Skip to main content
OpenTrials
Completed

NCT Number: NCT00922376

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University College London (UCL)

London, W1W 7EJ, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Blood sugar levels (HbA1c)

    Time frame: Baseline, 3 months, 9 months

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

University College London Hospitals

Other

Collaborators

  • Department of Health, United Kingdom
  • University College, London

Registry information

Official study title

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

Acronym: T+

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jun 17, 2009
Registry last updated
Apr 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.