Optic IconOptic Logo
|
SearchCollectionsBenchmarks
Clinical trial

Study to Assess the Efficacy and Safety of iNCDSS Assisted Insulin Dosage Titration System on Glucose Control in Type 2 Diabetes Mellitus Patients : a Muticenter, Single-blind, Randomized Controlled Study

ID
Name
ZSE-202011
Description
This is a multi-center, single-blind, parallel group, randomized controlled trial to access the effect and safety of the Artificial Intelligence Assisted Insulin Titration System (iNCDSS) in patients with Type 2 Diabetes Mellitus.
Trial arms
Trial start
2021-10-01
Estimated PCD
2022-09-08
Trial end
2022-09-08
Status
Completed
Treatment
iNCDSS based insulin regime
Patients of this group will receive the insulin regime set by the AI assisted insulin titration system (iNCDSS).
Arms:
iNCDSS group
routine insulin treatment regime
Patients of this group will receive the insulin regime recommended by professional endocrinologists.
Arms:
Routine treatment group
Size
149
Primary endpoint
Time in target glucose range
During 5-day intervention
Eligibility criteria
Inclusion Criteria: * Men or women aged 18 and above years old; * Subjects who had been diagnosed with type 2 diabetes; * Subjects who are on diabetes treatment for at least 3 months; * HbA1c: 7.0%-11.0%. Exclusion Criteria: * 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The intervention group will receive iNCDSS assisted recommendation for insulin dose titration. The control group will receive insulin dose titrated by senior attending physicians.', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 149, 'type': 'ACTUAL'}}
Updated at
2024-04-16

1 organization

2 products

1 indication

Organization
Shanghai Zhongshan Hospital
Product
iNCDSS based insulin regime
Indication
Type 2 Diabetes
Product
Insulin