User Experiences of a Bihormonal Fully Closed-Loop System Among Adults with Type 1 Diabetes in a Real-World Setting:...

Bihormonal fully closed loop (FCL; "artificial pancreas") reactively manages glucose levels by adjusting insulin or glucagon delivery based on sensor readings. Previous quantitative research has demonstrated FCL group-level efficacy in terms of glycemic and person-reported outcomes. Less is known about specific user experiences and the impact on different life domains.

To qualitatively examine motives and user experiences related to this bihormonal FCL system among adults with type 1 diabetes in a real-world setting. This included (a) reasons for considering FCL use, (b) positive or negative impact of FCL, (c) the process of adjusting to the system, and (d) the perceived benefit-burden trade-off.

After close of a 12-month single-arm trial (FREE 1), a subsample was interviewed (n = 12). Eight ongoing users were selected based on change patterns in the quantitative trial data. Four people who discontinued the system were selected based on duration of FCL use and discontinuation reasons. Data were analyzed using thematic and narrative analysis.

Participants voiced a combination of personal and altruistic considerations in the decision to start FCL. While there was a variety in individual impact, benefits (improved glycemic outcomes, feeling more like a person without diabetes) mostly outweighed burdens (e.g., hassles related to glucagon replacement, multiple components, alarms). FCL was a positive life changer for ongoing users, despite continued effort required for technology management. Finding a working relation with the system was challenging and took time, with participants reporting different coping strategies. Discontinuation reasons presented early, with an accumulation of negative experiences leading up to the decision to stop.

FCL users experience improvements mostly in glycemic and often also person-reported outcomes, with continuation of use depending on reconcilability of technology hassles. To facilitate FCL adoption and long-term use, expectation management and continued support from the manufacturer and trained diabetes care teams seem key.