Evaluation of a Single Center Expansion of Continuous Glucose Monitor Access in Patients With Type 2 Diabetes

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Device: Continuous glucose monitor

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.

• Study Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Syracuse, New York, United States, 13202
      • Upstate Health Care Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Continuous Glucose Monitor; Adult patients with Type 2 Diabetes on any anti-diabetic regimen utilizing continuous glucose monitors for 3 months	Device: Continuous glucose monitor; FreeStyle Libre 2 system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in percent time in range of 70-180mg/dL (%TIR)	Percentage	From baseline and at 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Glucose Monitoring Satisfaction Survey (GMSS) scores	Numeric number	From baseline and at 3 month
Change in %TIR	Percentage	From baseline and at 1 month
Change in %TIR	Percentage	From baseline and at 2 months
Change in hemoglobin A1c	Percentage	From baseline and at 3 months
Change in Percent Time Active	Percentage	From baseline and at 1 month
Change in Percent Time Active	Percentage	From baseline and at 2 months
Change in Percent Time Active	Percentage	From baseline and at 3 months
Change in Percent Time Below Range less than 54mg/dL (%TBR <54mg/dL)	Percentage	From baseline and at 1 month
Change in %TBR <54mg/dL	Percentage	From baseline and at 2 months
Change in %TBR <54mg/dL	Percentage	From baseline and at 3 months
Change in Percent Time Below Range less than 70mg/dL (%TBR <70mg/dL)	Percentage	From baseline and at 1 month
Change in %TBR <70mg/dL	Percentage	From baseline and at 2 months
Change in %TBR <70mg/dL	Percentage	From baseline and at 3 months
Change in Percent Time Above Range more than 180mg/dL (%TAR >180mg/dL)	Percentage	From baseline and at 1 month
Change in %TAR >180mg/dL	Percentage	From baseline and at 2 months
Change in %TAR >180mg/dL	Percentage	From baseline and at 3 months
Change in Percent Time Above Range more than 250mg/dL (%TAR >250mg/dL)	Percentage	From baseline and at 1 month
Change in %TAR >250mg/dL	Percentage	From baseline and at 2 months
Change in %TAR >250mg/dL	Percentage	From baseline and at 3 months
Change in Percent Coefficient of Variation (%CV)	Percentage	From baseline and at 1 month
Change in %CV	Percentage	From baseline and at 2 months
Change in %CV	Percentage	From baseline and at 3 months
Percentage of patients at goal %TIR	Percentage	1 month
Percentage of patients at goal %TIR	Percentage	2 months
Percentage of patients at goal %TIR	Percentage	3 months
Percentage of patients at goal % Time Active	Percentage	1 month
Percentage of patients at goal % Time Active	Percentage	2 months
Percentage of patients at goal % Time Active	Percentage	3 months
Percentage of patients at goal %TBR <54mg/dL	Percentage	1 month
Percentage of patients at goal %TBR <54mg/dL	Percentage	2 months
Percentage of patients at goal %TBR <54mg/dL	Percentage	1, 2, and
Percentage of patients at goal %TBR <70mg/dL	Percentage	1 month
Percentage of patients at goal %TBR <70mg/dL	Percentage	2 months
Percentage of patients at goal %TBR <70mg/dL	Percentage	3 months
Percentage of patients at goal %TAR >180mg/dL	Percentage	1 month
Percentage of patients at goal %TAR >180mg/dL	Percentage	2 months
Percentage of patients at goal %TAR >180mg/dL	Percentage	3 months
Percentage of patients at goal %TAR >250mg/dL	Percentage	1 month
Percentage of patients at goal %TAR >250mg/dL	Percentage	2 months
Percentage of patients at goal %TAR >250mg/dL	Percentage	3 months
Percentage of patients at goal % CV	Percentage	1 month
Percentage of patients at goal % CV	Percentage	2 months
Percentage of patients at goal % CV	Percentage	3 months

Collaborators and Investigators

• Sponsor: Chieh Chen
• Collaborators: St. John Fisher College
• Investigators: Principal Investigator: Elizabeth Phillips, PharmD, CACP, St. John Fisher College

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2022
• Primary Completion (Anticipated): November 1, 2022
• Study Completion (Anticipated): February 1, 2023

Study Registration Dates

• First Submitted: January 6, 2022
• First Submitted That Met QC Criteria: January 6, 2022
• First Posted (Actual): January 20, 2022

Study Record Updates

• Last Update Posted (Actual): May 4, 2022
• Last Update Submitted That Met QC Criteria: May 3, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: continuous glucose monitor; health disparity; pharmacists; FreeStyle Libre 2
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 1788320

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No