Type 2 Diabetes
Conditions
Brief summary
Continuous glucose monitoring (CGM) has demonstrated improved outcomes in both type 1 and type 2 diabetes populations in comparison to traditional methods; however, these devices have not been well studied in underserved adult patients (e.g., low-income, uninsured) who may face additional barriers to monitoring. Furthermore, there is limited data exploring long-term (3- to 6- month) health care team-based management of these devices in the primary care setting. The purpose of this study is to further understand the benefits and barriers associated with CGM use in underserved populations with type 2 diabetes and improve their overall diabetes care.
Detailed description
Continuous glucose monitoring (CGM) has demonstrated improved outcomes in both type 1 and type 2 diabetes populations in comparison to traditional methods; however, these devices have not been well studied in underserved adult patients (e.g., low-income, uninsured) who may face additional barriers to monitoring. Furthermore, there is limited data exploring long-term (3- to 6- month) health care team-based management of these devices in the primary care setting. This study will evaluate the perceived and experienced benefits and barriers of continuous glucose monitor (CGM) and traditional glucometer use and identify diabetes related outcomes associated with CGM use relative to usual care with self-monitoring of blood glucose (SMBG) in an underserved population. Eligible adult (\>=19 years of age) patients at participating clinics with type 2 diabetes, A1c \>=9%, and concomitant insulin therapy and/or using two or more diabetes medications will be randomly enrolled to one of two groups: Freestyle Libre 2 CGM or traditional glucometer. Pre- and post-surveys will be used to evaluate perceived and experienced benefits and barriers to CGM use and diabetes-related outcomes will be compared between the groups using face-to-face, telephonic, and/or digital avenues. The latter aim will replicate current processes of team-based diabetes care which is blood glucose management from a pharmacist under collaborative practice with the primary care physician. Follow-up will also replicate these clinic processes throughout the 6-month period, including telephone calls and monthly in-clinic visits.
Interventions
DEVICEContinuous Glucose Monitor (CGM)
A Freestyle Libre 2 continuous glucose monitor (CGM) will be provided in the experimental arm of this study for 6 months.
DEVICESelf-monitoring Blood Glucose (SMBG)
A traditional glucometer device will be assigned in the active comparitor arm of this study for 6 months.
Sponsors
Great Plains IDeA-CTR
University of Nebraska
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants will be assigned to one of two groups and receive either the treatment intervention, continuous glucose monitor (CGM), or standard of care intervention ,traditional glucometer, upon enrollment.
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Type 2 diabetes * A1c \>9% at recruitment * On/initiating insulin or on two or more diabetes medications
Exclusion criteria
* Current use of an insulin pump * On dialysis * Pregnant * Implanted medical device (e.g., pace-maker, defibrillator) * Intellectual or physical disabilities that may interfere with ability to properly use the Continuous Glucose Monitor (CGM) * Able to read English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glycemic Control (Hemoglobin A1c) | Baseline, 3 months, and 6 months. | Glycemic control will be assessed by measuring hemoglobin A1c at baseline, 3 months, and 6 months. Values will be evaluated as a continuous variable and categorized as \<7.0% vs \>7.0% to \<9.0% and \>9.0%. Comparisons of the proportions of participants achieving a minimum of 1 point drop in hemoglobin A1c will be made between study arms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hypoglycemia | 6 months | Continuous glucose monitor (CGM) and glucometer blood glucose data will be evaluated to determine number and percentage of hypoglycemic readings (i.e., \<70 mg/dL). For CGM data, % time within target range, % time below specific thresholds for hypoglycemia) will be captured and described. |
| Hyperglycemia | 6 months | Continuous glucose monitor (CGM) and glucometer blood glucose data will be evaluated to determine percentage of hyperglycemic values (i.e., \>180 mg/dl) experienced. For CGM data, % time within target range, % time below specific thresholds for hypoglycemia) will be captured and described. |
| Blood Glucose Capture Rate | 6 months | Number of days without any blood glucose recordings will be captured as a percentage over the study period. |
| Perceived or Experienced Benefits and Barriers to Device Use | Baseline and 6 months | A pre- and post-survey will be provided to all participants to qualitatively identify benefits and barriers to access and use of their assigned device and willingness to continue CGM use (follow-up survey). |
Countries
United States
Outcome results
None listed