Type 2 Diabetes
Conditions
Keywords
diabetes, continuous glucose monitor, telehealth, federally qualified health center
Brief summary
The purpose of this study is to improve T2DM (type 2 diabetes mellitus) management and health outcomes among underserved patients who receive primary care at a federally qualified health center (FQHC) in Winnebago County, Illinois. Our aim is to assess the feasibility and preliminary effectiveness of a pilot program combining continuous glucose monitoring (CGM) with monthly telehealth appointments to improve diabetes management in FQHC patients who have uncontrolled T2DM (HbA1c \>7%). Researchers will compare those who receive the intervention (usual in-person care + CGM + 2 telehealth visits with a clinical pharmacist and family medicine resident) with those receiving a CGM in additional to usual care (in-person care + CGM). Participants will have their HbA1c tested and complete surveys to assess diabetes-related distress and diabetes management self-efficacy at baseline and 3 and 6 months from baseline. This will allow the investigators to raise glucose awareness for all participants utilizing CGM technology while simultaneously determining the necessity of more frequent follow-up than the guideline recommended intervals of 3 months for uncontrolled diabetes in an under-resourced population. This will also allow us to evaluate the feasibility of telehealth in delivering more frequent follow-up care to patients with T2DM.
Interventions
OTHERCGM plus telehealth
Participants will receive CGM supplies for 3 months plus 2 monthly telehealth appointments.
OTHERCGM only
Participants will receive CGM supplies for 3 months
Sponsors
University of Illinois at Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient receiving primary care from the study clinical site * Uncontrolled T2DM (HbA1c \>7%) * 18 years of age and older
Exclusion criteria
* Patients younger than 18 years of age * Patients in correctional facilities * Pregnant or lactating women * Current Continuous Glucose Monitoring device (CGM) users * Patients with gestational diabetes mellitus or Type 1 diabetes mellitus
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | Enrollment, 3 months, and 6 months | Hemoglobin A1c |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diabetes-related distress | Enrollment, 3 months, and 6 months | Diabetes-related distress as assessed by the TYPE 2 DIABETES DISTRESS ASSESSMENT SYSTEM (T2-DDAS) |
| Diabetes Management Self-Efficacy | Baseline, 3 months, and 6 months | Diabetes management self-efficacy as assessed by the Stanford English Diabetes Self-Management study diabetes self-efficacy questionnaire. Stanford English Diabetes Self-Management study. Study reported in Lorig K, Ritter PL, Villa FJ, Armas J. Community-Based Peer-Led Diabetes Self-Management: A Randomized Trial. The Diabetes Educator 2009; Jul-Aug;35(4):641-51. |
Countries
United States
Outcome results
None listed