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Effect of short-term intensive insulin therapy and lifestyle intervention on type 2 diabetes remission: study protocol of quasi-experiment

Effect of short-term intensive insulin therapy and lifestyle intervention on type 2 diabetes remission: study protocol of quasi-experiment

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500113202
Enrollment
Unknown
Registered
2025-11-26
Start date
2025-04-07
Completion date
Unknown
Last updated
2025-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes

Interventions

Duel-intensive care group:The study interventions consist of short-term intensive insulin therapy and intensive lifestyle intervention. The insulin therapy focuses on quickly stabilizing blood glucose
Control group:Based on the standard treatment and management recommended by the Chinese Guidelines for Type 2 Diabetes Management.

Sponsors

Xiang Ya Nursing School of Central South University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged between 18 and 70; 2. Meet the diagnostic criteria for T2DM, with HbA1c>=7.5% or FPG>=8 mmol/L, and the course of diabetes <=5 years; 3. Permanent residents of the community who have resided in the community for six months or more and have no intention of moving within the next year; 4. Participate voluntarily and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Previously treated with insulin and having an autoimmune reaction that destroys one's own pancreatic beta cells; 2. Women who are pregnant or breastfeeding; 3. High risk of hypoglycemia; 4. Diagnosed with coronary atherosclerotic cardiovascular disease; 5. Suffering from severe complications of diabetes such as chronic kidney disease and retinopathy, or malignant tumors, etc. 6. People with cognitive impairment, mental disorders, etc., who are unable to communicate normally; 7. There has been alcohol, drug abuse or other circumstances that may reduce research compliance within 3 months; 8. Physical activity is restricted due to other diseases; 9. Patients who do not have an Internet connection when they return home after discharge; 10. Currently participating in other research projects and having interfering effects on this project, etc.

Design outcomes

Primary

MeasureTime frame
Remission Rates;

Secondary

MeasureTime frame
Medication Reduction Rates;Glycated Hemoglobin;Fasting Blood Glucose;Postprandial Blood Glucose;Time in Range;Time Below Range;Time Above Range;Mean Blood Glucose;Body Weight;Body Mass Index;Waist Circumference;Hip Circumference;Waist-to-Hip Ratio;Waist-to-Height Ratio;Body Fat Percentage;Muscle Mass Percentage;Visceral Fat Percentage;Blood Pressure;Triglycerides;Total Cholesterol;Low-Density Lipoprotein Cholesterol;High-Density Lipoprotein Cholesterol;

Countries

China

Contacts

Public ContactMingyue Hu

Xiang Ya Nursing School of Central South University

mingyue.hu@csu.edu.cn+86 731 8883 6044

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026