Enhancing type 2 diabetes treatment through digital plans of care – a randomized controlled trial: evaluation of change in patient reported outcome measures

ABSTRACT

Background

We investigated how a personalized care-planning software and linked mobile-app may aid people to self-manage their type 2 diabetes (T2D) more effectively.

Research Design and Methods

People with T2D and glycated hemoglobin (HbA1c) greater than 58 mmol/mol (7.5%) were randomized to either an intervention group receiving a personalized care plan, or the control group receiving usual care. Quality of life (QoL) was measured for both groups using validated questionnaires and one-on-one interviews with a subset of 12 participants from each group.

Results

QoL for the active treatment group increased, by their EQ −5D-5 L score increasing on average by 0.046, whereas it decreased for the control group on average by 0.009. The EQ Visual Analogue Score (VAS) of the intervention group also increased by 8.2%, whereas the control group had a reduction in EQ VAS score of 2.8% (p = 0.008 for difference).

Conclusion

In this prospective RCT, the findings point to how the provision of personalized care plans can result in an improvement in individuals’ self-rated QoL. This may lead to longer term health benefits.

KEYWORDS:

• App
• care planning
• digital
• self management
• type 2 diabetes

Competing interests

No author has any conflict of interest. The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Authorship

All authors:

1. Made a significant contribution to the work reported, whether that’s in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas.

2. Have drafted or written, or substantially revised or critically reviewed the article.

3. Have agreed on the journal to which the article will be submitted.

4. Reviewed and agreed on all versions of the article before submission, during revision, the final version accepted for publication, and any significant changes introduced at the proofing stage.

5. Agree to take responsibility and be accountable for the contents of the article and to share responsibility to resolve any questions raised about the accuracy or integrity of the published work.

Specifically:

AHH

Ethical permission was granted by the West Midlands REC (IRAS ID 272,569). Participatory consent was obtained from all patients.

Additional information

Funding

The research project was funded by Innovate UK.