Trial Outcomes & Findings for Continuous Glucose Monitoring Initiation at Hospital Discharge (NCT NCT04854135)

Results Overview

Starting and continuing to use a CGM at this critical time is feasible. Feasibility is defined as at least 20 percent of patients with diabetes referred for diabetes education meet inclusion criteria to participate and at least 75 percent participate. From those who participate, at least 50 percent continue using the CGM at 3 months.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

At 3 months

Results posted on

2024-02-16

Participant Flow

Participant milestones

Participant milestones
Measure	CGM Intervention All eligible patients will receive a Continuous Glucose Monitor (CGM) prior to hospital discharge after signing an informed consent. CGM4Home: FreeStyle Libre 2 Continuous Glucose Monitoring System manufactured by Abbott
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Continuous Glucose Monitoring Initiation at Hospital Discharge

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CGM Intervention n=20 Participants All eligible patients will receive a Continuous Glucose Monitor (CGM) prior to hospital discharge after signing an informed consent. CGM4Home: FreeStyle Libre 2 Continuous Glucose Monitoring System manufactured by Abbott
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	49 years STANDARD_DEVIATION 13.7 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Race/Ethnicity, Customized Black Non Hispanic	9 Participants n=5 Participants
Race/Ethnicity, Customized White, Non Hispanic	10 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic/Latino	1 Participants n=5 Participants
Region of Enrollment United States	20 Participants n=5 Participants

PRIMARY outcome

Timeframe: At 3 months

Starting and continuing to use a CGM at this critical time is feasible. Feasibility is defined as at least 20 percent of patients with diabetes referred for diabetes education meet inclusion criteria to participate and at least 75 percent participate. From those who participate, at least 50 percent continue using the CGM at 3 months.

Outcome measures

Outcome measures
Measure	CGM Intervention n=20 Participants All eligible patients will receive a Continuous Glucose Monitor (CGM) prior to hospital discharge after signing an informed consent. CGM4Home: FreeStyle Libre 2 Continuous Glucose Monitoring System manufactured by Abbott	3-month All eligible patients will receive a Continuous Glucose Monitor (CGM) prior to hospital discharge after signing an informed consent. CGM4Home: FreeStyle Libre 2 Continuous Glucose Monitoring System manufactured by Abbott
To Determine the Feasibility of Initiating a Continuous Glucose Monitoring in Patients With Diabetes at Hospital Discharge Lost to follow up	13 Participants	—
To Determine the Feasibility of Initiating a Continuous Glucose Monitoring in Patients With Diabetes at Hospital Discharge Discontinued use at 3 months	3 Participants	—
To Determine the Feasibility of Initiating a Continuous Glucose Monitoring in Patients With Diabetes at Hospital Discharge Continued use at 3 months	4 Participants	—

SECONDARY outcome

Timeframe: At 6 months

Population: Participants lost to follow up were counted as discontinued

Discontinuation rate, measured by percentage of patients that discontinue the CGM at 6 months with wearing device, use, costs, getting refills, etc.)

Outcome measures

Outcome measures
Measure	CGM Intervention n=20 Participants All eligible patients will receive a Continuous Glucose Monitor (CGM) prior to hospital discharge after signing an informed consent. CGM4Home: FreeStyle Libre 2 Continuous Glucose Monitoring System manufactured by Abbott	3-month All eligible patients will receive a Continuous Glucose Monitor (CGM) prior to hospital discharge after signing an informed consent. CGM4Home: FreeStyle Libre 2 Continuous Glucose Monitoring System manufactured by Abbott
Percentage of Patients That Discontinue the CGM	20 Participants	—

SECONDARY outcome

Timeframe: At 1 month and 3 months

Population: Data was not collected

Mean and SD of Time below target, in target and above target at 1 month and 3 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and 3 months

Using the Diabetes self-management Questionnaire (DMSQ), the investigators will measure the mean change and SD in the score (pre- and post- intervention) score is 0-48, higher scores mean a better outcome

Outcome measures

Outcome measures
Measure	CGM Intervention n=12 Participants All eligible patients will receive a Continuous Glucose Monitor (CGM) prior to hospital discharge after signing an informed consent. CGM4Home: FreeStyle Libre 2 Continuous Glucose Monitoring System manufactured by Abbott	3-month n=5 Participants All eligible patients will receive a Continuous Glucose Monitor (CGM) prior to hospital discharge after signing an informed consent. CGM4Home: FreeStyle Libre 2 Continuous Glucose Monitoring System manufactured by Abbott
Mean Change in Self-efficacy at 3 Months	30.66 score on a scale Standard Deviation 8.2	40.8 score on a scale Standard Deviation 7.8

Adverse Events

CGM Intervention

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

Paulina Cruz Bravo, MD

Washington University in St. Louis

Phone: 314-922-8620

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place