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

NCT04642378 | Completed

• 1 other identifier: ZSE-202011
• Study Type: interventional
• Target: 149
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Keywords

iNCDSS; T2D; AI

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Proportion of time in which the blood glucose level is over 10 mmol/L

  During 5-day intervention

• Proportion of hypoglycemia

  During 5-day intervention

• Daily insulin dose

  During 5-day intervention

Study Arms (2)

iNCDSS group

EXPERIMENTAL

Artificial intelligence assisted insulin titration system group

Drug: iNCDSS based insulin regime

Routine treatment group

ACTIVE COMPARATOR

Physician decided insulin titration group

Drug: routine insulin treatment regime

Interventions

iNCDSS based insulin regime DRUG

Patients of this group will receive the insulin regime set by the AI assisted insulin titration system (iNCDSS).

iNCDSS group

routine insulin treatment regime DRUG

Patients of this group will receive the insulin regime recommended by professional endocrinologists.

Routine treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead
• Fudan University: collaborator
• XuHui Central Hospital of Shanghai, Shanghai, China: collaborator

Study Sites (1)

180 Fenglin Road

Shanghai, 200032, China

Location

Related Publications (12)

• 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.

  PMID: 24002281 BACKGROUND

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  PMID: 25848699 BACKGROUND

• 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.

  PMID: 23800082 BACKGROUND

• 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.

  PMID: 15920040 BACKGROUND

• 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.

  PMID: 19854333 BACKGROUND

• 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.

  PMID: 26816605 BACKGROUND

• 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.

  PMID: 18411384 BACKGROUND

• 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.

  PMID: 28539087 BACKGROUND

• 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.

  PMID: 30269984 BACKGROUND

• 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.

  PMID: 27836235 BACKGROUND

• 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.

  PMID: 29940126 BACKGROUND

• Ying Z, Fan Y, Chen C, Liu Y, Tang Q, Chen Z, Yang Q, Yan H, Wu L, Lu J, Liu Z, Liu J, Li X, Chen Y. Real-Time AI-Assisted Insulin Titration System for Glucose Control in Patients With Type 2 Diabetes: A Randomized Clinical Trial. JAMA Netw Open. 2025 May 1;8(5):e258910. doi: 10.1001/jamanetworkopen.2025.8910.

  PMID: 40332936 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Xiaoying Li, MD

  Shanghai Zhongshan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Model Details: The intervention group will receive iNCDSS assisted recommendation for insulin dose titration. The control group will receive insulin dose titrated by senior attending physicians.

Study Record Dates

• First Submitted: November 22, 2020
• First Posted: November 24, 2020
• Study Start: October 1, 2021
• Primary Completion: September 8, 2022
• Study Completion: September 8, 2022
• Last Updated: April 16, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)