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

NCT04369833 | Completed Results

• 1 other identifier: H-2003-033-088
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

PreDiabetes; Glucose Metabolism Disorders; Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

continuous glucose monitoring group

all participants wearing a continuous glucose monitoring device

Device: continuous glucose monitoring system

Interventions

continuous glucose monitoring system DEVICE

wearing continuous glucose monitoring device (iPro2 professional continuous glucose monitoring, MedtronicⓇ, California, USA)

continuous glucose monitoring group

Eligibility Criteria

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

Study Population

Subjects of pre-diabetes who visited the Department of Internal Medicine and division of Endodrinology \& Metabolism and the Health Examination Center, Pusan National University Hospital

You may qualify if:

• Above 18 years old.
• Prediabetes
• Fasting plasma glucose : 100\~125mg/dL, fasting is defined as no caloric intake for at least 8 hours.
• hour plasma glucose during 75g oral glucose tolerance test : 140 \~ 199mg/dL
• Glycated hemoglobin(HbA1c) : 5.7\~6.4% (39-47mmol/mol)

You may not qualify if:

• 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

Sponsors & Collaborators

• Pusan National University Hospital: lead

Study Sites (1)

Pusan national university hospital

Busan, 49241, South Korea

Location

Related Publications (11)

• 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. doi: 10.2741/3163.

  PMID: 18508669 BACKGROUND

• 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. doi: 10.1210/jcem-54-4-785.

  PMID: 7037815 BACKGROUND

• 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. doi: 10.1056/NEJM197911083011903.

  PMID: 386121 BACKGROUND

• 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.

  PMID: 30735238 BACKGROUND

• 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.

  PMID: 31339012 BACKGROUND

• 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.

  PMID: 30113144 BACKGROUND

• 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.

  PMID: 22688547 BACKGROUND

• 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, Dohnalova 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.

  PMID: 26590418 BACKGROUND

• 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. doi: 10.1210/jcem-67-2-307.

  PMID: 3292558 BACKGROUND

• 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. doi: 10.1055/s-0028-1094019. No abstract available.

  PMID: 4655495 BACKGROUND

• 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. doi: 10.1210/jcem-64-4-669.

  PMID: 3102544 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood sample (for HbA1c, Total cholesterol, LDL-C, HDL-C, Triglyceride, aspartate aminotransferase, alanine aminotransferase, Creatinine, free fatty acid etc), Feces (for evaluating microbiomes)

MeSH Terms

Conditions

Prediabetic State; Glucose Metabolism Disorders; Diabetes Mellitus

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Results Point of Contact

• Title: Dr. Sang Soo Kim
• Organization: Pusan national university hospital

drsskim7@gmail.com

+82-51-240-7837

Study Officials

• Sang soo Kim, Master

  Pusan National University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2020
• First Posted: April 30, 2020
• Study Start: May 11, 2020
• Primary Completion: September 30, 2020
• Study Completion: September 30, 2020
• Last Updated: May 9, 2022
• Results First Posted: May 9, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)