Accepted for/Published in: Journal of Medical Internet Research
Date Submitted: Mar 6, 2026
Date Accepted: Jun 4, 2026
Digital outpatient care for patients with type 1 diabetes (DigiDiaS): a pragmatic observational pre-post study
ABSTRACT
Background:
Patient reported outcomes in digital health solutions can offer patients with type 1 diabetes an opportunity to voice their needs in outpatient care, thereby enabling healthcare professionals to tailor support to individual needs. However, there is limited evidence on the long term health impact of such digital solutions and on how they are integrated and utilised in routine practice outside controlled settings.
Objective:
To evaluate the effect of a flexible digital supplement to outpatient care for type 1 diabetes (DigiDiaS) compared with usual care over 1-year, with self-management as the primary outcome and glycaemic 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 and chose either the digital mHealth-based outpatient care model ‘DigiDiaS’ care or usual care. DigiDiaS care is delivered via a smartphone app and includes a messaging service, PRO-based pre-consultation questionnaires, video, telephone, and in-person consultations, and an individually tailored information section. Outcome data comprised self‑reported measures, and clinical data extracted from electronic medical records, the national diabetes registry and the digital platform. Data were collected at baseline and at the one‑year follow‑up. Change in self‑management (PAM‑13; primary outcome), and the secondary outcomes well‑being (WHO‑5) and glycaemic control (HbA1c) were analysed using a generalized linear model (GLM). Utilisation of the digital solution and healthcare services was also explored.
Results:
We included 237 patients, with 185 (78%) opting for DigiDiaS care and 52 (22%) for usual care. Most participants (n= 145; 81%) in the DigiDiaS care group used the digital solution. The messaging service was the most utilised 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 = .718), glycaemic control (HbA1c mean difference -2.1, 95% CI [-6.6 to 2.4]; P = .362), or well-being (mean difference 1.9, 95% CI [-3.1 to 6.9]; P = .462). Healthcare utilisation did not differ between the groups, including participation in one or more individual consultations during the 1-year follow-up (DigiDiaS care n= 159 (89%); usual care n=42 (84%); P = .303), or appointment cancellations (DigiDiaS care n= 64 (70%); usual care n=13 (72%); P = .200).
Conclusions:
This study demonstrates that reorganising outpatient care for patients with type 1 diabetes into a flexible digital model, DigiDiaS care, did not result in statistically significant changes in health outcomes, including self-management, glycaemic control, and well-being, compared with usual care. Over 80% of participants in DigiDiaS care utilised the digital solution, with patient-initiated asynchronous messaging as the most frequently used feature.
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