This non-blinded, non-randomized pre-post study will examine the impact of providing CGM sensors free of charge to adult patients of Fair Haven Community Health Care with poorly controlled type 2 diabetes on glycemic control and quality of life.
This study will enroll adult patients with type 2 diabetes and A1c of 8.0 or greater despite long-term use of insulin who are underinsured and under-resourced , meaning they are unable to reasonably afford CGM sensors. The participants will be chosen from among the panels of three providers. This study aims to determine whether providing CGMs free of charge to patients with poorly controlled diabetes who could not otherwise afford them positively impacts their glycemic control and quality of life. FHCHC's clinicians will identify adult patients from their panel with type 2 diabetes and poor glycemic control (A1c at least 8) on insulin who may be unable to afford CGM. Once consented, participants will have point-of-care A1c testing as well as pregnancy testing (if applicable); patient eligibility based on glycemic control criterion should be determined by this A1c. Participants will then complete the study questionnaires. Clinic staff will teach CGM sensor placement and determine whether a reader is required or if a compatible mobile device for intermittent scanning will be used. Blood Glucose (BG) readings are provided via online Libre portal. At the 6-week follow-up visit, the provider will recommend adjustments to the participant's medication regimen based on their BG trends on CGM and their clinical judgment. Providers will ask participants to report any adverse events, safety issues, or trouble with the CGM system thus far experienced. At the 12-week follow-up visit, participants will repeat completion of study questionnaires and undergo second A1c measurement. Further adjustment to medication regimen is permitted as provider sees fit. At the 24-week follow-up visit, participants will repeat completion of study questionnaires for a third time and undergo third A1c measurement.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
17
The first CGM sensor will be applied as directed during the first visit with a brief training by staff. Participant will be instructed to remove and replace the device every 14 days for the remainder of the 3-month trial period. Participant will also be instructed to scan the sensor three times daily. Compliance may be tracked via remote accessing of the blood glucose log on the online FreeStyle portal. CGM models used will include the Abbott FreeStyle Libre 2 and 3 and Dexcom G5, G6 and G7.
Fair Haven Community Health Care (FHCHC)
New Haven, Connecticut, United States
RECRUITINGMean Illness Intrusiveness Ratings Scale score (IIRS)
The IIRS is a useful, easy-to-apply tool that measures the degree of illness-induced disruptions in the 13 different aspects of life. Total score range from 13 (minimal intrusiveness) to 91 (extreme intrusiveness).
Time frame: Baseline, 12 weeks, 24 weeks
Mean Hemoglobin A1c concentration
Mean A1c concentration in mg/dL measured in blood samples
Time frame: Baseline, 12 weeks, 24 weeks
Mean Treatment Burden Questionnaire (TBQ) score
The TBQ is composed of 13 items rated on a Likert scale ranging from 0 (not a problem), to 10 (big problem). Item scores can be summed into a total score, ranging from 0 to 130. Higher scores indicate higher burden.
Time frame: Baseline, 12 weeks, 24 weeks
Mean Diabetes Distress Scale score (DDS-17)
DDS-17 is a 17-item measure that uses a Likert scale with each item scored from 1 (no distress) to 6 (serious distress) concerning distress experienced over the last month. Total score range from 1 to 6 with higher scores indicating more distress.
Time frame: Baseline, 12 weeks, 24 weeks
Mean Summary of Diabetes Self-Care Activities (SDSCA) score
The SDSCA is a brief self-report questionnaire of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: general diet, specific diet, exercise, blood-glucose testing, foot care, and smoking.Total score range is 7-70. Higher scores indicate more days spent doing diabetes self-care activities (such as checking blood sugar, following a diet plan, and participating in exercise activities).
Time frame: Baseline, 12 weeks, 24 weeks
Score on digital supplement to TBQ (TBQ+D)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The TBQ+D adds an additional 6 items to the TBQ, each rated on a Likert scale ranging from 0 (not a problem) to 10 (big problem). Item scores can be summed into a total score, ranging from 0 to 60. Higher scores indicate higher burden incurred by the use of digital health devices.
Time frame: Baseline, 12 weeks, 24 weeks
Quality of life analogue scale
This scale asks respondents to rate how diabetes has affected their quality of life over the last 2 weeks on a scale from 0 (the worst it has ever been) to 10 (the best it has ever been). Higher scores indicate better perceived quality of life.
Time frame: Baseline, 12 weeks, 24 weeks
TBQ+D Cognitive Interview tool
Cognitive Interview Tool: 10 participants will be asked to complete the TBQ+D survey aloud and provide their thoughts about the questions included. These recordings will be transcribed and evaluated qualitatively for recurrent themes.
Time frame: Baseline, 12 weeks, 24 weeks