Status:
COMPLETED
Artificial Intelligence Assisted Insulin Titration System
Lead Sponsor:
Shanghai Zhongshan Hospital
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
This is a single-center, open-labeled, parallel group, randomized controlled trial to access the effect and safety of the Artificial Intelligence Assisted Insulin Titration System in patients with Typ...
Detailed Description
The study enrolls 44 patients with Type 2 Diabetes in Zhongshan Hospital who are on treatment with insulin for at least 3 months. They are randomly allocated into 2 groups at a ratio of 1:1 after scre...
Eligibility Criteria
Inclusion
- Men or women aged 18-75 years old;
- Subjects who had been diagnosed with type 2 diabetes;
- Subjects who are on treatment with insulin for at least 3 months;
- HbA1c: 7.0%-11.0%.
Exclusion
- Subjects with acute complications of diabetes such as ketoacidosis or hyperglycemic hyperosmolar state;
- Subjects who change the insulin regimens during hospitalization;
- BMI ≥ 45kg/m2;
- Women who are pregnant or nursing;
- Subjects with severe cardiac, hepatic, renal or general diseases;
- Subjects with psychiatric disorders or impaired cognitive function;
- Subjects with severe edema, infections or peripheral circulation disorders;
- Patients treated with surgery during hospitalization;
- Subjects that are, in the judgement of the investigator, unlikely to comply with the protocol.
Key Trial Info
Start Date :
September 27 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 15 2020
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT04053959
Start Date
September 27 2019
End Date
April 15 2020
Last Update
July 27 2020
Active Locations (1)
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1
180 Fenglin Road
Shanghai, China, 200032