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

NCT00922376 | Completed

• 1 other identifier: 09/0201
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes (Insulin-requiring, Type 1 or Type 2)

Keywords

Diabetes; self- management; glycemic control; telehealth; mhealth

Outcome Measures

Primary Outcomes (1)

• Blood sugar levels (HbA1c)

  Baseline, 3 months, 9 months

Secondary Outcomes (13)

• 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

Study Arms (2)

T+ Intervention

ACTIVE COMPARATOR

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+)

Usual care

NO INTERVENTION

The control group will be receiving the standard care offered by the NHS to patients suffering from diabetes.

Interventions

Mobile phone telehealth application: Think Positive (T+) DEVICE

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.

T+ Intervention

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University College London Hospitals: lead
• University College, London: collaborator
• Department of Health, United Kingdom: collaborator

Study Sites (1)

University College London (UCL)

London, W1W 7EJ, United Kingdom

Location

Related Publications (7)

• 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.

  PMID: 19093357 BACKGROUND

• 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.

  PMID: 16176199 BACKGROUND

• 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.

  PMID: 18373577 BACKGROUND

• 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.

  PMID: 17378871 BACKGROUND

• 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.

  PMID: 18166525 BACKGROUND

• 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.

  PMID: 16884582 BACKGROUND

• 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.

  PMID: 25803226 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: June 16, 2009
• First Posted: June 17, 2009
• Study Start: June 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: April 10, 2012

Record last verified: 2012-04

Locations

GB (1)