Trial Outcomes & Findings for Pharmacist-driven CGM Use in the Uninsured Population (NCT NCT03477838)

NCT ID: NCT03477838

Last Updated: 2021-02-05

Results Overview

Change in A1c will be used to assess glycemic control

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 28 participants
• Primary outcome timeframe: Baseline to week 12
• Results posted on: 2021-02-05

Participant Flow

Participant milestones

Measure	CGM Intervention Arm Patients eligible for care at the free clinic with diabetes and A1c greater than 8% on insulin therapy will be identified for CGM use. FreeStyle LibrePro CGM: a professional CGM device will be worn by the participant for up to 14 days
Overall Study STARTED	28
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	14

Reasons for withdrawal

Measure	CGM Intervention Arm Patients eligible for care at the free clinic with diabetes and A1c greater than 8% on insulin therapy will be identified for CGM use. FreeStyle LibrePro CGM: a professional CGM device will be worn by the participant for up to 14 days
Overall Study Lost to Follow-up	14

Baseline Characteristics

Age data was not collected from all participants.

Baseline characteristics by cohort

Measure	CGM Intervention Arm n=28 Participants Patients eligible for care at the free clinic with diabetes and A1c greater than 8% on insulin therapy will be identified for CGM use. FreeStyle LibrePro CGM: a professional CGM device will be worn by the participant for up to 14 days
Age, Continuous	68 years STANDARD_DEVIATION 11.9 • n=13 Participants • Age data was not collected from all participants.
Sex: Female, Male Female	16 Participants n=28 Participants
Sex: Female, Male Male	12 Participants n=28 Participants
Region of Enrollment United States	28 participants n=28 Participants

PRIMARY outcome

Timeframe: Baseline to week 12

Change in A1c will be used to assess glycemic control

Outcome measures

Measure	CGM Intervention Arm n=14 Participants Patients eligible for care at the free clinic with diabetes and A1c greater than 8% on insulin therapy will be identified for CGM use. FreeStyle LibrePro CGM: a professional CGM device will be worn by the participant for up to 14 days
Change in A1c	-0.74 percent of hemoglobin Standard Deviation 1.6

SECONDARY outcome

Timeframe: Baseline to week 12

Data will be collected on what medication changes are made (changes in types of medications and doses)

Outcome measures

Measure	CGM Intervention Arm n=14 Participants Patients eligible for care at the free clinic with diabetes and A1c greater than 8% on insulin therapy will be identified for CGM use. FreeStyle LibrePro CGM: a professional CGM device will be worn by the participant for up to 14 days
Medication Changes	1.83 number of medication changes Standard Deviation 0.5

SECONDARY outcome

Timeframe: Baseline to week 12

Data collected by the CGM, such as time-in-therapeutic range, will be evaluated to assess glycemic variability during the 14 day period of wearing the CGM

Outcome measures

Measure	CGM Intervention Arm n=14 Participants Patients eligible for care at the free clinic with diabetes and A1c greater than 8% on insulin therapy will be identified for CGM use. FreeStyle LibrePro CGM: a professional CGM device will be worn by the participant for up to 14 days
Glycemic Variability Time in Therapeutic goal	-3.17 percent time in range Standard Deviation 23.5
Glycemic Variability Time in Hypoglycemia	2.58 percent time in range Standard Deviation 13.7
Glycemic Variability Time in Hyperglycemia	1.5 percent time in range Standard Deviation 30.4

Adverse Events

CGM Intervention Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Evan Sisson, PharmD

Virginia Commonwealth University

Phone: 804-828-8076

Email: emsisson@vcu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place