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

University College London Hospitals NHS Foundation Trust (UCLH)

Status: Completed

Conditions: Diabetes (Insulin-requiring, Type 1 or Type 2)

Treatments: Device: Mobile phone telehealth application: Think Positive (T+)

Study type: Interventional

Funder types: Other

Identifiers

NCT00922376

09/0201

Details and patient eligibility

About

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.

Enrollment: 86 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

86 participants in 2 patient groups

T+ Intervention

Active Comparator group

Description:

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.

Treatment:

Device: Mobile phone telehealth application: Think Positive (T+)

Usual care

No Intervention group

Description:

The control group will be receiving the standard care offered by the NHS to patients suffering from diabetes.