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CompletedNCT00922376T+Updated Apr 10, 2012

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

An interventional study of Mobile phone telehealth application: Think Positive (T+) in Diabetes (Insulin-requiring, Type 1 or Type 2), sponsored by University College London Hospitals. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-04-10.

Sponsored by University College London Hospitals · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
86
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

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

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Keywords

  • Diabetes
  • self- management
  • glycemic control
  • telehealth
  • mhealth
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 86 is close to the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

University College London Hospitals is the lead sponsor of 61 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
86 participants (actual)

Study arms

  • Active comparator
    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.

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

  • No intervention
    Usual care

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

Interventions

  • DeviceMobile 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.

06

What researchers measure

Primary outcomes

  1. Blood sugar levels (HbA1c)

    Time frame: Baseline, 3 months, 9 months

Secondary outcomes

  1. BMI

    Time frame: Baseline, 3 months, 9 months

  2. Number of Hypoglycemic events

    Time frame: Baseline, 3 months, 9 months

  3. Blood pressure

    Time frame: Baseline, 3 months, 9 months

  4. Diabetes self-care

    Time frame: Baseline, 3 months, 9 months

  5. Diabetes self- efficacy

    Time frame: Baseline, 3 months, 9 months

  6. Quality of life

    Time frame: Baseline, 3 months, 9 months

  7. Health status

    Time frame: Baseline, 3 months, 9 months

  8. Illness representations

    Time frame: Baseline, 3 months, 9 months

  9. User acceptability of T+

    Time frame: 3 months, 9 months

  10. Nurses' Perceptions of T+

    Time frame: Baseline, 3 months, 9 months

  11. Self efficacy in using T+

    Time frame: 3 months, 9 months

  12. Health care utilization

    Time frame: baseline, 3 months, 9 months

  13. Self management

    2 subscales of the HeiQ questionnaire.

    Time frame: baseline, 3 months, 9 months

07

Study locations

1 site
  • University College London (UCL)
    London, W1W 7EJ, United Kingdom
08

References and documents

Publications

  • Blake H. Mobile phone technology in chronic disease management. Nurs Stand. 2008 Nov 26-Dec 2;23(12):43-6. doi: 10.7748/ns2008.11.23.12.43.c6728. PubMed 19093357 ↗
  • Farmer A, Gibson OJ, Tarassenko L, Neil A. A systematic review of telemedicine interventions to support blood glucose self-monitoring in diabetes. Diabet Med. 2005 Oct;22(10):1372-8. doi: 10.1111/j.1464-5491.2005.01627.x. PubMed 16176199 ↗
  • Faridi Z, Liberti L, Shuval K, Northrup V, Ali A, Katz DL. Evaluating the impact of mobile telephone technology on type 2 diabetic patients' self-management: the NICHE pilot study. J Eval Clin Pract. 2008 Jun;14(3):465-9. doi: 10.1111/j.1365-2753.2007.00881.x. Epub 2008 Mar 24. PubMed 18373577 ↗
  • Jaana M, Pare G. Home telemonitoring of patients with diabetes: a systematic assessment of observed effects. J Eval Clin Pract. 2007 Apr;13(2):242-53. doi: 10.1111/j.1365-2753.2006.00686.x. PubMed 17378871 ↗
  • Kollmann A, Riedl M, Kastner P, Schreier G, Ludvik B. Feasibility of a mobile phone-based data service for functional insulin treatment of type 1 diabetes mellitus patients. J Med Internet Res. 2007 Dec 31;9(5):e36. doi: 10.2196/jmir.9.5.e36. PubMed 18166525 ↗
  • Wangberg SC, Arsand E, Andersson N. Diabetes education via mobile text messaging. J Telemed Telecare. 2006;12 Suppl 1:55-6. doi: 10.1258/135763306777978515. PubMed 16884582 ↗
  • 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. PubMed 25803226 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 10, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00922376
Lead sponsor
University College London Hospitals
Collaborators
University College, London, Department of Health, United Kingdom
Responsible party
Justine Baron (Researcher, University College, London) — Principal investigator
First posted
Jun 17, 2009
Start date
Jun 2010
Primary completion
Nov 2011
Completion
Nov 2011
Last update
Apr 10, 2012

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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