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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2011-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Mobile phone telehealth application: Think Positive (T+)

Intervention Type DEVICE

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.

Usual care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No