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

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ClinicalTrials.gov Identifier: NCT00922376
Recruitment Status : Completed
First Posted : June 17, 2009
Last Update Posted : April 10, 2012
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Diabetes (Insulin-requiring, Type 1 or Type 2) Device: Mobile phone telehealth application: Think Positive (T+)

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessment of the Clinical Efficacy and Acceptability of the Think Positive (T+) Diabetes Management System in Insulin Requiring Diabetes
Study Start Date : June 2010
Primary Completion Date : November 2011
Study Completion Date : November 2011
Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :
  1. Blood sugar levels (HbA1c) [ Time Frame: Baseline, 3 months, 9 months ]

Secondary Outcome Measures :
  1. BMI [ Time Frame: Baseline, 3 months, 9 months ]
  2. Number of Hypoglycemic events [ Time Frame: Baseline, 3 months, 9 months ]
  3. Blood pressure [ Time Frame: Baseline, 3 months, 9 months ]
  4. Diabetes self-care [ Time Frame: Baseline, 3 months, 9 months ]
  5. Diabetes self- efficacy [ Time Frame: Baseline, 3 months, 9 months ]
  6. Quality of life [ Time Frame: Baseline, 3 months, 9 months ]
  7. Health status [ Time Frame: Baseline, 3 months, 9 months ]
  8. Illness representations [ Time Frame: Baseline, 3 months, 9 months ]
  9. User acceptability of T+ [ Time Frame: 3 months, 9 months ]
  10. Nurses' Perceptions of T+ [ Time Frame: Baseline, 3 months, 9 months ]
  11. Self efficacy in using T+ [ Time Frame: 3 months, 9 months ]
  12. Health care utilization [ Time Frame: baseline, 3 months, 9 months ]
  13. Self management [ Time Frame: baseline, 3 months, 9 months ]
    2 subscales of the HeiQ questionnaire.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00922376

United Kingdom
University College London (UCL)
London, United Kingdom, W1W 7EJ
Sponsors and Collaborators
University College London Hospitals
University College, London
Department of Health, United Kingdom
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Justine Baron, Researcher, University College, London
ClinicalTrials.gov Identifier: NCT00922376     History of Changes
Other Study ID Numbers: 09/0201
First Posted: June 17, 2009    Key Record Dates
Last Update Posted: April 10, 2012
Last Verified: April 2012

Keywords provided by Justine Baron, University College, London:
self- management
glycemic control

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases