Diabetes Mellitus
Conditions
Keywords
continuous glucose monitoring
Brief summary
This is a pilot study. The purpose is to (1) provide access to continuous glucose monitoring (CGM) to patients (purchased through a grant) and (2) systematically record and analyze the results of the glucose monitoring by the clinical pharmacists at the clinic.
Interventions
DEVICEFreeStyle LibrePro CGM
a professional CGM device will be worn by the participant for up to 14 days
Sponsors
Virginia Commonwealth University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
1. adult 18 years of age or older 2. diagnosis of Type 1 or Type 2 diabetes 3. A1c greater than 8% 4. prescribed basal insulin plus either prandial insulin or a glucagon-like peptide-1 (GLP-1) receptor agonist
Exclusion criteria
1. pregnant or breast-feeding 2. on dialysis 3. not appropriate for CGM use based on clinical judgment by the investigators 4. patients with limited English proficiency
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in A1c | Baseline to week 12 | Change in A1c will be used to assess glycemic control |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Medication Changes | Baseline to week 12 | Data will be collected on what medication changes are made (changes in types of medications and doses) |
| Glycemic Variability | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 28 |
| Total | 28 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 14 |
Baseline characteristics
| Characteristic | CGM Intervention Arm | — |
|---|---|---|
| Age, Continuous | 68 years STANDARD_DEVIATION 11.9 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 28 participants | — |
| Sex: Female, Male Female | 16 Participants | — |
| Sex: Female, Male Male | 12 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 14 |
| other Total, other adverse events | 0 / 14 |
| serious Total, serious adverse events | 0 / 14 |
Outcome results
Primary
Change in A1c
Change in A1c will be used to assess glycemic control
Time frame: Baseline to week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CGM Intervention Arm | Change in A1c | -0.74 percent of hemoglobin | Standard Deviation 1.6 |
Secondary
Glycemic Variability
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
Time frame: Baseline to week 12
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CGM Intervention Arm | Glycemic Variability | Time in Therapeutic goal | -3.17 percent time in range | Standard Deviation 23.5 |
| CGM Intervention Arm | Glycemic Variability | Time in Hypoglycemia | 2.58 percent time in range | Standard Deviation 13.7 |
| CGM Intervention Arm | Glycemic Variability | Time in Hyperglycemia | 1.5 percent time in range | Standard Deviation 30.4 |
Secondary
Medication Changes
Data will be collected on what medication changes are made (changes in types of medications and doses)
Time frame: Baseline to week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CGM Intervention Arm | Medication Changes | 1.83 number of medication changes | Standard Deviation 0.5 |