Clinical Validation of DiaFocus

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We can share that the DiaFocus mobile health system for type 2 diabetes (T2D) [1] has now been clinically validated in routine care by clinicians at Steno Diabetes Center Copenhagen (SDCC) [2].

In a 6-month outpatient pilot at SDCC, DiaFocus supported an integrated personalized diabetes management (iPDM) workflow [3-4] with a patient app and a clinician web portal, connected via the CARP secure backend. The study demonstrates that DiaFocus is feasible and acceptable in clinical practice and supports shared decision-making around patient-chosen focus areas. 

What the study tested

  • Design & setting: Single-arm, prospective 6-month cohort in routine outpatient care at SDCC. Participants attended 3 clinic visits (baseline, 3 months, 6 months) aligned with the iPDM cycle. 
  • Participants: 17 adults with T2D (15 completed). Median age 68 years; median HbA1c 59 mmol/mol. Inclusion required Danish language and a smartphone (iOS 13+ or Android 8.0+). 
  • Measures: Clinical outcomes (HbA1c, weight, DDS, PCDS, DTSQs+c) and clinical feasibility via retention, usage, interviews, and the CACHET Unified Method for Assessment of Clinical Feasibility (CUMACF). 

Key findings:

  • Participants rated DiaFocus highly on usability and usefulness (CUMACF: 90% very favorable on ease of use/learning; 80% agreed/strongly agreed it was useful). 
  • The most common patient-selected focus areas were blood glucose (59%) and exercise (53%), with sleep and mood also used. 
  • However, as a feasibility pilot, no statistically significant changes in clinical outcomes were observed over 6 months — underscoring the need for longer follow-up and continued product optimization. 

Read the open-access paper in JMIR Diabetes, “Assessing the Clinical Feasibility of the DiaFocus System for Integrated Personalized Management of Type 2 Diabetes: 6-Month Pilot Cohort Study” [2].

How DiaFocus has been implemented using the CARP stack

DiaFocus was engineered on CARP to deliver a flexible, secure, and research-grade digital health stack:

  • Patient app: The DiaFocus app was built using several CARP components, including CARP Mobile Sensing and the Research Package. It collects (1) patient-reported measures (eg, blood glucose entries, smoking, alcohol), (2) standardized questionnaires (eg, WHO-5), and (3) passive phone sensor data (eg, steps). Questionnaires are adaptively triggered based on responses (eg, adding sleep, anxiety, depression when relevant). 
  • Shared decision-making via “focus areas”: At each clinic visit, the person with diabetes and clinician agree on one or more focus areas (eg, exercise, diet, smoking), which the app then helps track between visits. Data are summarized at the next visit to guide the conversation and reset goals together. 
  • Clinician web portal: Aggregates app and sensor data into readable reports for the consultation, anchoring the iPDM cycle inside usual care. 
  • Secure backend: The CARP Web Services hosted at DTU Computerome, enabling privacy-preserving data management across settings — a core tenet of CARP deployments. 

Building on prior evidence

DiaFocus extends earlier work on the iPDM framework [3] and our initial 6-week technical feasibility pilot [1], which found the approach useful and usable and informed refinements ahead of this clinical study. 

What we learned from deploying in routine care

  • People value agency. The ability to pick personal focus areas made the system feel relevant and actionable between visits. 
  • Keep it simple & stable. Usability was rated highly, yet real-world deployment surfaced the usual app stability and functionality issues to address next. 
  • Feasibility first. A 6-month single-arm design is ideal to prove fit in clinic; demonstrating clinical effectiveness will require larger and longer trials — now under consideration. 

Reference

  1. Bardram, J. E., Cramer-Petersen, C., Maxhuni, A., Christensen, M. V., Bækgaard, P., Persson, D. R., … & Jones, A. (2022). DiaFocus: A Personal Health Technology for Adaptive Assessment in Long-Term Management of Type 2 Diabetes. ACM Transactions on Computing for Healthcare.
  2. Lind, N., Bækgaard, P., Bardram, J. E., Cramer-Petersen, C., Nørgaard, K., & Christensen, M. B. (2025). Assessing the Clinical Feasibility of the DiaFocus System for Integrated Personalized Management of Type 2 Diabetes: 6-Month Pilot Cohort Study. JMIR diabetes, 10(1), e63894.
  3. Ceriello, A., Barkai, L., Christiansen, J. S., Czupryniak, L., Gomis, R., Harno, K., … & Wens, J. (2012). Diabetes as a case study of chronic disease management with a personalized approach: the role of a structured feedback loop. Diabetes research and clinical practice, 98(1), 5-10.
  4. Jones, A., Bardram, J. E., Bækgaard, P., Cramer-Petersen, C. L., Skinner, T., Vrangbæk, K., … & Kownatka, D. (2021). Integrated personalized diabetes management goes Europe: a multi-disciplinary approach to innovating type 2 diabetes care in Europe. Primary care diabetes, 15(2), 360-364.

Acknowledgments

This research is part of the iPDM-GO project [4], which received funding from EIT Health. EIT Health is supported by the European Institute of Innovation and Technology (EIT), a body of the European Union that receives support from the European Union’s Horizon Europe research and innovation program. This work was also supported by the Copenhagen Center for Health Technology, which received financial support from the City of Copenhagen, the Capital Region of Denmark, the University of Copenhagen, and the Technical University of Denmark.