POWER2DM: Predictive model-based decision support for diabetes patient empowerment - Quantification Campaign

Diabetes is a chronic condition that involves the inability of the body to
maintain normoglycemia. A large investment of time and energy is required to
properly manage diabetes. Inadequate self-management (including unhealthy
dietary habits, too little self-measurement of blood glucose (SMBG) and insulin
administration based on food intake, too little exercise and other daily
activities in patients on insulin therapy) usually underlies problems to
maintain glycemic control. Hyperglycemia is an important cause of long-term
macro-and micro-vascular complications in all patients with diabetes mellitus.
And in patients on insulin therapy, (fear of) hypoglycemia has an enormous
impact on quality of life. Thus optimization of self-management is one of the
most important treatment goals in all types of diabetes. In order to reduce the
burden and increase the effectiveness of diabetes self-management patients need
to be supported in their self-management using integrated technologies and
personalized plans for care.

The objective of the POWER2DM project is to develop and evaluate technologies
that assist diabetes patients in their self-management using model based
decision support and dynamic action plans. To this purpose we developed a three
month observational quantification campaign to occur next to the patients*
standard care in which we will use traditional means of data collection with
integrated technologies as data input for new glucose simulation models in
patients with diabetes. The predictive models of diabetes will be evaluated in
their ability to predict specific glucose levels.

Observational study divided into two phases. Phase 1 involves one month of data
collection using mobile health devices to monitor glucose levels, physical
activity/sleep tracking, stress, eating behavior, and insulin and medication
usage. In addition patient reported outcomes of quality of life, diabetes
distress, emotional state and stress will be collected via questionnaire.
Information gathered during this phase will be used to create an initial
patient specific glucose metabolic model. Phase 2 is a follow-up phase of two
weeks occurring in month 3 in order to assess whether the original glucose
metabolic model is still accurate.

There is a limited burden to the patients in this observational study. This
burden includes additional visits compared to usual care, becoming acquainted
with e-health care device and filling out of questionnaires. In addition, blood
samples need to be drawn and (more) frequent self-monitoring of glucose by
finger-pricks is necessary on a number of days and a flash glucose monitoring
device (FreeStyle Libre) should be worn on three occasions. Potential benefits
for patients during this 3-month study are more insight into their glucose
levels and how specific lifestyle activities and behavior impact these glucose
levels.