >180mg/dL
timeFrame: 3 months
measure: Percentage of patients at goal %TAR >250mg/dL
timeFrame: 1 month
measure: Percentage of patients at goal %TAR >250mg/dL
timeFrame: 2 months
measure: Percentage of patients at goal %TAR >250mg/dL
timeFrame: 3 months
measure: Percentage of patients at goal % CV
timeFrame: 1 month
measure: Percentage of patients at goal % CV
timeFrame: 2 months
measure: Percentage of patients at goal % CV
timeFrame: 3 months
Other outcomes:
Locations:
city: Syracuse
country: United States
facility: Upstate Health Care Center
state: New York
Study officials:
affiliation: St. John Fisher College
name: Elizabeth Phillips, PharmD, CACP
role: PRINCIPAL_INVESTIGATOR
References: