Type 2 Diabetes MellitusNCT02370719
Evaluation of an mHealth Behavioural Intervention for the Self-Management for Type 2 Diabetes
A study testing Mobile application for diabetes self-management in people with Type 2 Diabetes Mellitus, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
The purpose of this study is to evaluate a patient-centered diabetes self-management mobile application (app), which was developed with feedback from both patients and healthcare providers. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Mobile application for diabetes self-management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteCanada
- Study dates
- 28 Jun 2015to 28 Oct 2017
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English-speaking individuals
- Diagnosed with non-insulin requiring type 2 diabetes
- Outpatients
- Baseline A1c of 7.5% or higher
Who cannot join
- Patients who are deemed unable to use a mobile phone (e.g. due to vision problems), and/or to comply with home monitoring (e.g. suffering from anxiety or depression)
- Diabetes duration <1 year
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of an mHealth Behavioural Intervention for the Self-Management for Type 2 Diabetes Mellitus
The purpose of this study is to evaluate a patient-centered diabetes self-management mobile application (app), which was developed with feedback from both patients and healthcare providers. During the 12 month randomized control trial, participants in the intervention group will be provided with a mobile phone and commercial home medical devices, such as a weight scale, glucometer and activity monitor. The measurements taken from the medical devices will wirelessly transfer to the mobile phone, where the app will assess the data and provide patients with actionable self-management knowledge. The proposed intervention may be helpful in increasing adherence to recommended self-care practices, improving self-efficacy, and enhancing the overall patient experience.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Mobile application for diabetes self-management
- Keywords
- Diabetes mellitus, Randomized controlled trial, Primary care, Physical activity, Lifestyle, Blood glucose, Mobile health, Hb A1c, Self-management
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile application for diabetes self-managementBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Mobile application plus standard of care Receives: Behavioral: Mobile application for diabetes self-management |
| Control Group | No intervention | Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c from baseline to 12 months
Measured: Baseline, 3, 6, 9 and 12 months
Secondary outcomes (9)
Blood pressure
Measured: Baseline, 3, 6, 9 and 12 months
Weight
Measured: Baseline, 3, 6, 9 and 12 months
Cholesterol (LDL and total)
Measured: Baseline, 6 and 12 months
Medication changes
Measured: 3, 6, 9 and 12 months
Glycemic excursions
Measured: 3, 6, 9 and 12 months
BMI
Measured: Baseline, 3, 6, 9 and 12 months
Diabetes Distress Scale
Measured: Baseline, 6 and 12 months
Diabetes Empowerment Scale
Measured: Baseline, 6 and 12 months
Summary of Diabetes Self-Care Activities
Measured: Baseline, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2015 (estimated)
- Study start28 Jun 2015
- Primary completion28 Oct 2017
- Study completion28 Oct 2017
Why it stopped: Due to the inability to recruit the required number of participants, the study has been terminated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- 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
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- MOUNT SINAI HOSPITAL, University of Toronto, Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Joseph Cafazzo, University Health Network, Toronto
- Investigators
- Joseph A Cafazzo, PEng, PhD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02370719
- Sponsor's protocol ID
- BantII
- Status last verified
- Sep 2021
- First submitted
- 18 Feb 2015
- Last updated
- 13 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Goyal S, Lewis G, Yu C, Rotondi M, Seto E, Cafazzo JA. Evaluation of a Behavioral Mobile Phone App Intervention for the Self-Management of Type 2 Diabetes: Randomized Controlled Trial Protocol. JMIR Res Protoc. 2016 Aug 19;5(3):e174. doi: 10.2196/resprot.5959.
PubMed 27542325
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an mHealth Behavioural Intervention for the Self-Management for Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT02370719
- Acronym / sponsor ID
- BantII
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Diabetes mellitus, Randomized controlled trial, Primary care, Physical activity, Lifestyle, Blood glucose, Mobile health, Hb A1c
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to the inability to recruit the required number of participants, the study has been terminated.
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- MOUNT SINAI HOSPITAL, University of Toronto, Canadian Institutes of Health Research (CIHR)
- Study start
- 28 Jun 2015
- Primary completion
- 28 Oct 2017 (actual)
- Study completion
- 28 Oct 2017 (actual)
- First posted
- 25 Feb 2015 (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.
The purpose of this study is to evaluate a patient-centered diabetes self-management mobile application (app), which was developed with feedback from both patients and healthcare providers. During the 12 month randomized control trial, participants in the intervention group will be provided with a mobile phone and commercial home medical devices, such as a weight scale, glucometer and activity monitor. The measurements taken from the medical devices will wirelessly transfer to the mobile phone, where the app will assess the data and provide patients with actionable self-management knowledge. The proposed intervention may be helpful in increasing adherence to recommended self-care practices, improving self-efficacy, and enhancing the overall patient experience.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Mobile application for diabetes self-managementMobile application plus standard of care |
| Control Group | No intervention | –Standard of care |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- English-speaking individuals
- Diagnosed with non-insulin requiring type 2 diabetes
- Outpatients
- Baseline A1c of 7.5% or higher
Key exclusion criteria (2 listed)
- Patients who are deemed unable to use a mobile phone (e.g. due to vision problems), and/or to comply with home monitoring (e.g. suffering from anxiety or depression)
- Diabetes duration <1 year
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 application for diabetes self-management | Behavioural | Intervention Group |
Primary outcome
Change in HbA1c from baseline to 12 months
Time frame: Baseline, 3, 6, 9 and 12 months
9 secondary outcomes
Blood pressure
Time frame: Baseline, 3, 6, 9 and 12 months
Weight
Time frame: Baseline, 3, 6, 9 and 12 months
Cholesterol (LDL and total)
Time frame: Baseline, 6 and 12 months
Medication changes
Time frame: 3, 6, 9 and 12 months
Glycemic excursions
Time frame: 3, 6, 9 and 12 months
BMI
Time frame: Baseline, 3, 6, 9 and 12 months
Diabetes Distress Scale
Time frame: Baseline, 6 and 12 months
Diabetes Empowerment Scale
Time frame: Baseline, 6 and 12 months
Summary of Diabetes Self-Care Activities
Time frame: Baseline, 6 and 12 months
Results and safety
The study was stopped early (reason given: Due to the inability to recruit the required number of participants, the study has been terminated.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2021.
- Derived from this study: PubMed 27542325Goyal S, Lewis G, Yu C, Rotondi M, Seto E, Cafazzo JA. Evaluation of a Behavioral Mobile Phone App Intervention for the Self-Management of Type 2 Diabetes: Randomized Controlled Trial Protocol. JMIR Res Protoc. 2016 Aug 19;5(3):e174. doi: 10.2196/resprot.5959.
Related trials for Type 2 Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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.
Joseph A Cafazzo, PEng, PhD principal investigator
University Health Network, Toronto
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 application for diabetes self-management in people with Type 2 Diabetes Mellitus, run by University Health Network, Toronto at 1 site in Canada.
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 4 inclusion and 2 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: stopped early, as of the sponsor's last update on 13 Sep 2021. 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 Canada. 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 was stopped early (reason given: Due to the inability to recruit the required number of participants, the study has been terminated.). Results are not available in the source record.
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?
Change in HbA1c from baseline to 12 months (time frame: Baseline, 3, 6, 9 and 12 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 NCT02370719, which also lists 1 linked publication.
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 13 Sep 2021.