Hyperglycemia, Hypoglycemia, Hypoglycemia Unawareness, Type 1 Diabetes, Type2 Diabetes
Conditions
Brief summary
The purpose of this study is to look at feasibility (the likelihood) of continued use of the FreeStyle Libre 2 Continuous glucose monitor (CGM) when started at the time of hospital discharge in patients with poorly controlled diabetes and to look at the effects of CGM use on blood glucose control and quality of life. Additional information will be collected to determine the barriers to continuing CGM use after discharge. The investigators will also collect information to see how well blood glucose has been controlled after discharge while utilizing the CGM.
Detailed description
VISIT/PHONE CALL WHAT WILL HAPPEN? (estimated time) \[window\] Screening Visit (\ 45 minutes) Review consent form and obtain consent Complete questionnaire, obtain diabetes history Day of Discharge (\ 1 hour) Complete FreeStyle Libre 2 CGM education Attach FreeStyle Libre 2 CGM sensor to arm Within 1-3 weeks from discharge Phone Call (\ 30 minutes) Questions regarding use of FreeStyle Libre 2 CGM Current diabetes regimen Adverse Events Reminder to take FreeStyle Libre 2 CGM sensor prescription to pharmacy to be filled 1 & 3 Month Phone Call (\ 45 minutes) \[+/- 5 days\] Questions regarding use of FreeStyle Libre 2 CGM Current diabetes regimen Complete questionnaire Adverse Events 6 Month Phone Call (\ 15 minutes) \[+/- 10 days\] Questions regarding use of FreeStyle Libre 2 CGM Barriers to FreeStyle Libre 2 CGM use Validated Instruments: Diabetes self-management Questionnaire (DMSQ)
Interventions
DEVICECGM4Home
FreeStyle Libre 2 Continuous Glucose Monitoring System manufactured by Abbott
Sponsors
Washington University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 18 years of age or older 2. Have diabetes (type 1 diabetes mellitus, type 2 diabetes mellitus, cystic fibrosis related diabetes mellitus) 3. Hemoglobin A1c greater than or equal to 8.0% or history of hypoglycemia unawareness 4. Able and willing to sign informed consent form 5. Have a valid telephone number 6. Willing to purchase FreeStyle Libre 2 CGM sensors out of pocket after discharge from hospital (when insurance coverage isn't available)
Exclusion criteria
1. Unable to sign informed consent form 2. Have altered mental status 3. Unable to manage diabetes independently at home 4. Have utilized CGM in the past 5. Pregnancy 6. New steroid-induced hyperglycemia 7. Unwilling to participate in the study 8. Have kidney disease requiring hemodialysis 9. Taking high doses of vitamin C daily (greater than 500 mg every day)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To Determine the Feasibility of Initiating a Continuous Glucose Monitoring in Patients With Diabetes at Hospital Discharge | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Time in Range Outcomes | At 1 month and 3 months | Mean and SD of Time below target, in target and above target at 1 month and 3 months |
| Percentage of Patients That Discontinue the CGM | At 6 months | Discontinuation rate, measured by percentage of patients that discontinue the CGM at 6 months with wearing device, use, costs, getting refills, etc.) |
| Mean Change in Self-efficacy at 3 Months | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | CGM Intervention |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants |
| Age, Continuous | 49 years STANDARD_DEVIATION 13.7 |
| Race/Ethnicity, Customized Black Non Hispanic | 9 Participants |
| Race/Ethnicity, Customized Hispanic/Latino | 1 Participants |
| Race/Ethnicity, Customized White, Non Hispanic | 10 Participants |
| Region of Enrollment United States | 20 Participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
To Determine the Feasibility of Initiating a Continuous Glucose Monitoring in Patients With Diabetes at Hospital Discharge
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.
Time frame: At 3 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CGM Intervention | To Determine the Feasibility of Initiating a Continuous Glucose Monitoring in Patients With Diabetes at Hospital Discharge | Lost to follow up | 13 Participants |
| CGM Intervention | To Determine the Feasibility of Initiating a Continuous Glucose Monitoring in Patients With Diabetes at Hospital Discharge | Discontinued use at 3 months | 3 Participants |
| CGM Intervention | 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
Mean Change in Self-efficacy at 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
Time frame: Baseline and 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CGM Intervention | Mean Change in Self-efficacy at 3 Months | 30.66 score on a scale | Standard Deviation 8.2 |
| 3-month | Mean Change in Self-efficacy at 3 Months | 40.8 score on a scale | Standard Deviation 7.8 |
Secondary
Mean Time in Range Outcomes
Mean and SD of Time below target, in target and above target at 1 month and 3 months
Time frame: At 1 month and 3 months
Population: Data was not collected
Secondary
Percentage of Patients That Discontinue the CGM
Discontinuation rate, measured by percentage of patients that discontinue the CGM at 6 months with wearing device, use, costs, getting refills, etc.)
Time frame: At 6 months
Population: Participants lost to follow up were counted as discontinued
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CGM Intervention | Percentage of Patients That Discontinue the CGM | 20 Participants |