Assessment of the Clinical Efficacy and Acceptability of Think Positive (T+) in Diabetes Management (T+)

Assessment of the Clinical Efficacy and Acceptability of the Think Positive (T+) Diabetes Management System in Insulin Requiring Diabetes

New telemedicine systems have been designed to assist people suffering from diabetes in the management of their chronic disease. More recently the focus has been moving to portable systems equipped with Bluetooth. This study consists of evaluating an application called the Think Positive (T+) diabetes management software. It is a randomized controlled trial designed to compare, over a nine month period, a group of patients receiving usual care with a group of patients using the T+ system. The objectives of the study are to investigate the extent to which this telemedicine application helps patients control their blood sugar levels (HbA1c), as well as the extent to which its users consider it to be acceptable. The impact of its use on factors such as diabetes self-care, health status, quality of life, self-confidence in diabetes management, fear of hypoglycemia and illness representations will also be examined. Because of the supplementary real-time support and feedback that T+ offers, its use should lead to better outcomes in diabetes management than usual care does.

Study Overview

• Status: Completed
• Conditions: Diabetes (Insulin-requiring, Type 1 or Type 2)
• Intervention / Treatment: Device: Mobile phone telehealth application: Think Positive (T+)

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, W1W 7EJ
    • University College London (UCL)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Type 1 and type 2 diabetes patients
• Insulin requiring patients
• Sufficiently fluent in english
• HbA1c > 7.5
• Last visit with Diabetes Specialist Nurse (DSN) < 12 months

Exclusion Criteria:

• Psychiatric disorders
• Poor vision or/and lack of manual dexterity
• Prior use of T+
• Participation in another ongoing trial
• Patients with antenatal/gestational
• Patients who are in transition between the children services and adult services Insulin pump users

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: T+ Intervention; The intervention group patients will use the T+ telemedicine application whilst completing repeated measures aiming to compare them to a control group receiving standard care.	Device: Mobile phone telehealth application: Think Positive (T+); T+ consists of the Glucometer paired with a cradle that transmits via Bluetooth blood glucose results to a mobile phone. Data is stored and sent to a secure website. The website can be accessed by the patient as well as by health care providers (HCP). HCP can discuss data on the phone and make recommendations via text messages to patients. Visual feedback (graphs and statistics) illustrating recent blood sugar levels patterns is automatically and immediately sent to the patient when data is transferred from the T+ phone.
No Intervention: Usual care; The control group will be receiving the standard care offered by the NHS to patients suffering from diabetes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Blood sugar levels (HbA1c)	Baseline, 3 months, 9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BMI		Baseline, 3 months, 9 months
Number of Hypoglycemic events		Baseline, 3 months, 9 months
Blood pressure		Baseline, 3 months, 9 months
Diabetes self-care		Baseline, 3 months, 9 months
Diabetes self- efficacy		Baseline, 3 months, 9 months
Quality of life		Baseline, 3 months, 9 months
Health status		Baseline, 3 months, 9 months
Illness representations		Baseline, 3 months, 9 months
User acceptability of T+		3 months, 9 months
Nurses' Perceptions of T+		Baseline, 3 months, 9 months
Self efficacy in using T+		3 months, 9 months
Health care utilization		baseline, 3 months, 9 months
Self management	2 subscales of the HeiQ questionnaire.	baseline, 3 months, 9 months

Collaborators and Investigators

• Sponsor: University College London Hospitals
• Collaborators: University College, London; Department of Health, United Kingdom

Publications and helpful links

General Publications

• 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.
• Blake H. Mobile phone technology in chronic disease management. Nurs Stand. 2008 Nov 26-Dec 2;23(12):43-6. doi: 10.7748/ns2008.11.23.12.43.c6728.
• Farmer A, Gibson OJ, Tarassenko L, Neil A. A systematic review of telemedicine interventions to support blood glucose self-monitoring in diabetes. Diabet Med. 2005 Oct;22(10):1372-8. doi: 10.1111/j.1464-5491.2005.01627.x.
• Faridi Z, Liberti L, Shuval K, Northrup V, Ali A, Katz DL. Evaluating the impact of mobile telephone technology on type 2 diabetic patients' self-management: the NICHE pilot study. J Eval Clin Pract. 2008 Jun;14(3):465-9. doi: 10.1111/j.1365-2753.2007.00881.x. Epub 2008 Mar 24.
• Jaana M, Pare G. Home telemonitoring of patients with diabetes: a systematic assessment of observed effects. J Eval Clin Pract. 2007 Apr;13(2):242-53. doi: 10.1111/j.1365-2753.2006.00686.x.
• Kollmann A, Riedl M, Kastner P, Schreier G, Ludvik B. Feasibility of a mobile phone-based data service for functional insulin treatment of type 1 diabetes mellitus patients. J Med Internet Res. 2007 Dec 31;9(5):e36. doi: 10.2196/jmir.9.5.e36.
• Baron J, Hirani S, Newman S. A mobile telehealth intervention for adults with insulin-requiring diabetes: early results of a mixed-methods randomized controlled trial. JMIR Res Protoc. 2015 Feb 26;4(1):e27. doi: 10.2196/resprot.4035.

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): November 1, 2011

Study Registration Dates

• First Submitted: June 16, 2009
• First Submitted That Met QC Criteria: June 16, 2009
• First Posted (Estimate): June 17, 2009

Study Record Updates

• Last Update Posted (Estimate): April 10, 2012
• Last Update Submitted That Met QC Criteria: April 9, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Keywords: Diabetes; mhealth; telehealth; glycemic control; self- management
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: 09/0201