CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 86 enrolled
Drug / intervention
Mobile phone telehealth application: Think Positive (T+)device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00922376
NCT00922376N/ACompleted

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

University College London Hospitals·interventional·Posted Jun 17, 2009·Updated Apr 10, 2012

In Brief

A clinical study evaluating Mobile phone telehealth application: Think Positive (T+) for Diabetes (Insulin-requiring, Type 1 or Type 2). Completed, enrolled 86 participants across 1 site.

Detailed 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 Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 17, 2009
Enrollment StartJun 1, 2010
Primary CompletionNov 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 17.0 years ago

Interventions

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