MedDataX Logo

Mobile Phone Applications and Quality of Life

NCT ID: NCT01444534

Last Updated: 2012-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2012-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type 1 Diabetes

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

mobile phone application diabetes type 1 self-management telemedicin

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

use of the diabetes application

Group Type EXPERIMENTAL

Dbees; diabetes mobile phone application

Intervention Type 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 arm without app (usual care)

Group Type ACTIVE_COMPARATOR

control group

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dbees; diabetes mobile phone application

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.

Intervention Type DEVICE

control group

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Medical Research Foundation, The Netherlands

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Nanne Kleefstra

ass. professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Henk J. Bilo, MD/PhD

Role: PRINCIPAL_INVESTIGATOR

Isala clinics, medical research foundation

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Isala Clinics

Zwolle, , Netherlands

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Netherlands

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Pameijer-2011

Identifier Type: -

Identifier Source: org_study_id