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NCT Number: NCT01444534

Mobile Phone Applications and Quality of Life

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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Isala Clinics

Zwolle, 8025 AB, Netherlands

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • diabetes type 1
  • >18 years old
  • patient having a smartphone, who are familiar with its use

Exclusion criteria

  • previous or actual use of a diabetes application
  • pregnant

Treatment and study plan

Dbees; diabetes mobile phone application

Device

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.

Control group

Device

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.

Primary outcomes

  1. Quality of Life

    Time frame: 3 months

Secondary outcomes

  1. HbA1c

    Time frame: 3 months

  2. usability of the application

    Time frame: 3 months

    questionnaire System Usability Scale (SUS)

  3. Self-monitoring of blood glucose (SMBG)

    Time frame: 3 months

    frequency of blood glucose monitoring

Sponsors and collaborators

Lead sponsor

Medical Research Foundation, The Netherlands

Other

Registry information

Official study title

Influence of a Mobile Phone Application on Quality of Life of Patients With Type 1 Diabetes Mellitus: a Randomized Controlled Trial

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Sep 30, 2011
Registry last updated
Oct 24, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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