Examining Share plus—A Continuous Glucose Monitoring Plus Data-Sharing Intervention in Older Adults and Their Care Partners: Protocol for a Randomized Control Study (Preprint)
Authors: Allen Nancy A , Berg Cynthia A , Iacob Eli , Gonzales Bruno Rodriguez , Butner Jonathan E , Litchman Michelle L 
Published: May 2024

BACKGROUND

Older adults with type 1 diabetes (T1D) are increasingly turning to care partners (CPs) as resources to support their diabetes management. With the rise in diabetes technologies, such as continuous glucose monitoring (CGM), there is great potential for CGM data sharing to increase CP involvement in a way that improves persons with diabetes’ glucose management and reduces distress.

OBJECTIVE

The specific aims of this paper are to (1) evaluate the feasibility, usability, and acceptability of the Share plus intervention compared to the CGM Follow app plus diabetes self-management education and support; (2) evaluate the effect of the Share plus intervention on time-in-range (TIR; primary outcome) and diabetes distress (secondary outcome); and (3) explore differences between groups in person with diabetes and CP dyadic appraisal and coping, quality of life, diabetes self-care, and CP burden at 12 and 24 weeks and associations of dyadic variables on outcomes.

METHODS

This is a protocol for a feasibility, pilot randomized controlled trial. Older adults with T1D and their CP (N=80 dyads) will be randomized 1:1 to the Share plus intervention or Follow app plus diabetes self-management education. The trial will include a 12-week active intervention to determine the change in primary (TIR) and secondary (diabetes distress) outcomes, followed by a 12-week, observation-only phase to examine maintenance effects. The evaluation is guided by the Dyadic Coping Model. Patient-level effectiveness outcomes (TIR, hemoglobin A<sub>1c</sub> [HbA<sub>1c</sub>], diabetes distress, diabetes appraisal, coping, quality of life, diabetes self-care behaviors, and CP burden) will be assessed, using patient-reported outcomes measures and a home HbA<sub>1c</sub> test kit. Patient- and CP-level acceptability and feasibility will be assessed using surveys and interviews. Quantitative feasibility, acceptability, and usability data will be described using frequencies and percentages. Acceptability will be summarized based on Likert questions and open-ended questions. Usability will be examined separately for the intervention and control groups based on the System Usability Scale, with a study benchmark of ≥68 indicating good usability. TIR will be computed based on 2 weeks’ worth of data at baseline (prior to intervention) and 2 weeks each after the intervention (week 12) and at follow-up (week 24).

RESULTS

Recruitment started in August 2023 and enrollment began in November 2023. To date, 24 participants have been enrolled in this study. We expect to conclude this study in March 2026 and expect to disseminate results in March 2026.

CONCLUSIONS

To our knowledge, this will be the first pilot randomized controlled trial to evaluate both feasibility and effectiveness outcomes for the web-based, platform-delivered Share plus intervention for older adults with T1D and their CP. This research has implications for CGM data sharing in other age groups with T1D and type 2 diabetes.

CLINICALTRIAL

ClinicalTrials.gov NCT05937321; https://clinicaltrials.gov/study/NCT05937321

INTERNATIONAL REGISTERED REPORT

DERR1-10.2196/60004