Clinical trial NCT00922376: Assessment of the Clinical Efficacy and Acceptability of Think Positive (T+) in Diabetes Management
Official title: Assessment of the Clinical Efficacy and Acceptability of the Think Positive (T+) Diabetes Management System in Insulin Requiring Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes (Insulin-requiring, Type 1 or Type 2)
Keywords: Diabetes
self- management
glycemic control
telehealth
mhealth
Lead sponsor: University College London Hospitals
Sponsor class: OTHER
Collaborators: name: University College, London
name: Department of Health, United Kingdom
First posted: 2009-06-17
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Blood sugar levels (HbA1c)
timeFrame: Baseline, 3 months, 9 months
Secondary outcomes:
measure: BMI
timeFrame: Baseline, 3 months, 9 months
measure: Number of Hypoglycemic events
timeFrame: Baseline, 3 months, 9 months
measure: Blood pressure
timeFrame: Baseline, 3 months, 9 months
measure: Diabetes self-care
timeFrame: Baseline, 3 months, 9 months
measure: Diabetes self- efficacy
timeFrame: Baseline, 3 months, 9 months
measure: Quality of life
timeFrame: Baseline, 3 months, 9 months
measure: Health status
timeFrame: Baseline, 3 months, 9 months
measure: Illness representations
timeFrame: Baseline, 3 months, 9 months
measure: User acceptability of T+
timeFrame: 3 months, 9 months
measure: Nurses' Perceptions of T+
timeFrame: Baseline, 3 months, 9 months
measure: Self efficacy in using T+
timeFrame: 3 months, 9 months
measure: Health care utilization
timeFrame: baseline, 3 months, 9 months
measure: Self management
timeFrame: baseline, 3 months, 9 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: University College London (UCL)
Study officials:
References:
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citation: Baron J, Hirani S, Newman S. A mobile telehealth intervention for adults with insulin-requiring diabetes: early results of a mixed-methods randomized controlled trial. JMIR Res Protoc. 2015 Feb 26;4(1):e27. doi: 10.2196/resprot.4035.