Development of Continuous Glucose Monitoring System Cohort for Personalized Diabetes Prevention and Management Platform

Diabetes Mellitus Clinical Trial

Official title:

Development of Continuous Glucose Monitoring System Cohort for Personalized Diabetes Prevention and Management Platform Based on Artificial Intelligence Model Using Mathematical Analysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04369833
• Other study ID #: H-2003-033-088
• Status: Completed
• Start date: May 11, 2020
• Est. completion date: September 30, 2020

Study information

• Verified date: February 2022
• Source: Pusan National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The purpose of this study is to collect a variety of clinical data and blood glucose changes using a continuous glucose monitoring device for high-risk diabetes patients (prediabetes) in order to develop a personalized diabetes prevention and management platform based on artificial intelligence model using mathematical analysis.

Description:

After being informed about the study and potential risks, all patients giving written informed consent wear a continuous glucose monitoring device ("iPro2" professional continuous glucose monitoring, MedtronicⓇ, California, USA) and smart band ("Fitbit Inspire HR", FitbitⓇ, California, USA) for 1 week. During this period, all patients are tested oral glucose tolerance test and take a standard diet (calorie calculated) at morning. The patient's data from this study is compared to a predicted values by mathematical analysis model for diabetes prevention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: September 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Above 18 years old.
• Prediabetes

1. Fasting plasma glucose : 100~125mg/dL, fasting is defined as no caloric intake for at least 8 hours. OR

2. 2-hour plasma glucose during 75g oral glucose tolerance test : 140 ~ 199mg/dL OR

3. Glycated hemoglobin(HbA1c) : 5.7~6.4% (39-47mmol/mol)

Exclusion Criteria:

• with a history of newly diagnosed and treated cancer within the last 5 years
• with a history of hospitalization for active disease within the last 3 months
• with a history of severe cardiovascular disease within the last 3 months
• with a history of steroid treatment in the last 3 months
• people who have had major surgery planned within the last 3 months or who have had surgery within 3 months
• people who are pregnant or have been in the last 3 months after giving birth

Related Conditions & MeSH terms

• Diabetes Mellitus
• Glucose Metabolism Disorders
• Metabolic Diseases
• PreDiabetes

Intervention

Device:
• continuous glucose monitoring system
wearing continuous glucose monitoring device (iPro2 professional continuous glucose monitoring, Medtronic?, California, USA)

Locations

Country	Name	City	State
Korea, Republic of	Pusan national university hospital	Busan

Sponsors (1)

Lead Sponsor	Collaborator
Pusan National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (11)

Ha KH, Lee YH, Song SO, Lee JW, Kim DW, Cho KH, Kim DJ. Development and Validation of the Korean Diabetes Risk Score: A 10-Year National Cohort Study. Diabetes Metab J. 2018 Oct;42(5):402-414. doi: 10.4093/dmj.2018.0014. Epub 2018 Jul 6. — View Citation

Hansen BC, Jen KC, Belbez Pek S, Wolfe RA. Rapid oscillations in plasma insulin, glucagon, and glucose in obese and normal weight humans. J Clin Endocrinol Metab. 1982 Apr;54(4):785-92. — View Citation

Kang H, Han K, Jo J, Kim J, Choi MY. Systems of pancreatic beta-cells and glucose regulation. Front Biosci. 2008 May 1;13:6421-31. Review. — View Citation

Kim BY, Won JC, Lee JH, Kim HS, Park JH, Ha KH, Won KC, Kim DJ, Park KS. Diabetes Fact Sheets in Korea, 2018: An Appraisal of Current Status. Diabetes Metab J. 2019 Aug;43(4):487-494. doi: 10.4093/dmj.2019.0067. Epub 2019 Jul 17. — View Citation

Kraegen EW, Young JD, George EP, Lazarus L. Oscillations in blood glucose and insulin after oral glucose. Horm Metab Res. 1972 Nov;4(6):409-13. — View Citation

Lang DA, Matthews DR, Peto J, Turner RC. Cyclic oscillations of basal plasma glucose and insulin concentrations in human beings. N Engl J Med. 1979 Nov 8;301(19):1023-7. — View Citation

Lee YH, Bang H, Kim HC, Kim HM, Park SW, Kim DJ. A simple screening score for diabetes for the Korean population: development, validation, and comparison with other scores. Diabetes Care. 2012 Aug;35(8):1723-30. doi: 10.2337/dc11-2347. Epub 2012 Jun 11. — View Citation

Mendes-Soares H, Raveh-Sadka T, Azulay S, Edens K, Ben-Shlomo Y, Cohen Y, Ofek T, Bachrach D, Stevens J, Colibaseanu D, Segal L, Kashyap P, Nelson H. Assessment of a Personalized Approach to Predicting Postprandial Glycemic Responses to Food Among Individuals Without Diabetes. JAMA Netw Open. 2019 Feb 1;2(2):e188102. doi: 10.1001/jamanetworkopen.2018.8102. — View Citation

Shapiro ET, Tillil H, Polonsky KS, Fang VS, Rubenstein AH, Van Cauter E. Oscillations in insulin secretion during constant glucose infusion in normal man: relationship to changes in plasma glucose. J Clin Endocrinol Metab. 1988 Aug;67(2):307-14. — View Citation

Simon C, Brandenberger G, Follenius M. Ultradian oscillations of plasma glucose, insulin, and C-peptide in man during continuous enteral nutrition. J Clin Endocrinol Metab. 1987 Apr;64(4):669-74. — View Citation

Zeevi D, Korem T, Zmora N, Israeli D, Rothschild D, Weinberger A, Ben-Yacov O, Lador D, Avnit-Sagi T, Lotan-Pompan M, Suez J, Mahdi JA, Matot E, Malka G, Kosower N, Rein M, Zilberman-Schapira G, Dohnalová L, Pevsner-Fischer M, Bikovsky R, Halpern Z, Elinav E, Segal E. Personalized Nutrition by Prediction of Glycemic Responses. Cell. 2015 Nov 19;163(5):1079-1094. doi: 10.1016/j.cell.2015.11.001. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Insulin Resistance	the prevalence of insulin resistance in participants was measured. Insulin resistance was calculated by HOMA-IR(homeostatic model assessment of insulin resistance), QUICKI (quantitative insulin sensitivity check index) and Matsuda index	1 week