Mobile Phone Applications and Quality of Life
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The use of smartphones has increased substantially in recent years. Apart from making phone
      calls and sending short messages, these smartphones can also function as a computer on which
      one can download computer programs (the so-called applications). Health applications are
      increasingly developed and may be a new tool for education of patients and communication
      between healthcare providers and their patients, possibly contributing to a better care for
      patients with chronic diseases such as diabetes.

      Since the number of patients with diabetes mellitus and the number of people having a
      smartphone are rising, it is investigated whether applications on smartphones may be used to
      support lifestyle changes and self-monitoring of bloodglucose control, possibly leading to an
      improved glycaemic regulation in the group of patients with diabetes mellitus.

      Large randomized controlled trials have shown that a stable glycaemic regulation is important
      to reduce morbidity and mortality and to improve quality of life (QOL). Self-monitoring of
      blood glucose is an important tool to realize an optimal glycaemic regulation in patients
      with type 1 diabetes mellitus (T1DM). Apart from a good glycaemic control, QOL is essential
      in diabetic patients. A reduced QOL is associated with progression of the disease, worse
      intake of medication and an increased mortality in patients with T1DM and diabetes mellitus
      type 2.

      The increasing costs associated with the rising number of diabetic patients makes that
      research investigating cheaper alternatives in the care for patients with diabetes are
      needed. The switch from a written logbook to an electronic logbook may simplify the care for
      diabetes patients. By means of an application all variables (food intake, physical exercise,
      glucose day curves, insulin units, reminders to take medication) are integrated in one
      program. But whether this digitalisation also improves QOL of the patient is still unclear.

      Therefore the aim of this study is to evaluate the effect of a diabetes application on the
      (QOL) for type 1 diabetic patients.
    

Detailed description: 
      Participants in both groups were invited to participate after their periodical visit to the
      doctor or the hospital-based nurse specialised in the care for diabetes patients. All
      participants in this study were adults with T1DM having a smartphone.

      All participants will complete the The Short Form Health Survey (SF-36) and the Problem Areas
      In Diabetes questionnaire (PAID) at baseline and after three months of follow-up. Baseline
      information, including socio demographic information (age, sex, highest level of school
      education), and clinical characteristics (diabetes duration, insulin therapy and presence and
      severity of diabetes complications) will be collected in a database. Moreover parameters such
      as blood pressure, body weight, HbA1c and lipid profile will be added.

      Sample size calculation

      The study was powered to detect a between-group mean difference of 10 points in the The Short
      Form Health Survey (SF-36) questionnaire after 3 months. With a power of 80%, alpha 0.05, the
      total sample size of the study should be 62 patients (31 in each group).
    

Intervention name(s): Dbees; diabetes mobile phone application; control group
Intervention type(s): Device; Device
Intervention description(s): Participants randomized to the intervention group (G2) were asked to stop using their paper logbook and start using an electronic logbook on their computer and mobile phone using an application of Dbees. The Dbees software enables the mobile phone to be used as a small computer to record the blood glucose values, dose of insulin injection, daily carbohydrate intake, amount of physical activity, and blood pressure.; Participants in the control group (G1) continued using their paper logbook (usual care) and had no electronic logbook. Patients in the control group were requested not to use another mobile phone application instead of or besides their paper logbook.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: mobile phone application; diabetes type 1; self-management; telemedicin