Short-term insulin therapy using pumps and glucose monitoring for newly diagnosed type 2 diabetes
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
This study is testing if using insulin pumps and continuous glucose monitoring can help people recently diagnosed with type 2 diabetes get better and possibly reverse their condition.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 210 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Locations | 1 site (Guandong) |
| Trial ID | NCT06127433 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness and safety of a short-term insulin intensive therapy model that combines the use of insulin pumps and continuous glucose monitoring technology. It involves a randomized controlled approach to evaluate how well this method can help reverse newly diagnosed type 2 diabetes. The study aims to assess blood glucose parameters to predict long-term remission and improve the precision and integration of diabetes management. Participants will receive insulin glargine, metformin, dapagliflozin, and insulin aspart as part of their treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 with newly diagnosed type 2 diabetes who have not received prior hypoglycemic treatment.
Not a fit: Patients with type 1 diabetes or those with acute complications of diabetes may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to significant improvements in managing and potentially reversing newly diagnosed type 2 diabetes.
How similar studies have performed: Other studies have shown promising results with similar insulin therapy approaches, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:1: Have never received any hypoglycemic treatment (including oral hypoglycemic drugs, traditional Chinese medicine hypoglycemic drugs, insulin) Type 2 diabetes patients, or type 2 diabetes patients with diagnosis time less than 1 year, use hypoglycemic drugs No more than 1 type, with a usage time of no more than 1 week, and discontinuation of medication for more than 1 week when selected 2: A1c of glycosylated hemoglobin ≥ 8.0%, and abdominal blood glucose\>7.0mmol/L during enrollment 3: Age range from 18 to 70 years old, with a body mass index (BMI) of 20-35kg/m2 4: agrees to use contraception during the study process 5: Able and willing to use a dynamic blood glucose system and monitor blood glucose according to project requirements, and accept out of hospital lifestyle management and insulin hypoglycemic management. - Exclusion Criteria:1: Not type 2 diabetes 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 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 -
Where this trial is running
Guandong
- 刘烈华 — Guandong, China (Recruiting)
Study contacts
- Study coordinator: Li Yanbing
- Email: liyb@mail.sysu.edu.cn
- Phone: 13925111691
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.