Status:

UNKNOWN

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

Lead Sponsor:

Chieh Chen

Collaborating Sponsors:

St. John Fisher College

Conditions:

Type 2 Diabetes

Eligibility:

All Genders

18+ years

Phase:

NA

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. Ho...

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...

Eligibility Criteria

Inclusion

  • 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

Exclusion

  • 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

Key Trial Info

Start Date :

January 24 2022

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

February 1 2023

Estimated Enrollment :

15 Patients enrolled

Trial Details

Trial ID

NCT05200390

Start Date

January 24 2022

End Date

February 1 2023

Last Update

May 4 2022

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Upstate Health Care Center

Syracuse, New York, United States, 13202

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