Diabetes MellitusNCT02313090
Study of Welltang- a Cell Phone-based Diabetes Management Application's Effect on Blood Glucose Control
A study testing Welltang in people with Diabetes Mellitus, run by First Affiliated Hospital of Zhejiang University.
Trial summary
The aim was to assess the impact of a cell phone-based diabetes management application (Welltang) on HbA1c, blood glucose, lipids, physical activity, weight, and blood pressure during 3 months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Welltang
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to May 2014
- 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
- All diabetes, aged more than 18 years old. No limit for HbA1c was defined
Who cannot join
- patients have any severe complications such as end phase of diabetic nephropathy or proliferative retinopathy. patients who cannot use smart phone.
About this study
The aim was to assess the impact of a cell phone-based diabetes management application (Welltang) on HbA1c, blood glucose, lipids, physical activity, weight, and blood pressure during 3 months. And hypoglycemic events, the satisfaction of the patients with Boyibang, their diabetes knowledge and self-care behaviors were also evaluated.
Read the detailed description
At baseline, all patients completed the Diabetes Self- Care Behavior Questionnaire and a Diabetes Knowledge Survey. Health, medical and demographic history, height and weight, waist and hip circumferences, and blood pressure were recorded. HbA1c and low-density lipoprotein cholesterol (LDL-C) level were tested. All of these data were measured 3 months later at the conclusion of the study intervention.
- Conditions
- Diabetes Mellitus
- Being tested
- Welltang
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WelltangOther
The intervention group installed Welltang (downloaded from www.welltang.com for free) designed by Shanghai Geping Information and Technique Company Ltd (Shanghai, China) on their cell phones. Welltang is a cell phone- based diabetes management application that consists of three main parts: knowledge, self-management, communication between patients and clinicians
| Study group | Role | What they receive |
|---|---|---|
| Welltang | Experimental | patients using Welltang Receives: Other: Welltang |
| usual standard care | No intervention | patients under usual standard of diabetic care |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Measured: 3 months
Secondary outcomes (2)
blood pressure
Measured: 3 months
low density lipoprotein cholesterol
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2014 (estimated)
- Study startJan 2014
- Primary completionMay 2014
- Study completionMay 2014
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.
- More trials run by First Affiliated Hospital of Zhejiang UniversityThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhou Weibin, First Affiliated Hospital of Zhejiang University
- Investigators
- Weibin Zhou, phD, Principal investigator, the First Affiliated Hospital to Zhejiang University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02313090
- Sponsor's protocol ID
- ChiCTR-IOR-14005515
- Status last verified
- Dec 2014
- First submitted
- 25 Nov 2014
- Last updated
- 9 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Welltang- a Cell Phone-based Diabetes Management Application's Effect on Blood Glucose Control
- ClinicalTrials.gov ID
- NCT02313090
- Acronym / sponsor ID
- ChiCTR-IOR-14005515
- Conditions
- Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 9 Dec 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.
The aim was to assess the impact of a cell phone-based diabetes management application (Welltang) on HbA1c, blood glucose, lipids, physical activity, weight, and blood pressure during 3 months. And hypoglycemic events, the satisfaction of the patients with Boyibang, their diabetes knowledge and self-care behaviors were also evaluated.
Detailed description
At baseline, all patients completed the Diabetes Self- Care Behavior Questionnaire and a Diabetes Knowledge Survey. Health, medical and demographic history, height and weight, waist and hip circumferences, and blood pressure were recorded. HbA1c and low-density lipoprotein cholesterol (LDL-C) level were tested. All of these data were measured 3 months later at the conclusion of the study intervention.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Welltang | Experimental | Other: Welltangpatients using Welltang |
| usual standard care | No intervention | –patients under usual standard of diabetic care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All diabetes, aged more than 18 years old. No limit for HbA1c was defined
Key exclusion criteria (1 listed)
- patients have any severe complications such as end phase of diabetic nephropathy or proliferative retinopathy. patients who cannot use smart phone.
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 |
|---|---|---|
| WelltangThe intervention group installed Welltang (downloaded from www.welltang.com for free) designed by Shanghai Geping Information and Technique Company Ltd (Shanghai, China) on their cell phones. Welltang is a cell phone- based diabetes management application that consists of three main parts: knowledge, self-management, communication between patients and clinicians | Other | Welltang |
Primary outcome
HbA1c
Time frame: 3 months
2 secondary outcomes
blood pressure
Time frame: 3 months
low density lipoprotein cholesterol
Time frame: 3 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 9 Dec 2014.
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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.
Weibin Zhou, phD principal investigator
the First Affiliated Hospital to Zhejiang University School of Medicine
Questions about this trial
What is this clinical trial studying?
A study testing Welltang in people with Diabetes Mellitus, run by First Affiliated Hospital of Zhejiang University.
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 1 inclusion and 1 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 9 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
HbA1c (time frame: 3 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 9 Dec 2014.