Self-management in Type 2 Diabetes Patients Using the Few Touch Application

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

EARLY_PHASE1

Total Enrollment

151 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2013-10-31

Brief Summary

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

It is hypothesized that the use of the mobile phone-based self-help system FTA, and with the patients as active players, will improve diabetes self-management reflected by improved glycemic control and lipids, self-care behaviours and lifestyle changes such as improved dietary habits and increased physical activity, compared with usual care. Following this; it is also hypothesized that this will also lead to a reduction in overall risk for diabetes complications (expressed by reduction in e.g., 5 year absolute risk for coronary artery disease as calculated using the Swedish National Diabetes Register's risk calculator) and in the prevalence of the metabolic syndrome (e.g., as defined by the International Diabetes Federation). It also hypothesized that health counselling based on TTM and CBT by a diabetes nurse, and with individualized feedback via sms from the diabetes nurse, may have an important function as a supplement to the self-help system (FTA). In addition, it is hypothesized that the patients' health status and diabetes-related quality of life (HRQL) will improve. The results of this study may show that a commonly used tool like the mobile phone, and also mobile phone together with health counselling, fitted into the patients' daily life, is more effective and cost-effective than standard care.

Detailed Description

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

The purpose of this study is to examine the effectiveness of mobile phone-based lifestyle tools, and health counseling using tailored SMS and individual phone-calls to the patients, for self-management of T2DM. Maintaining daily symptom diaries (described below) by an easy way of self-monitoring appear to offer a valid and reliable way of assessing behaviours. In addition, the patients are able to view their own registrations on the Smartphone, i.e. a programmable mobile phone with a touch sensitive screen. The self-help system, called the "Few Touch application", recently tested on 12 people with T2DM at NST, University Hospital of North Norway (UNN), will form the basis for the patients' mobile interaction system.

Conditions

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

Type 2 Diabetes

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.

Control group

Treatment as usual.

Group Type NO_INTERVENTION

No interventions assigned to this group

Few Touch Application (FTA)

This arm will receive a Smartphone with the diabetes diary application ("the Few Touch application"), a self-help tool that consists of five main elements accessible to the user.

Group Type EXPERIMENTAL

Use of Few Touch Application (FTA)

Intervention Type DEVICE

The users will receive a Smartphone with the diabetes diary application ("the Few Touch application"), a self-help tool that consists of five main elements accessible to the user. The five elements are the food habits registration, blood glucose data management system, physical activity registration, personal goals setting and general information. While blood glucose data is automatically transferred to the phone from the blood glucose meter when the user has performed a measurement, activity data and food habits have to be entered manually by the user.

FTA and health counseling

This arm will additionally receive health counseling based on TTM and CBT by a diabetes nurse with individualized feedback via sms from the diabetes nurse which is based on the patient's initiative (via sms). In addition, the diabetes nurse will call the patients three times during this period and discuss progress.

Group Type EXPERIMENTAL

Use of FTA and health counseling based on TTM and CBT

Intervention Type DEVICE

The users will additionally receive health counseling based on TTM and CBT by a diabetes nurse with individualized feedback via SMS from the diabetes nurse which is based on the patient's initiative (via SMS). In addition, the diabetes nurse will call the patients three times during this period and discuss progress. Both the SMS-messages and the calls will be based on CBT according to the TTM-level. The intervention allows information to be given both in an individualized and tailored manner for each particular patient by the nurse, but also in a general way via SMS. The patients need to understand the relationship between areas such as glucose levels, diet, exercises and medicine, in the context of their own lifestyle needs.

Interventions

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

Use of Few Touch Application (FTA)

The users will receive a Smartphone with the diabetes diary application ("the Few Touch application"), a self-help tool that consists of five main elements accessible to the user. The five elements are the food habits registration, blood glucose data management system, physical activity registration, personal goals setting and general information. While blood glucose data is automatically transferred to the phone from the blood glucose meter when the user has performed a measurement, activity data and food habits have to be entered manually by the user.

