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

This study has been completed.
Sponsor:
Collaborators:
University College, London
Department of Health, United Kingdom
Information provided by (Responsible Party):
Justine Baron, University College, London
ClinicalTrials.gov Identifier:
NCT00922376
First received: June 16, 2009
Last updated: April 9, 2012
Last verified: April 2012
History of Changes
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University College London Hospitals:

Primary Outcome Measures:
  • Blood sugar levels (HbA1c) [ Time Frame: Baseline, 3 months, 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • BMI [ Time Frame: Baseline, 3 months, 9 months ] [ Designated as safety issue: No ]
  • Number of Hypoglycemic events [ Time Frame: Baseline, 3 months, 9 months ] [ Designated as safety issue: No ]
  • Blood pressure [ Time Frame: Baseline, 3 months, 9 months ] [ Designated as safety issue: No ]
  • Diabetes self-care [ Time Frame: Baseline, 3 months, 9 months ] [ Designated as safety issue: No ]
  • Diabetes self- efficacy [ Time Frame: Baseline, 3 months, 9 months ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: Baseline, 3 months, 9 months ] [ Designated as safety issue: No ]
  • Health status [ Time Frame: Baseline, 3 months, 9 months ] [ Designated as safety issue: No ]
  • Illness representations [ Time Frame: Baseline, 3 months, 9 months ] [ Designated as safety issue: No ]
  • User acceptability of T+ [ Time Frame: 3 months, 9 months ] [ Designated as safety issue: No ]
  • Nurses' Perceptions of T+ [ Time Frame: Baseline, 3 months, 9 months ] [ Designated as safety issue: No ]
  • Self efficacy in using T+ [ Time Frame: 3 months, 9 months ] [ Designated as safety issue: No ]
  • Health care utilization [ Time Frame: baseline, 3 months, 9 months ] [ Designated as safety issue: No ]
  • Self management [ Time Frame: baseline, 3 months, 9 months ] [ Designated as safety issue: No ]
    2 subscales of the HeiQ questionnaire.


Enrollment: 86
Study Start Date: June 2010
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00922376

Locations
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

Additional Information:
T+ medical disease management systems  This link exits the ClinicalTrials.gov site

Publications:
Blake H (2008), Mobile phone technology in chronic disease management, Nursing Standard, vol. 23(12), p.43- 46.

Responsible Party: Justine Baron, Researcher, University College, London
ClinicalTrials.gov Identifier: NCT00922376     History of Changes
Other Study ID Numbers: 09/0201
Study First Received: June 16, 2009
Last Updated: April 9, 2012
Health Authority: United Kingdom: Department of Health

Keywords provided by University College London Hospitals:
Diabetes
self- management
glycemic control
telehealth
mhealth

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

ClinicalTrials.gov processed this record on May 23, 2013