Diabetes (Insulin-requiring, Type 1 or Type 2)
Conditions
Keywords
Diabetes, self- management, glycemic control, telehealth, mhealth
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.
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.
Sponsors
University College, London
Department of Health, United Kingdom
University College London Hospitals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood sugar levels (HbA1c) | Baseline, 3 months, 9 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 2 subscales of the HeiQ questionnaire. |
Countries
United Kingdom
Outcome results
None listed