Intervention Type DEVICE

Use of FTA and health counseling based on TTM and CBT

The users will additionally receive health counseling based on TTM and CBT by a diabetes nurse with individualized feedback via SMS from the diabetes nurse which is based on the patient's initiative (via SMS). In addition, the diabetes nurse will call the patients three times during this period and discuss progress. Both the SMS-messages and the calls will be based on CBT according to the TTM-level. The intervention allows information to be given both in an individualized and tailored manner for each particular patient by the nurse, but also in a general way via SMS. The patients need to understand the relationship between areas such as glucose levels, diet, exercises and medicine, in the context of their own lifestyle needs.

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Use of Diabetesdagbok Use of Few Touch Application with Health Counseling

Eligibility Criteria

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

Inclusion Criteria

Age \>18; diagnosed T2DM \> 3 months prior to study inclusion; in case the patient is receiving one or more glucose lowering drug (e.g., metformin, sulphonylurea, glinide, α-glucosidase inhibitor, DPP-IV inhibitor, GLP-1 analogue, glitazone, insulin) the treatment should be stabilized (i.e., no change in dosage the last three months prior to inclusion except for insulin treated patients who are allowed ±15% dose adjustment; HbA1c \>7%; capability of understanding and filling in Norwegian questionnaires; be able to use the system provided; be cognitive able to participate.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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

Responsibility Role SPONSOR

Principal Investigators

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

Bjørn Engum, M.Sc. / M.HA

Role: STUDY_CHAIR

Norwegian Centre for Integrated Care and Telemedicine (NST ), University Hospital of North- Norway

Locations

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

Oslo University College

Oslo, Oslo County, Norway

Site Status

Norwegian Centre for Integrated Care and Telemedicine (NST ), University Hospital of North- Norway

Tromsø, Troms, Norway

Site Status

Countries

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

Norway

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

Renewing Health Norway

Identifier Type: -

Identifier Source: org_study_id

Self-management in Type 2 Diabetes Patients Using the Few Touch Application

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Study Design

Study Groups

Control group

Few Touch Application (FTA)

Use of Few Touch Application (FTA)

FTA and health counseling

Use of FTA and health counseling based on TTM and CBT

Interventions

Use of Few Touch Application (FTA)

Use of FTA and health counseling based on TTM and CBT

Other Intervention Names

Eligibility Criteria

Inclusion Criteria

Sponsors

Oslo University College

European Commission

The Research Council of Norway

University Hospital of North Norway

Responsible Party

Principal Investigators

Bjørn Engum, M.Sc. / M.HA

Locations

Oslo University College

Norwegian Centre for Integrated Care and Telemedicine (NST ), University Hospital of North- Norway

Countries

References

Arsand E, Tatara N, Ostengen G, Hartvigsen G. Mobile phone-based self-management tools for type 2 diabetes: the few touch application. J Diabetes Sci Technol. 2010 Mar 1;4(2):328-36. doi: 10.1177/193229681000400213.

Arsand E, Tufano JT, Ralston JD, Hjortdahl P. Designing mobile dietary management support technologies for people with diabetes. J Telemed Telecare. 2008;14(7):329-32. doi: 10.1258/jtt.2008.007001.

Arsand E, Demiris G. User-centered methods for designing patient-centric self-help tools. Inform Health Soc Care. 2008 Sep;33(3):158-69. doi: 10.1080/17538150802457562.

Wangberg SC, Arsand E, Andersson N. Diabetes education via mobile text messaging. J Telemed Telecare. 2006;12 Suppl 1:55-6. doi: 10.1258/135763306777978515.

Gammon D, Arsand E, Walseth OA, Andersson N, Jenssen M, Taylor T. Parent-child interaction using a mobile and wireless system for blood glucose monitoring. J Med Internet Res. 2005 Nov 21;7(5):e57. doi: 10.2196/jmir.7.5.e57.

Torbjornsen A, Ribu L, Ronnevig M, Grottland A, Helseth S. Users' acceptability of a mobile application for persons with type 2 diabetes: a qualitative study. BMC Health Serv Res. 2019 Sep 6;19(1):641. doi: 10.1186/s12913-019-4486-2.

Torbjornsen A, Smastuen MC, Jenum AK, Arsand E, Ribu L. Acceptability of an mHealth App Intervention for Persons With Type 2 Diabetes and its Associations With Initial Self-Management: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2018 May 21;6(5):e125. doi: 10.2196/mhealth.8824.

Other Identifiers

Renewing Health Norway