Insulin Pump，Continuous Glucose Monitoring TechnologyPhase 4NCT06127433
The Effect of Short-term Insulin Intensive Therapy Based on the Application of Insulin Pump and Real-time Dynamic Glucose Monitoring Technology on Reversing the Newly Diagnosed Type 2 Diabetes
A Phase 4 study testing Insulin Glargine, Metformin and Dapagliflozin in people with Insulin Pump，Continuous Glucose Monitoring Technology, run by Sun Yat-sen University at 1 site in China.
Trial summary
This study aims to explore the effectiveness and safety of the in-hospital-out-of-hospital synergistic short-term insulin intensive therapy model based on patch insulin pump and continuous glucose monitoring technology through a randomized controlled study, and evaluate the possibility of blood glucose parameters… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Insulin Pump，Continuous Glucose Monitoring Technology
- What is being tested?
- Insulin Glargine, Metformin and Dapagliflozin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteChina
- Study dates
- 7 Mar 2023to 30 Dec 2024
- Phase
- Phase 4
- 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
None listed.
Who cannot join
- 2: The medication used is allergic or intolerable
- 3: Acute complications of diabetes
- 4: Severe microvascular complications
- 5: Severe macrovascular complications
- 6: Blood pressure consistently exceeds 180/110mmHg and cannot be controlled within 160/110mmHg within 1 week
- 7: The clearance rate of blood creatinine is less than 45ml/min/1.73m2, the ALT is ≥ 3 times the normal upper limit, and the total bilirubin is ≥ 2 times the normal upper limit and lasts for more than 1 week
Show all 17Show fewer
- 8: Hemoglobin<100g/L or requires regular blood transfusion treatment
- 9: Accumulated time of using drugs that may affect blood sugar within 12 weeks for more than 1 week
- 10: Systemic infection or severe accompanying diseases
- 11: Patients with malignant tumors or chronic diarrhea
- 12: Uncontrolled endocrine gland dysfunction
- 13: Mental disorders
- 14: Chronic heart failure, with a heart function grading of III or above
- 15: Pregnant, breastfeeding, women of childbearing age who are unwilling to use contraception during the study period, or have surgery plans that require general anesthesia in the near future (within 6 months)
- 16: The subject is uncooperative, unable to follow up, or the researcher determines that it may be difficult to complete the study.
- 17: Other situations that the researcher determines are not suitable for inclusion
- -
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to explore the effectiveness and safety of the in-hospital-out-of-hospital synergistic short-term insulin intensive therapy model based on patch insulin pump and continuous glucose monitoring technology through a randomized controlled study, and evaluate the possibility of blood glucose parameters derived from continuous glucose technology in predicting long-term blood glucose remission, so as to provide important reference data for the precision, intelligence, and integrated improvement of short-term insulin intensive therapy.
- Being tested
- Insulin Glargine, Metformin, Dapagliflozin, Insulin aspart
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin GlargineDrug
Insulin Glargine
MetforminDrug
Metformin
DapagliflozinDrug
Dapagliflozin
Insulin aspartDrug
Insulin aspart
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | Intervention：insulin pump intensive therapy Receives: Drug: Insulin aspart |
| control group | Active comparator | basal insulin and oral antidiabetic drugs Receives: Drug: Insulin Glargine; Drug: Metformin; Drug: Dapagliflozin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intergroup remission rate at 24 week
Fasting blood glucose<7mmol/L, and glycated hemoglobin<6.5%
Measured: 24 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start7 Mar 2023
- Primary completion1 May 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin Pump，Continuous Glucose Monitoring TechnologyStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- basal insulin and oral antidiabetic drugs group insulin intensive therapy group
- Masking
- None (open label)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanbing Li, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06127433
- Sponsor's protocol ID
- IIT-2022-816
- Status last verified
- Nov 2023
- First submitted
- 7 Nov 2023
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Short-term Insulin Intensive Therapy Based on the Application of Insulin Pump and Real-time Dynamic Glucose Monitoring Technology on Reversing the Newly Diagnosed Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT06127433
- Acronym / sponsor ID
- IIT-2022-816
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 7 Mar 2023 (actual)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 13 Nov 2023 (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 aims to explore the effectiveness and safety of the in-hospital-out-of-hospital synergistic short-term insulin intensive therapy model based on patch insulin pump and continuous glucose monitoring technology through a randomized controlled study, and evaluate the possibility of blood glucose parameters derived from continuous glucose technology in predicting long-term blood glucose remission, so as to provide important reference data for the precision, intelligence, and integrated improvement of short-term insulin intensive therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- basal insulin and oral antidiabetic drugs group insulin intensive therapy group
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Drug: Insulin aspartIntervention：insulin pump intensive therapy |
| control group | Active comparator | Drug: Insulin Glargine, Drug: Metformin, Drug: Dapagliflozinbasal insulin and oral antidiabetic drugs |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (17 listed)
- 2: The medication used is allergic or intolerable
- 3: Acute complications of diabetes
- 4: Severe microvascular complications
- 5: Severe macrovascular complications
- 6: Blood pressure consistently exceeds 180/110mmHg and cannot be controlled within 160/110mmHg within 1 week
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 |
|---|---|---|
| Insulin GlargineInsulin Glargine | Drug | control group |
| MetforminMetformin | Drug | control group |
| DapagliflozinDapagliflozin | Drug | control group |
| Insulin aspartInsulin aspart | Drug | intervention group |
Primary outcome
Intergroup remission rate at 24 week
Time frame: 24 week
Fasting blood glucose<7mmol/L, and glycated hemoglobin<6.5%
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- Individual participant dataSharing planned: Yes
Related trials for Insulin Pump，Continuous Glucose Monitoring Technology
Recruiting
Starting Technology in At Risk Type 1 Diabetes Study
Diabetes Mellitus, Type 1
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 Phase 4 study testing Insulin Glargine, Metformin and Dapagliflozin in people with Insulin Pump，Continuous Glucose Monitoring Technology, run by Sun Yat-sen University 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 0 inclusion and 17 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 13 Nov 2023. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Li Yanbing (13925111691, liyb@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intergroup remission rate at 24 week (time frame: 24 week). 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 13 Nov 2023.