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| Name | Class |
|---|---|
| University College, London | OTHER |
| Department of Health, United Kingdom | OTHER_GOV |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| T+ Intervention | Active Comparator | 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. |
|
| Usual care | No Intervention | The control group will be receiving the standard care offered by the NHS to patients suffering from diabetes. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Blood sugar levels (HbA1c) | Baseline, 3 months, 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| BMI | Baseline, 3 months, 9 months | |
| Number of Hypoglycemic events | Baseline, 3 months, 9 months | |
| Blood pressure |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University College London (UCL) | London | W1W 7EJ | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19093357 | Background | 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. | |
| 16176199 | Background | 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. |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| 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 | 2 subscales of the HeiQ questionnaire. | baseline, 3 months, 9 months |
| 18373577 | Background | 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. |
| 17378871 | Background | 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. |
| 18166525 | Background | 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. |
| 16884582 | Background | 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. |
| 25803226 | Derived | 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. |