JMIR Publications

ABSTRACT

Background:

A new application, the Sukaribit, was designed to enable contact between the caregiver and the patient with the intention to improve self-care and glycaemic control (HbA1c).

Objective:

This study investigated the feasibility of the study methodology and the intervention in preparation for a larger effectiveness study.

Methods:

Adults with type 2-diabetes were recruited in this randomized controlled pilot trial with a multi method design. The intervention group (n=28) tried Sukaribit for two months. They were encouraged to report blood glucose levels and medicines and they received feedback from a physician. The control group (n=31) received standard care. Both groups were evaluated with pre- and post-measurements of glycaemic control (HbA1c), diabetes distress, physical activity and self-care. The feasibility was evaluated against five progression criteria regarding recruitment, study methods and active participation.

Results:

Of the five progression criteria only two were met or partly met. The recruitment process exceeded the expectations and data collection worked well for self-report data but not for HbA1c measured with a home-testing kit. The participants were less active than anticipated and the effect sizes were small. Only blood glucose tests per day was positively affected by the intervention indicating 0.6 more tests per day in the intervention group.

Conclusions:

Recruitment of participants to a future fully powered study may work with minor adjustments. The collection of HbA1c using home-testing constituted a major problem and an alternative strategy is warranted. Finally, the application was not used as intended. In order to proceed with a larger study, the application and study procedures needs improvement.