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Clinical Trials/NCT00922376
NCT00922376
Completed
Not Applicable

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

University College London Hospitals1 site in 1 country86 target enrollmentJune 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetes (Insulin-requiring, Type 1 or Type 2)
Sponsor
University College London Hospitals
Enrollment
86
Locations
1
Primary Endpoint
Blood sugar levels (HbA1c)
Status
Completed
Last Updated
14 years ago

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.

Registry
clinicaltrials.gov
Start Date
June 2010
End Date
November 2011
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University College London Hospitals
Responsible Party
Principal Investigator
Principal Investigator

Justine Baron

Researcher

University College, London

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

Outcomes

Primary Outcomes

Blood sugar levels (HbA1c)

Time Frame: Baseline, 3 months, 9 months

Secondary Outcomes

  • 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)

Study Sites (1)

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