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

Sponsor

University College London Hospitals (Other)

Overall Status

Completed

CT.gov ID

NCT00922376

Collaborator

University College, London (Other), Department of Health, United Kingdom (Other)

Enrollment

Location

Arms

Duration (Months)

5.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes (Insulin-requiring, Type 1 or Type 2)	Device: Mobile phone telehealth application: Think Positive (T+)	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

86 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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

Study Start Date :

Jun 1, 2010

Actual Primary Completion Date :

Nov 1, 2011

Actual Study Completion Date :

Nov 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

Blood sugar levels (HbA1c) [Baseline, 3 months, 9 months]

Secondary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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