Type 1 Diabetes, Type 2 Diabetes
Conditions
Brief summary
The objective of this study was to evaluate a virtual diabetes clinic model, for adults with either type 1 diabetes or type 2 diabetes, that supports integration of CGM into diabetes self-management and use of decision support technology.
Detailed description
Although demand for endocrinology care continues to grow, access to specialized care may be impacted by geographic isolation and a shortage in the number of endocrinologists in the United States. CGM use has been endorsed for individuals with T1D by the American Diabetes Association, the American Association of Clinical Endocrinologists, the Endocrine Society, and the International Society for Pediatric and Adolescent Diabetes. Despite these recommendations and the compelling evidence of the benefits of CGM, many individuals with T1D or insulin-using T2D have not incorporated CGM into their diabetes management. The study was designed to assess feasibility and efficacy of establishing a virtual diabetes clinic with a focus on introduction and training related to use of CGM technology and ongoing CGM use to minimize such rate-limiting factors as geography, cost and access to specialty care. The virtual diabetes clinic model included a comprehensive care team with support for diabetes technology such as CGM and decision support to align with current recommendations in diabetes care. The virtual diabetes clinic model also included mental health screening and support services, particularly for diabetes-related issues.
Interventions
OTHERVirtual Clinic
CGM, Clinical Care Support and Behavioral Health Support
Sponsors
Jaeb Center for Health Research
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. Age \>18 years old 2. Diagnosis of type 1 diabetes or type 2 diabetes and using insulin therapy (at least 3 injections of insulin per day or insulin pump that is compatible with Tidepool software); Multiple daily injection (MDI) users must be willing to use a device provided by the study that records the injection dosages and/or enter insulin dosing information through an app 3. See a healthcare provider at least once a year 4. Resident of United States and plan to reside in the U.S. for the duration of the study (This requirement is due to virtual clinic license requirements and U.S. use restrictions for some study software and devices. Not all U.S. states may be eligible for inclusion due to virtual clinic license status.) 5. Use either an Android or iOS smartphone that is compatible with app requirements that are needed for the study 6. Access to a compatible computer with internet 7. Understand written and spoken English 8. Willing and able to follow the study procedures as instructed
Exclusion criteria
1. Current use of a closed loop system where an insulin pump and CGM share information and insulin dose is automatically adjusted based on glucose reading 2. Current CGM use where Time in Range is ≥60.0% or Time \<54% is ≤1.0%. 3. Current use of any off-label glucose-lowering medications for diabetes type (Example: T1D use of non-insulin, anti-diabetic medications including SGLT2 inhibitors). Use of such medications during the study will also be prohibited. 4. Females who are pregnant, intending to become pregnant, or breastfeeding during the study 5. Current renal dialysis or plan to begin renal dialysis during the study 6. Active cancer treatment 7. Extreme visual or hearing impairment that would impair ability to use real-time CGM 8. Known adhesive allergy/prior skin reaction or skin reaction identified during the blinded CGM use phase that would preclude continued CGM use 9. Participation in a different diabetes management study during the study 10. Planned relocation to a state other than current state of residence during the study if virtual clinic is not licensed in the new state. Individuals working routinely in a state other than current state of residence in the next six months are also ineligible if the virtual clinic is not licensed in that state.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin A1C (HbA1c) | 26 weeks | Percentage of red blood cells with glucose coated hemoglobin |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time Spent With Glucose 70-180 mg/dL | 26 weeks | Percentage of 24 hour period with blood glucose in target range of 70-180 mg/dL |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants All participants were provided with a commercially available CGM system. Training and data collection for the study was completed remotely. After initial CGM training (initiation of unblinded CGM use or initial training with virtual clinic) was completed, participants were followed by the virtual clinic team for approximately six months. Psychosocial screening questionnaires were administered at enrollment and during follow up. The virtual clinical team member followed up with the study participant if there was an elevated score on the psychosocial screening questionnaires. After the initial six months of follow up, participants who decided to continue to use CGM were asked to extend follow up and complete questionnaires, submit HbA1c samples, and share data. During the extended follow up phase, participants were able to contact the virtual clinic with questions or to request assistance as needed.
Virtual Clinic: CGM, Clinical Care Support and Behavioral Health Support | 234 |
| Total | 234 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 47 years STANDARD_DEVIATION 14 |
| Hemoglobin A1c | 63 mmol/mol STANDARD_DEVIATION 17.5 |
| Race/Ethnicity, Customized African American | 20 Participants |
| Race/Ethnicity, Customized American Indian-Alaskan Native | 1 Participants |
| Race/Ethnicity, Customized Asian | 8 Participants |
| Race/Ethnicity, Customized Do not wish to answer | 7 Participants |
| Race/Ethnicity, Customized Other | 11 Participants |
| Race/Ethnicity, Customized White | 187 Participants |
| Sex: Female, Male Female | 123 Participants |
| Sex: Female, Male Male | 111 Participants |
| Time Spent with Glucose 70-<180 mg/dL | 49 percentage of 24 hour period STANDARD_DEVIATION 25 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 234 |
| other Total, other adverse events | 22 / 234 |
| serious Total, serious adverse events | 16 / 234 |
Outcome results
Primary
Hemoglobin A1C (HbA1c)
Percentage of red blood cells with glucose coated hemoglobin
Time frame: 26 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Hemoglobin A1C (HbA1c) | 54 mmol/mol | Standard Deviation 10.9 |
Secondary
Time Spent With Glucose 70-180 mg/dL
Percentage of 24 hour period with blood glucose in target range of 70-180 mg/dL
Time frame: 26 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Time Spent With Glucose 70-180 mg/dL | 63 percentage of 24 hour period | Standard Deviation 18 |