Psychosocial outcomes among adults with type 1 diabetes using a tubeless automated insulin delivery system compared with sensor augmented pump therapy: A randomised, parallel-group clinical trial sub-study.
Riveline J, Renard E, et al. • Diabetes, obesity & metabolism • 2026
Use of a tubeless AID system improved psychosocial measures to a greater extent than SAP therapy in adults with type 1 diabetes across health-related quality of life, diabetes impact, sleep quality, and system usability.
Key Findings
Results
Adults using the tubeless Omnipod 5 AID system showed greater improvement in health-related quality of life visual analogue scale scores compared to sensor augmented pump therapy.
Measured using the European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3L) visual analogue scale (VAS)
Difference between intervention and control groups was statistically significant (p = 0.01)
Study was a 13-week multicentre, parallel-group, randomised controlled trial
Adults aged 18-70 years with type 1 diabetes were enrolled with a 2:1 randomisation ratio (intervention:control)
Results
The tubeless AID group showed greater improvement in EQ-5D-3L index score compared to the SAP control group.
The difference in EQ-5D-3L index score improvement was statistically significant (p = 0.002)
This measure captures overall health-related quality of life across five dimensions
Improvement was greater in the intervention group than the control group
Results
The tubeless AID system produced greater improvement in the impact of diabetes on quality of life compared to SAP therapy.
Measured using the DAWN2 Impact of Diabetes Profile (DIDP)
Difference between groups was statistically significant (p = 0.004)
The DIDP assesses the broader impact of diabetes on daily life and wellbeing
Results
Perceived system usability was significantly higher in the tubeless AID group compared to the SAP group.
Measured using the System Usability Scale (SUS)
Difference between groups was highly statistically significant (p < 0.0001)
This represents the largest reported p-value difference among all psychosocial measures assessed
Results
Sleep quality improved significantly more in the tubeless AID group than in the SAP control group.
Measured using the Pittsburgh Sleep Quality Index (PSQI)
Difference between groups was statistically significant (p = 0.03)
Sleep quality is an important psychosocial outcome in diabetes management
Results
INSPIRE scores reflecting perceptions of tubeless AID were high at both baseline and follow-up in the intervention group.
INSPIRE (INsulin Dosing Systems: Perceptions, Ideas, Reflections and Expectations) was only administered to the intervention group
High scores at both timepoints suggest consistently positive perceptions of tubeless AID
INSPIRE assesses perceptions before and experiences after using AID systems
Methods
The study design was a 13-week multicentre, parallel-group, randomised controlled trial with a 2:1 allocation ratio comparing tubeless AID to SAP.
Participants were adults aged 18-70 years with type 1 diabetes
Intervention group used the tubeless Omnipod 5 AID System; control group used sensor augmented pump (SAP) therapy
This psychosocial analysis was conducted as a sub-study of the larger RCT
Multiple validated psychosocial questionnaires were administered at baseline and follow-up
What This Means
This research suggests that for adults with type 1 diabetes, using a tubeless automated insulin delivery (AID) system — one that automatically adjusts insulin doses based on continuous glucose readings — leads to greater improvements in psychological and social wellbeing compared to using a sensor-augmented pump (which monitors glucose but does not automatically adjust insulin). Over 13 weeks, people using the tubeless AID system reported better overall quality of life, less burden from diabetes, better sleep, and found their device easier to use than those using the sensor-augmented pump.
The study used several well-established questionnaires to measure these outcomes, including tools that assess general health-related quality of life, how much diabetes affects daily living, sleep quality, and device usability. All differences between the two groups were statistically significant, meaning the improvements seen in the AID group are unlikely to be due to chance. Notably, people in the AID group also reported positive perceptions of the tubeless system both before and after using it.
This research suggests that the benefits of tubeless AID systems go beyond blood sugar control and extend to meaningful improvements in how people with type 1 diabetes feel day-to-day — including reduced diabetes-related burden and better sleep. These findings add to a growing body of evidence that AID technology may help ease the considerable mental and emotional load of managing type 1 diabetes.
Riveline J, Renard E, Aleppo G, Bode B, Brown S, Castorino K, et al.. (2026). Psychosocial outcomes among adults with type 1 diabetes using a tubeless automated insulin delivery system compared with sensor augmented pump therapy: A randomised, parallel-group clinical trial sub-study.. Diabetes, obesity & metabolism. https://doi.org/10.1111/dom.70416