Assessment of the Clinical Efficacy and Acceptability of the Think Positive (T+) Diabetes Management System in Insulin Requiring Diabetes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 86
- Locations
- 2
- Primary Endpoint
- Blood sugar levels (HbA1c)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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
Outcomes
Primary Outcomes
Blood sugar levels (HbA1c)
Time Frame: Baseline, 3 months, 9 months
Secondary Outcomes
- 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)
Investigators
Justine Baron
Researcher
University College, London