Diabetes Mellitus, Type 2NCT03588000
The Effect of Remote SMBG Combined With the Application of APP on the Improvement of T2DM Management in the Community
A study testing Strengthen self-monitoring of blood glucose in people with Diabetes Mellitus, Type 2, run by Yuwen Zhang at 1 site in China.
Trial summary
To investigate whether strengthen community diabetes patients self-monitoring of blood glucose can improve the patient's blood glucose control under Chinese guidelines for the prevention and treatment of diabetes (CDS 2017) and whether this intervention produces health and economic benefits. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Strengthen self-monitoring of blood glucose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 498 participants
- Where
- 1 siteChina
- Study dates
- 23 Nov 2018to 16 Apr 2021
- 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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of type 2 Diabetes
- Between 18 and 79 years old
- 7.0%<HbA1c ≤ 9.5%
- Routinely uses a smart phone
- Capability of operating the designated APP
- Long-time residents in Jiading District, Shanghai, China
Show all 10Show fewer
- Subordinated to Shanghai medical insurance
- Contracted residents of community in Jiading District, Shanghai, China
- Being cognitively able to participate
- Provision of written informed consent
Who cannot join
- Type 1 diabetes, gestational diabetes mellitus or other types of diabetes mellitus
- Currently pregnant or contemplating pregnancy within the next 24 months
- Lactating women
- Was not able to insist until the end (24 months)
- Cognitive impairment
- Migrant population
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Remote Self-monitoring of Blood Glucose (SMBG) Combined With the Promotion and Application of Internet Mobile Terminal (APP) on the Improvement of the Staged Type 2 Diabetes Mellitus (T2DM) Management and the Success Rate of Blood Glucose in the Community
To investigate whether strengthen community diabetes patients self-monitoring of blood glucose can improve the patient's blood glucose control under Chinese guidelines for the prevention and treatment of diabetes (CDS 2017) and whether this intervention produces health and economic benefits.
Read the detailed description
This project is a cohort intervention study for randomized controlled trials. Community health service centers are the main body of implementing treatment and community diabetes patients are the objects of intervention. 498 T2DM patients with poor blood glucose control (7%<HbA1c≤9.5%) from 4 different community health service centers will be randomized into two groups (strengthen group and control group). Strengthen self-monitoring of blood glucose by APP is the intervention and its duration is 12 months. Follow-up time of this study is 24 months (12 months after the intervention stopped). The diabetes treatment of patients from both groups follows Chinese guidelines (CDS 2017).
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Strengthen self-monitoring of blood glucose
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strengthen self-monitoring of blood glucoseOther
Strengthen self-monitoring of blood glucose by Internet mobile terminal（APP）.
| Study group | Role | What they receive |
|---|---|---|
| Strength group | Experimental | Strengthen self-monitoring of blood glucose by Internet mobile terminal (APP) Receives: Other: Strengthen self-monitoring of blood glucose |
| Control group | No intervention | Voluntary self-monitoring of blood glucose |
What is being measured
The primary outcome is the main question the study is designed to answer.
absolute change in % HbA1c from baseline to 12 months
absolute change in glycemic control (% HbA1c) from baseline to 12 months
Measured: baseline to 12 months
Secondary outcomes (5)
absolute change in % HbA1c from baseline to 6 months
absolute change in glycemic control (% HbA1c) from baseline to 6 months
Measured: baseline to 6 months
absolute change in % HbA1c from baseline at 24 months
absolute change in glycemic control (% HbA1c) from baseline to 24 months
Measured: baseline to 24 months
change in blood glucose from baseline to 6 month
change in fasting and postprandial blood glucose from baseline to 6 month
Measured: baseline to 6 months
change in blood glucose from baseline to 12 month
change in fasting and postprandial blood glucose from baseline to 12 month
Measured: baseline to 12 months
change in blood glucose from baseline to 24 month
change in fasting and postprandial blood glucose from baseline to 24 month
Measured: baseline to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2018
- Study start23 Nov 2018
- Primary completion28 Feb 2021
- Study completion16 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- 498 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuwen Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yuwen Zhang, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03588000
- Sponsor's protocol ID
- 16CR4020A
- Status last verified
- Sep 2021
- First submitted
- 7 Jun 2018
- Last updated
- 21 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Remote Self-monitoring of Blood Glucose (SMBG) Combined With the Promotion and Application of Internet Mobile Terminal (APP) on the Improvement of the Staged Type 2 Diabetes Mellitus (T2DM) Management and the Success Rate of Blood Glucose in the Community
- ClinicalTrials.gov ID
- NCT03588000
- Acronym / sponsor ID
- 16CR4020A
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 498 participants (actual)
- Lead sponsor
- Yuwen ZhangUniversity, hospital or other
- Study start
- 23 Nov 2018 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 16 Apr 2021 (actual)
- First posted
- 17 Jul 2018 (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.
To investigate whether strengthen community diabetes patients self-monitoring of blood glucose can improve the patient's blood glucose control under Chinese guidelines for the prevention and treatment of diabetes (CDS 2017) and whether this intervention produces health and economic benefits.
Detailed description
This project is a cohort intervention study for randomized controlled trials. Community health service centers are the main body of implementing treatment and community diabetes patients are the objects of intervention. 498 T2DM patients with poor blood glucose control (7%<HbA1c≤9.5%) from 4 different community health service centers will be randomized into two groups (strengthen group and control group). Strengthen self-monitoring of blood glucose by APP is the intervention and its duration is 12 months. Follow-up time of this study is 24 months (12 months after the intervention stopped). The diabetes treatment of patients from both groups follows Chinese guidelines (CDS 2017).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Strength group | Experimental | Other: Strengthen self-monitoring of blood glucoseStrengthen self-monitoring of blood glucose by Internet mobile terminal (APP) |
| Control group | No intervention | –Voluntary self-monitoring of blood glucose |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Diagnosis of type 2 Diabetes
- Between 18 and 79 years old
- 7.0%<HbA1c ≤ 9.5%
- Routinely uses a smart phone
- Capability of operating the designated APP
Key exclusion criteria (6 listed)
- Type 1 diabetes, gestational diabetes mellitus or other types of diabetes mellitus
- Currently pregnant or contemplating pregnancy within the next 24 months
- Lactating women
- Was not able to insist until the end (24 months)
- Cognitive 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 |
|---|---|---|
| Strengthen self-monitoring of blood glucoseStrengthen self-monitoring of blood glucose by Internet mobile terminal（APP）. | Other | Strength group |
Primary outcome
absolute change in % HbA1c from baseline to 12 months
Time frame: baseline to 12 months
absolute change in glycemic control (% HbA1c) from baseline to 12 months
5 secondary outcomes
absolute change in % HbA1c from baseline to 6 months
Time frame: baseline to 6 months
absolute change in % HbA1c from baseline at 24 months
Time frame: baseline to 24 months
change in blood glucose from baseline to 6 month
Time frame: baseline to 6 months
change in blood glucose from baseline to 12 month
Time frame: baseline to 12 months
change in blood glucose from baseline to 24 month
Time frame: baseline to 24 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 21 Sep 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strengthen self-monitoring of blood glucose in people with Diabetes Mellitus, Type 2, run by Yuwen Zhang 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 10 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 21 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 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?
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?
absolute change in % HbA1c from baseline to 12 months (time frame: baseline to 12 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 21 Sep 2021.