Mobile Phone Applications and Quality of Life

NCT01444534 | Completed

• 1 other identifier: Pameijer-2011
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 1 Diabetes

Keywords

mobile phone application; diabetes type 1; self-management; telemedicin

Outcome Measures

Primary Outcomes (1)

• Quality of Life

  3 months

Secondary Outcomes (3)

• HbA1c

  3 months

• usability of the application

  3 months

• Self-monitoring of blood glucose (SMBG)

  3 months

Study Arms (2)

use of the diabetes application

EXPERIMENTAL

Device: Dbees; diabetes mobile phone application

Control arm without app (usual care)

ACTIVE COMPARATOR

Device: control group

Interventions

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.

use of the diabetes application

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.

Control arm without app (usual care)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• previous or actual use of a diabetes application
• pregnant

Sponsors & Collaborators

• Medical Research Foundation, The Netherlands: lead

Study Sites (1)

Isala Clinics

Zwolle, 8025 AB, Netherlands

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Henk J. Bilo, MD/PhD

  Isala clinics, medical research foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ass. professor

Study Record Dates

• First Submitted: September 26, 2011
• First Posted: September 30, 2011
• Study Start: September 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: October 24, 2012

Record last verified: 2012-10

Locations

NL (1)