NCT05200390

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable type-2-diabetes

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 6, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 20, 2022

Completed
4 days until next milestone

Study Start

First participant enrolled

January 24, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

May 4, 2022

Status Verified

May 1, 2022

Enrollment Period

9 months

First QC Date

January 6, 2022

Last Update Submit

May 3, 2022

Conditions

Type 2 Diabetes

Keywords

continuous glucose monitorFreeStyle Libre 2health disparitypharmacists

Outcome Measures

Primary Outcomes (1)

  • Change in percent time in range of 70-180mg/dL (%TIR)

    Percentage

    From baseline and at 3 months

Secondary Outcomes (43)

  • Change in Glucose Monitoring Satisfaction Survey (GMSS) scores

    From baseline and at 3 month

  • Change in %TIR

    From baseline and at 1 month

  • Change in %TIR

    From baseline and at 2 months

  • Change in hemoglobin A1c

    From baseline and at 3 months

  • Change in Percent Time Active

    From baseline and at 1 month

  • +38 more secondary outcomes

Study Arms (1)

Continuous Glucose Monitor

EXPERIMENTAL

Adult patients with Type 2 Diabetes on any anti-diabetic regimen utilizing continuous glucose monitors for 3 months

Device: Continuous glucose monitor

Interventions

Continuous glucose monitorDEVICE

FreeStyle Libre 2 system

Continuous Glucose Monitor

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of Type 2 Diabetes with
  • Hemoglobin A1c above goal 6.5%-8% based on participant specific factors defined in the ADA guidelines (e.g. comorbidities and age) OR
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Upstate Health Care Center

Syracuse, New York, 13202, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Elizabeth Phillips, PharmD, CACP

    St. John Fisher College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Pharmacy Resident - PGY2

Study Record Dates

First Submitted

January 6, 2022

First Posted

January 20, 2022

Study Start

January 24, 2022

Primary Completion

November 1, 2022

Study Completion

February 1, 2023

Last Updated

May 4, 2022

Record last verified: 2022-05

Locations

US(1)