Assessment of the Clinical Efficacy and Acceptability of Think Positive (T+) in Diabetes Management
- Conditions
- Diabetes (Insulin-requiring, Type 1 or Type 2)
- Registration Number
- NCT00922376
- Lead Sponsor
- University College London Hospitals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 86
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Blood sugar levels (HbA1c) Baseline, 3 months, 9 months
- Secondary Outcome Measures
Name Time Method 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 Quality of life Baseline, 3 months, 9 months Health status Baseline, 3 months, 9 months Illness representations Baseline, 3 months, 9 months User acceptability of T+ 3 months, 9 months Nurses' Perceptions of T+ Baseline, 3 months, 9 months Self efficacy in using T+ 3 months, 9 months Health care utilization baseline, 3 months, 9 months Self management baseline, 3 months, 9 months 2 subscales of the HeiQ questionnaire.
Trial Locations
- Locations (1)
University College London (UCL)
🇬🇧London, United Kingdom