- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00922376
Assessment of the Clinical Efficacy and Acceptability of Think Positive (T+) in Diabetes Management (T+)
April 9, 2012 updated by: Justine Baron, University College London Hospitals
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
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
86
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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London, United Kingdom, W1W 7EJ
- University College London (UCL)
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
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.
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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.
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No Intervention: Usual care
The control group will be receiving the standard care offered by the NHS to patients suffering from diabetes.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Blood sugar levels (HbA1c)
Time Frame: Baseline, 3 months, 9 months
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Baseline, 3 months, 9 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
BMI
Time Frame: Baseline, 3 months, 9 months
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Baseline, 3 months, 9 months
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Number of Hypoglycemic events
Time Frame: Baseline, 3 months, 9 months
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Baseline, 3 months, 9 months
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Blood pressure
Time Frame: Baseline, 3 months, 9 months
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Baseline, 3 months, 9 months
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Diabetes self-care
Time Frame: Baseline, 3 months, 9 months
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Baseline, 3 months, 9 months
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Diabetes self- efficacy
Time Frame: Baseline, 3 months, 9 months
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Baseline, 3 months, 9 months
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Quality of life
Time Frame: Baseline, 3 months, 9 months
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Baseline, 3 months, 9 months
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Health status
Time Frame: Baseline, 3 months, 9 months
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Baseline, 3 months, 9 months
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Illness representations
Time Frame: Baseline, 3 months, 9 months
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Baseline, 3 months, 9 months
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User acceptability of T+
Time Frame: 3 months, 9 months
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3 months, 9 months
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Nurses' Perceptions of T+
Time Frame: Baseline, 3 months, 9 months
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Baseline, 3 months, 9 months
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Self efficacy in using T+
Time Frame: 3 months, 9 months
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3 months, 9 months
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Health care utilization
Time Frame: baseline, 3 months, 9 months
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baseline, 3 months, 9 months
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Self management
Time Frame: baseline, 3 months, 9 months
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2 subscales of the HeiQ questionnaire.
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baseline, 3 months, 9 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09/0201
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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