Digital Outpatient Care for Patients With Type 1 Diabetes (DigiDiaS): Pragmatic Observational Pre-Post Study

Background Patient-reported outcomes in digital health solutions can offer patients with type 1 diabetes an opportunity to voice their needs in outpatient care, enabling clinicians to tailor support. Evidence on long-term health impact and routine integration of such digital solutions outside controlled settings is limited. Objective This study aimed to compare a flexible digital supplement to outpatient care for type 1 diabetes (DigiDiaS) with usual care over 1 year, with self-management as the primary outcome and glycemic control and well-being as secondary outcomes. Methods This longitudinal real-world observational pre-post study was conducted at the Endocrinology Department of Akershus University Hospital in Norway. Adults with type 1 diabetes were recruited consecutively from October 2022 to October 2023 and could choose either the digital mobile health (mHealth)–based outpatient care model—“DigiDiaS” care—or usual care. DigiDiaS care is delivered via a smartphone app and includes a messaging service; patient-reported outcome–based preconsultation questionnaires; video, telephone, and in-person consultations; and an individually tailored information section. Outcome data comprised self-reported measures, clinical data extracted from electronic medical records, the national diabetes registry, and the digital platform. Data were collected at baseline and at the 1-year follow-up. Change in self-management (Patient Activation Measure short version [PAM-13]; primary outcome) and the secondary outcomes well-being (Five Well-Being Index [WHO-5]) and glycemic control (glycated hemoglobin [HbA1c]) were analyzed using a generalized linear model. Utilization of the digital solution and health care services was also explored. Results We included 237 patients, with 185 (78%) opting for DigiDiaS care and 52 (22%) for usual care. At the follow-up, most participants (145/178, 81%) in the DigiDiaS care group used the digital solution. The messaging service was the most utilized feature with 592 messages sent collectively (median 1, min-max 0-57). There were no statistically significant between-group differences in change from baseline to follow-up in self-management (mean difference 1.18, 95% CI –5.2 to 7.6; P=.72), glycemic control (HbA1c mean difference –2.1, 95% CI –6.6 to 2.4; P=.36), or well-being (mean difference 1.9, 95% CI –3.1 to 6.9; P=.46). Health care utilization did not differ between the groups, including participation in one or more individual consultations during the 1-year follow-up (DigiDiaS care: 159/178, 89%; usual care: 42/50, 84%; P=.30) or appointment cancellations (DigiDiaS care: 64/91, 70%; usual care: 13/18, 72%; P=.20). Conclusions This real-world pragmatic observational comparison under routine conditions demonstrates that reorganizing outpatient care for patients with type 1 diabetes into a flexible digital model, DigiDiaS care, did not result in statistically significant between-group differences in health outcomes, including self-management, glycemic control, and well-being, compared with usual care. Over 80% of participants in DigiDiaS care utilized the digital solution, with patient-initiated asynchronous messaging as the most frequently used feature. International Registered Report Identifier (IRRID) RR2-10.2196/52766