Study to Assess the Efficacy and Safety of iNCDSS in Type 2 Diabetes Mellitus Patients

Type 2 Diabetes Clinical Trial

— iNCDSS-3  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04642378
• Other study ID #: ZSE-202011
• Status: Completed
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: September 8, 2022

Study information

• Verified date: April 2024
• Source: Shanghai Zhongshan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 149
• Est. completion date: September 8, 2022
• Est. primary completion date: September 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• iNCDSS based insulin regime
Patients of this group will receive the insulin regime set by the AI assisted insulin titration system (iNCDSS).
• routine insulin treatment regime
Patients of this group will receive the insulin regime recommended by professional endocrinologists.

Locations

Country	Name	City	State
China	180 Fenglin Road	Shanghai

Sponsors (3)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital	Shanghai Fifth People's Hospital,Fudan University, XuHui Central Hospital of Shanghai, Shanghai, China

Country where clinical trial is conducted

China, 

References & Publications (11)

Ashrafzadeh S, Hamdy O. Patient-Driven Diabetes Care of the Future in the Technology Era. Cell Metab. 2019 Mar 5;29(3):564-575. doi: 10.1016/j.cmet.2018.09.005. Epub 2018 Sep 27. — View Citation

Bally L, Thabit H, Hartnell S, Andereggen E, Ruan Y, Wilinska ME, Evans ML, Wertli MM, Coll AP, Stettler C, Hovorka R. Closed-Loop Insulin Delivery for Glycemic Control in Noncritical Care. N Engl J Med. 2018 Aug 9;379(6):547-556. doi: 10.1056/NEJMoa1805233. Epub 2018 Jun 25. — View Citation

Davies M, Storms F, Shutler S, Bianchi-Biscay M, Gomis R; ATLANTUS Study Group. Improvement of glycemic control in subjects with poorly controlled type 2 diabetes: comparison of two treatment algorithms using insulin glargine. Diabetes Care. 2005 Jun;28(6):1282-8. doi: 10.2337/diacare.28.6.1282. — View Citation

Harris S, Yale JF, Dempsey E, Gerstein H. Can family physicians help patients initiate basal insulin therapy successfully?: randomized trial of patient-titrated insulin glargine compared with standard oral therapy: lessons for family practice from the Canadian INSIGHT trial. Can Fam Physician. 2008 Apr;54(4):550-8. — View Citation

Ji LN, Lu JM, Guo XH, Yang WY, Weng JP, Jia WP, Zou DJ, Zhou ZG, Yu DM, Liu J, Shan ZY, Yang YZ, Hu RM, Zhu DL, Yang LY, Chen L, Zhao ZG, Li QF, Tian HM, Ji QH, Liu J, Ge JP, Shi LX, Xu YC. Glycemic control among patients in China with type 2 diabetes mellitus receiving oral drugs or injectables. BMC Public Health. 2013 Jun 21;13:602. doi: 10.1186/1471-2458-13-602. — View Citation

Oyer DS, Shepherd MD, Coulter FC, Bhargava A, Brett J, Chu PL, Trippe BS; INITIATEplus Study Group. A(1c) control in a primary care setting: self-titrating an insulin analog pre-mix (INITIATEplus trial). Am J Med. 2009 Nov;122(11):1043-9. doi: 10.1016/j.amjmed.2008.12.026. — View Citation

Rigla M, Garcia-Saez G, Pons B, Hernando ME. Artificial Intelligence Methodologies and Their Application to Diabetes. J Diabetes Sci Technol. 2018 Mar;12(2):303-310. doi: 10.1177/1932296817710475. Epub 2017 May 25. — View Citation

Thabit H, Hartnell S, Allen JM, Lake A, Wilinska ME, Ruan Y, Evans ML, Coll AP, Hovorka R. Closed-loop insulin delivery in inpatients with type 2 diabetes: a randomised, parallel-group trial. Lancet Diabetes Endocrinol. 2017 Feb;5(2):117-124. doi: 10.1016/S2213-8587(16)30280-7. Epub 2016 Nov 9. — View Citation

Wang T, Xu Y, Xu M, Wang W, Bi Y, Lu J, Dai M, Zhang D, Ding L, Xu B, Sun J, Zhao W, Jiang Y, Wang L, Li Y, Zhang M, Lai S, Wang L, Ning G. Awareness, treatment and control of cardiometabolic disorders in Chinese adults with diabetes: a national representative population study. Cardiovasc Diabetol. 2015 Feb 26;14:28. doi: 10.1186/s12933-015-0191-6. — View Citation

Xu Y, Wang L, He J, Bi Y, Li M, Wang T, Wang L, Jiang Y, Dai M, Lu J, Xu M, Li Y, Hu N, Li J, Mi S, Chen CS, Li G, Mu Y, Zhao J, Kong L, Chen J, Lai S, Wang W, Zhao W, Ning G; 2010 China Noncommunicable Disease Surveillance Group. Prevalence and control of diabetes in Chinese adults. JAMA. 2013 Sep 4;310(9):948-59. doi: 10.1001/jama.2013.168118. — View Citation

Yang W, Zhu L, Meng B, Liu Y, Wang W, Ye S, Sun L, Miao H, Guo L, Wang Z, Lv X, Li Q, Ji Q, Zhao W, Yang G. Subject-driven titration of biphasic insulin aspart 30 twice daily is non-inferior to investigator-driven titration in Chinese patients with type 2 diabetes inadequately controlled with premixed human insulin: A randomized, open-label, parallel-group, multicenter trial. J Diabetes Investig. 2016 Jan;7(1):85-93. doi: 10.1111/jdi.12364. Epub 2015 May 25. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time in target glucose range	The well-controlled blood glucose level is defined as the time of sensor glucose measurements in targeted range (3.9-10 mmol/L)	During 5-day intervention
Secondary	Proportion of time in which the blood glucose level is over 10 mmol/L	The poor control of blood glucose level is defined as greater than 10 mmol/L	During 5-day intervention
Secondary	Proportion of hypoglycemia	The hypoglycemia is defined as blood glucose level less than 3.0mmol/L	During 5-day intervention
Secondary	Daily insulin dose	The daily insulin dose is defined as daily total insulin dose	During 5-day intervention