Diabetes (Insulin-requiring, Type 1 or Type 2)T+NCT00922376
Assessment of the Clinical Efficacy and Acceptability of Think Positive (T+) in Diabetes Management
A study testing Mobile phone telehealth application: Think Positive (T+) in people with Diabetes (Insulin-requiring, Type 1 or Type 2), run by University College London Hospitals at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes (Insulin-requiring, Type 1 or Type 2)
- What is being tested?
- Mobile phone telehealth application: Think Positive (T+)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2010to Nov 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Clinical Efficacy and Acceptability of the Think Positive (T+) Diabetes Management System in Insulin Requiring Diabetes
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.
- Being tested
- Mobile phone telehealth application: Think Positive (T+)
- Keywords
- Diabetes, self- management, glycemic control, telehealth, mhealth
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Mobile phone telehealth application: Think Positive (T+) |
| Usual care | No intervention | The control group will be receiving the standard care offered by the NHS to patients suffering from diabetes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood sugar levels (HbA1c)
Measured: Baseline, 3 months, 9 months
Secondary outcomes (13)
BMI
Measured: Baseline, 3 months, 9 months
Number of Hypoglycemic events
Measured: Baseline, 3 months, 9 months
Blood pressure
Measured: Baseline, 3 months, 9 months
Diabetes self-care
Measured: Baseline, 3 months, 9 months
Diabetes self- efficacy
Measured: Baseline, 3 months, 9 months
Quality of life
Measured: Baseline, 3 months, 9 months
Health status
Measured: Baseline, 3 months, 9 months
Illness representations
Measured: Baseline, 3 months, 9 months
User acceptability of T+
Measured: 3 months, 9 months
Nurses' Perceptions of T+
Measured: Baseline, 3 months, 9 months
Self efficacy in using T+
Measured: 3 months, 9 months
Health care utilization
Measured: baseline, 3 months, 9 months
Self management
2 subscales of the HeiQ questionnaire.
Measured: baseline, 3 months, 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2009 (estimated)
- Study startJun 2010
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Diabetes (Insulin-requiring, Type 1 or Type 2)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College London Hospitals
- Sponsor type
- University, hospital or other
- Collaborators
- University College, London, Department of Health, United Kingdom
- Responsible party
- Principal investigator, Justine Baron, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00922376
- Sponsor's protocol ID
- 09/0201
- Acronym
- T+
- Status last verified
- Apr 2012
- First submitted
- 16 Jun 2009
- Last updated
- 10 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
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 19093357Farmer 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 16176199Faridi 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 18373577Jaana 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 17378871Kollmann 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 18166525Wangberg 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 16884582Baron 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
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Clinical Efficacy and Acceptability of the Think Positive (T+) Diabetes Management System in Insulin Requiring Diabetes
- ClinicalTrials.gov ID
- NCT00922376
- Acronym / sponsor ID
- T+ / 09/0201
- Keywords
- Diabetes, self- management, glycemic control, telehealth, mhealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- University College London HospitalsUniversity, hospital or other
- Collaborators
- University College, London, Department of Health, United Kingdom
- Study start
- Jun 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 17 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| T+ Intervention | Active comparator | Device: Mobile phone telehealth application: Think Positive (T+)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- Psychiatric disorders
- Poor vision or/and lack of manual dexterity
- Prior use of T+
- Participation in another ongoing trial
- Patients with antenatal/gestational
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile 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. | Device | T+ Intervention |
Primary outcome
Blood sugar levels (HbA1c)
Time frame: Baseline, 3 months, 9 months
13 secondary outcomes
BMI
Time frame: Baseline, 3 months, 9 months
Number of Hypoglycemic events
Time frame: Baseline, 3 months, 9 months
Blood pressure
Time frame: Baseline, 3 months, 9 months
Diabetes self-care
Time frame: Baseline, 3 months, 9 months
Diabetes self- efficacy
Time frame: Baseline, 3 months, 9 months
Quality of life
Time frame: Baseline, 3 months, 9 months
Health status
Time frame: Baseline, 3 months, 9 months
Illness representations
Time frame: Baseline, 3 months, 9 months
User acceptability of T+
Time frame: 3 months, 9 months
Nurses' Perceptions of T+
Time frame: Baseline, 3 months, 9 months
Self efficacy in using T+
Time frame: 3 months, 9 months
Health care utilization
Time frame: baseline, 3 months, 9 months
Self management
Time frame: baseline, 3 months, 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2012.
- Background: PubMed 19093357Blake 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.
- Background: PubMed 16176199Farmer 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.
- Background: PubMed 18373577Faridi 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.
- Background: PubMed 17378871Jaana 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.
- Background: PubMed 18166525Kollmann 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.
- Background: PubMed 16884582Wangberg SC, Arsand E, Andersson N. Diabetes education via mobile text messaging. J Telemed Telecare. 2006;12 Suppl 1:55-6. doi: 10.1258/135763306777978515.
- Derived from this study: PubMed 25803226Baron 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile phone telehealth application: Think Positive (T+) in people with Diabetes (Insulin-requiring, Type 1 or Type 2), run by University College London Hospitals at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood sugar levels (HbA1c) (time frame: Baseline, 3 months, 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00922376, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2012.