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Efficacy and Safety Analysis of Practice Management Support Strategies of Once-weekly Insulin Icodec under the "in-person remote" Diabetes Self-Management Support Model: A Pragmatic Randomized Controlled Trial

Efficacy and Safety Analysis of Practice Management Support Strategies of Once-weekly Insulin Icodec under the "in-person remote" Diabetes Self-Management Support Model: A Pragmatic Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500097413
Enrollment
Unknown
Registered
2025-02-19
Start date
2025-03-01
Completion date
Unknown
Last updated
2025-02-24

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

Conditions

Type 2 diabetes

Interventions

Traditional Dose Titration Assistance Support Group:Patients receiving traditional dose titration assistance support management under a remote care system for Once-weekly Insulin Icodec
Artificial Intelligence-Assisted Weekly Dose Titration Digital Therapy Group:Patients receiving management with artificial intelligence-assisted Once-weekly Insulin Icodec dose titration Digital Thera

Sponsors

Peking University First Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Patients who were newly registered in the Diabetes Shared Care Management cohort of Peking University First Hospital from October 2016 to February 2025; 2. Patients with type 2 diabetes mellitus; 3. Age>=18 years old, and age =7% and < 10%; 5. Patients with poor control of oral medication, who need to start basal insulin therapy and are willing to use insulin preparations, or patients who have used premixed insulin/dual insulin/basal insulin therapy and are willing to switch to insulin preparations. 6. Agree to participate and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients who withdraw from the diabetes shared care outpatient management cohort by February 2025 for various reasons; 2. Pre-diabetes, type 1 diabetes, special type of diabetes and other non-type 2 diabetes; 3. Patients with any of the following medical and surgical histories: a. Uncontrolled hypertension, with mean sitting systolic blood pressure (SBP)>=170mmHg or mean sitting diastolic blood pressure (DBP)>=110 mmHg at the initial visit or mean sitting systolic blood pressure >=160mmHg or mean sitting DBP>=100mmHg at the follow-up visit c. Clinical diagnosis of chronic heart failure with reduced ejection fraction with persistent symptoms e. Stroke, transient ischemic attack, acute coronary syndrome, or hospitalization for worsening heart failure within 30 days before enrollment f. Dialysis due to acute renal failure <=12 weeks before enrollment/kidney transplantation/planned kidney transplantation within the next six months G. Addison's disease h. Hepatic insufficiency, Child-Pugh type C i. Allergy to the active ingredient or any excipients 4. Patients with any of the following: a Any other medical condition or treatment that would make the patient ineligible for the study and would not allow participation for the entire planned study period (e.g., malignancy, vital organ failure, or other medical condition that limits life expectancy to less than 12 months). b. Pregnancy, lactation, or intention to become pregnant during the study period c. Prior (<=30 days before randomization) or concurrent participation in another clinical study with the investigational drug d. Patients with communication disorders who are unable to fully understand or cooperate.

Design outcomes

Primary

MeasureTime frame
HbA1c;

Secondary

MeasureTime frame
Hypoglycemia level 2;Hypoglycemia level 3;

Countries

China

Contacts

Public ContactLi Ang

Peking University First Hospital

liang850513@hotmail.com+86 136 8133 8795

Outcome results

None listed

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