Diabetes MellitusNCT04999722
Establishment and Preliminary Evaluation of Digital Three Level Linkage Whole Process Diabetes Management System
A study testing Traditional mode of management and Mobile APP management in people with Diabetes Mellitus, run by Chongqing Renji Hospital, University of Chinese Academy of Sciences.
Trial summary
This study used Nan'an District of Chongqing, China as a pilot project to improve the comprehensive compliance rate of diabetic patients in China, and reduce the physical and economic harm caused by complications. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Traditional mode of management and Mobile APP management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,200 participants
- Where
- No sites listed yet
- Study dates
- 25 Aug 2021to 24 Jun 2022
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of type 2 diabetes.
- Aged 18-70;
- HbA1c ≥ 8.0%
Who cannot join
- Pregnancy;
- Chronic kidney disease (CKD stage 5);
- Senile dementia patients;
- With malignant tumor;
- Moderate and severe anemia;
- Severe liver dysfunction;
- Hemolytic anemia, aplastic anemia, massive blood loss or transfusion, chronic malaria;
- In the recent one week, large doses of salicylate, erythropoietin, antiretroviral drugs, ribavirin and other drugs that have an impact on the detection of glycosylated hemoglobin were used
About this study
This study used Nan'an District of Chongqing, China as a pilot project to improve the comprehensive compliance rate of diabetic patients in China, and reduce the physical and economic harm caused by complications.
- Conditions
- Diabetes Mellitus
- Being tested
- Traditional mode of management, Mobile APP management
- Keywords
- Diabetes Mellitus, Manage, Mobile app
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional mode of managementBehavioural
Traditional model management of Diabetes Mellitus patients
Mobile APP managementBehavioural
Management of diabetic patients with mobile phone APP
| Study group | Role | What they receive |
|---|---|---|
| APP group | Active comparator | Participants with diabetes who had access to a mobile APP Receives: Behavioral: Mobile APP management |
| Control Group | Placebo comparator | Diabetes participants who accepted the traditional management model Receives: Behavioral: Traditional mode of management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Glycated hemoglobin at 12 months
Changes of glycated hemoglobin （percentage）before and after management
Measured: Month 12
Secondary outcomes (3)
Change from Baseline Blood pressure at 12 months
Changes of blood pressure（mmHg） before and after management
Measured: Month 12
Change from Baseline blood lipid at 12 months
Changes of blood lipid （mmol/L）before and after management
Measured: Month 12
Change from Baseline Diabetic nephropathy at 12 months
Changes of Diabetic nephropathy（ratio） before and after management
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2021
- Study start25 Aug 2021 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion24 Jun 2022 (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
- Model description
- Mobile app was used for follow-up
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chongqing Renji Hospital, University of Chinese Academy of Sciences
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04999722
- Sponsor's protocol ID
- 2021CQSDWRMYYEC-004
- Status last verified
- Jul 2021
- First submitted
- 19 Jul 2021
- Last updated
- 11 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment and Preliminary Evaluation of Digital Three Level Linkage Whole Process Diabetes Management System
- ClinicalTrials.gov ID
- NCT04999722
- Acronym / sponsor ID
- 2021CQSDWRMYYEC-004
- Conditions
- Diabetes Mellitus
- Keywords
- Diabetes Mellitus, Manage, Mobile app
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Chongqing Renji Hospital, University of Chinese Academy of SciencesOther government
- Study start
- 25 Aug 2021 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 24 Jun 2022 (estimated)
- First posted
- 11 Aug 2021 (actual)
- 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.
This study used Nan'an District of Chongqing, China as a pilot project to improve the comprehensive compliance rate of diabetic patients in China, and reduce the physical and economic harm caused by complications.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Mobile app was used for follow-up
| Arm | Type | Receives |
|---|---|---|
| APP group | Active comparator | Behavioral: Mobile APP managementParticipants with diabetes who had access to a mobile APP |
| Control Group | Placebo comparator | Behavioral: Traditional mode of managementDiabetes participants who accepted the traditional management model |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of type 2 diabetes.
- Aged 18-70;
- HbA1c ≥ 8.0%
Key exclusion criteria (8 listed)
- Pregnancy;
- Chronic kidney disease (CKD stage 5);
- Senile dementia patients;
- With malignant tumor;
- Moderate and severe anemia;
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 |
|---|---|---|
| Traditional mode of managementTraditional model management of Diabetes Mellitus patients | Behavioural | Control Group |
| Mobile APP managementManagement of diabetic patients with mobile phone APP | Behavioural | APP group |
Primary outcome
Change from Baseline Glycated hemoglobin at 12 months
Time frame: Month 12
Changes of glycated hemoglobin （percentage）before and after management
3 secondary outcomes
Change from Baseline Blood pressure at 12 months
Time frame: Month 12
Change from Baseline blood lipid at 12 months
Time frame: Month 12
Change from Baseline Diabetic nephropathy at 12 months
Time frame: Month 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2021.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional mode of management and Mobile APP management in people with Diabetes Mellitus, run by Chongqing Renji Hospital, University of Chinese Academy of Sciences.
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 8 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 11 Aug 2021. 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. Some participants in this study may receive a placebo. 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?
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 from Baseline Glycated hemoglobin at 12 months (time frame: Month 12). 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 11 Aug 2021.