Low-Intensity mental health Support via a Telehealth Enabled Network for adults with diabetes (LISTEN): protocol for a hybrid type 1 effectiveness implementation trial.

BACKGROUND: Mental health problems are common among people with diabetes. However, evidence-based strategies for the prevention and early intervention of emotional problems in people with diabetes are lacking. Our aim is to assess the real-world effectiveness, cost-effectiveness, and implementation of a Low-Intensity mental health Support via a Telehealth Enabled Network (LISTEN), facilitated by diabetes health professionals (HPs). METHODS: A hybrid type I effectiveness-implementation trial, including a two-arm parallel randomised controlled trial, alongside mixed methods process evaluation. Recruited primarily via the National Diabetes Services Scheme, Australian adults with diabetes (N = 454) will be eligible if they are experiencing elevated diabetes distress. Participants are randomised (1:1 ratio) to LISTEN-a brief, low-intensity mental health support program based on a problem-solving therapy framework and delivered via telehealth (intervention) or usual care (web-based resources about diabetes and emotional health). Data are collected via online assessments at baseline (T0), 8 weeks (T1) and 6 months (T2, primary endpoint) follow-up. The primary outcome is between-group differences in diabetes distress at T2. Secondary outcomes include the immediate (T1) and longer-term (T2) effect of the intervention on psychological distress, general emotional well-being, and coping self-efficacy. A within-trial economic evaluation will be conducted. Implementation outcomes will be assessed using mixed methods, according to the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. Data collection will include qualitative interviews and field notes. DISCUSSION: It is anticipated that LISTEN will reduce diabetes distress among adults with diabetes. The pragmatic trial results will determine whether LISTEN is effective, cost-effective, and should be implemented at scale. Qualitative findings will be used to refine the intervention and implementation strategies as required. TRIAL REGISTRATION: This trial has been registered with the Australian New Zealand Clinical Trials Registry (ACTRN: ACTRN12622000168752) on 1 February, 2022.

"Empowering Us": A community-led survey of real-world perspectives of adults with type 1 diabetes using insulin pumps and continuous glucose monitoring to manage their glucose levels.

OBJECTIVE: To conduct an Australian community-led survey of adults with type 1 diabetes (T1D), identifying priorities for, and barriers to, optimal use of advanced glucose management technologies. RESEARCH DESIGN AND METHODS: A 30-question online survey of current or past users of insulin pump therapy (IPT), real-time continuous glucose monitoring (RT-CGM), or intermittently scanned CGM (isCGM) explored perceptions regarding device design, access, education, outcomes, and support. RESULTS: Between November 2021 and January 2022, surveys were completed by 3,380 participants (age [mean ± SD] 45 ± 16 years; 62% female; 20 ± 14 years diabetes), with 55%, 82%, and 55% reporting experience with IPT, RT-CGM, and isCGM, respectively. Overall, most considered diabetes technology '(extremely) important' for maintaining target glucose levels (98%) and reducing hypoglycaemia severity and frequency (93%). For most, technology contributed positively to emotional well-being (IPT 89%; RT-CGM 91%; isCGM 87%), which was associated with device effectiveness in maintaining glucose in range, comfort, and convenience. Barriers included affordability (IPT 68%; RT-CGM 81%; isCGM 69%) and insufficient information for informed choices about device suitability (IPT 39%; RT-CGM 41%; isCGM 36%). CONCLUSIONS: Technology is perceived by adults with T1D as important for managing glycaemia and emotional well-being. Modifiable barriers to use include affordability, and information regarding device suitability.