Clinical trial NCT04642378: Study to Assess the Efficacy and Safety of iNCDSS in Type 2 Diabetes Mellitus Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: iNCDSS
T2D
AI
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
Collaborators: name: Fudan University
name: XuHui Central Hospital of Shanghai, Shanghai, China
First posted: 2020-11-24
Enrollment: 149
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The intervention group will receive iNCDSS assisted recommendation for insulin dose titration. The control group will receive insulin dose titrated by senior attending physicians.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: As one of the most common treatments for diabetes inpatients, insulin regimens often vary due to different physicians. Since 2016, Zhongshan Hospital has set up the Internet-based glucose management system (iGMS) to monitor plasma glucose of diabetes patients, and further set up an Artificial Intelligence Assisted Insulin Titration System (iNCDSS) to recommend insulin regime in 2019. Previous single-center clinical trial (NCT04053959) have indicated the efficacy and safety of iNCDSS in glycemic management in patients with type 2 diabetes.

This multi-center study enrolls 142 patients with Type 2 Diabetes from three sites who are on treatment of diabetes for at least 3 months. They will be randomly allocated into 2 groups at a ratio of 1:1 after screening for the inclusion and exclusion criteria. Patients in the Intervention group (iNCDSS group) receive insulin regimen set by iNCDSS and patients in Regular treatment regime group receive insulin regimen recommended by endocrinologists.

This study will be conducted in the Department of Endocrinology in Shanghai Zhongshan Hospital, Shanghai fifth People's Hospital, Shanghai Xuhui Central Hospital, and will consist of a 5-day intervention period. Patient allocation will be stratified by HbA1c and sites. The primary endpoint is the time in target glucose range during the trial period.

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.

Primary outcomes:
measure: Time in target glucose range
timeFrame: During 5-day intervention
Secondary outcomes:
measure: Proportion of time in which the blood glucose level is over 10 mmol/L
timeFrame: During 5-day intervention
measure: Proportion of hypoglycemia
timeFrame: During 5-day intervention
measure: Daily insulin dose
timeFrame: During 5-day intervention
Other outcomes:
Locations:
city: Shanghai
country: China
facility: 180 Fenglin Road
Study officials:
affiliation: Shanghai Zhongshan Hospital
name: Xiaoying Li, MD
role: PRINCIPAL_INVESTIGATOR
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