Diabetes MellitusNCT02124408
Mobile Phone Personalized Intervention for Diabetes
A study testing Personalized Behavioral Intervention in people with Diabetes Mellitus, run by Ningbo Beilun District Traditional Chinese Medicine Hospital at 1 site in China.
Trial summary
With the development of economy and change of lifestyles, it is characterized that there is a dramatic increase of diabetes in China. Changes in lifestyle/self-care behaviors by diabetes patients are required to improve blood glucose and subsequent outcomes. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Personalized Behavioral Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- Nov 2013to Dec 2015
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Physician diagnosis of type 2 diabetes
- Age 20 years and more
- The local resident
Who cannot join
- Not currently managed by study physicians
- Pregnant
- Active substance, alcohol, or drug abuser
- Psychotic or schizophrenic under activecare
- Severe hearing or visual impairment
- No telephone or mobile phone
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ningbo Beilun District Traditional Chinese Medicine Hospital
Ningbo, Zhejiang, 315800
Manhong Zhao, MD, +86-574-86784207, maohongzhao12@126.com
About this study
With the development of economy and change of lifestyles, it is characterized that there is a dramatic increase of diabetes in China. Changes in lifestyle/self-care behaviors by diabetes patients are required to improve blood glucose and subsequent outcomes. Mobile phone intervention was a kind of high cost efficiency and high quality health care. Our study evaluated a diabetes coaching system, using mobile phones and patient/provider portals for patient-specific treatment and communication.
- Conditions
- Diabetes Mellitus
- Being tested
- Personalized Behavioral Intervention
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized Behavioral InterventionBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Personalized Behavioral Intervention Receives: Behavioral: Personalized Behavioral Intervention |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in glycated hemoglobin levels
Blood sample would be collected and HbA1C level would be assessed in baseline and 6 months later.Change in glycated hemoglobin levels will be compared between the two group.
Measured: baseline and 6 months
Secondary outcomes (2)
changes in patient-reported diabetes symptoms
Diabetes symptoms such as polydipsia, polyuria and polyphagia of all participants would be obtained by questionnaire in baseline and 6 months and compared between the two groups.
Measured: baseline and 6 months
control of diabetic complications
Blood pressure, blood lipid, weight and sleep quality etc.would be obtained by physical or lab examination or questionnaire in baseline and 6 months. The percentage of patients with well-control of blood pressure (BP≤130/80mmHg),weight (BMI≤24kg/m2) and sleep quality(PSQI score≤5) etc.will be compared between the two groups.
Measured: baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2014 (estimated)
- Study startNov 2013
- Primary completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ningbo Beilun District Traditional Chinese Medicine Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02124408
- Sponsor's protocol ID
- H20132175
- Status last verified
- Apr 2014
- First submitted
- 19 Apr 2014
- Last updated
- 28 Apr 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Phone Personalized Intervention for Diabetes
- ClinicalTrials.gov ID
- NCT02124408
- Acronym / sponsor ID
- H20132175
- Conditions
- Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Ningbo Beilun District Traditional Chinese Medicine HospitalUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Dec 2015 (estimated)
- First posted
- 28 Apr 2014 (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.
With the development of economy and change of lifestyles, it is characterized that there is a dramatic increase of diabetes in China. Changes in lifestyle/self-care behaviors by diabetes patients are required to improve blood glucose and subsequent outcomes. Mobile phone intervention was a kind of high cost efficiency and high quality health care. Our study evaluated a diabetes coaching system, using mobile phones and patient/provider portals for patient-specific treatment and communication.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Personalized Behavioral InterventionPersonalized Behavioral Intervention |
| Control group | No intervention | – |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Physician diagnosis of type 2 diabetes
- Age 20 years and more
- The local resident
Key exclusion criteria (6 listed)
- Not currently managed by study physicians
- Pregnant
- Active substance, alcohol, or drug abuser
- Psychotic or schizophrenic under activecare
- Severe hearing or visual impairment
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 |
|---|---|---|
| Personalized Behavioral Intervention | Behavioural | Intervention group |
Primary outcome
change in glycated hemoglobin levels
Time frame: baseline and 6 months
Blood sample would be collected and HbA1C level would be assessed in baseline and 6 months later.Change in glycated hemoglobin levels will be compared between the two group.
2 secondary outcomes
changes in patient-reported diabetes symptoms
Time frame: baseline and 6 months
control of diabetic complications
Time frame: baseline and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2015.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized Behavioral Intervention in people with Diabetes Mellitus, run by Ningbo Beilun District Traditional Chinese Medicine Hospital at 1 site in China.
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 3 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: status not confirmed, as of the sponsor's last update on 28 Apr 2015. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Manhong Zhao, MD (+86-574-86784207, zhaomanhong12@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in glycated hemoglobin levels (time frame: baseline and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Apr 2015.