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

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.

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

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

Intervention / Treatment
-----------------
* Device: Mobile phone telehealth application: Think Positive (T+)


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: T+ Intervention<br>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+)<br>* 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.<br>|
| No Intervention: Usual care<br>The control group will be receiving the standard care offered by the NHS to patients suffering from diabetes. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood sugar levels (HbA1c) |  | Baseline, 3 months, 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 2 subscales of the HeiQ questionnaire. | baseline, 3 months, 9 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes, self- management, glycemic control, telehealth, mhealth