Development of Continuous Glucose Monitoring System Cohort for Personalized Diabetes Prevention and Management Platform
NCT ID: NCT04369833
Last Updated: 2022-05-09
Study Results
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View full resultsBasic Information
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COMPLETED
130 participants
OBSERVATIONAL
2020-05-11
2020-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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continuous glucose monitoring group
all participants wearing a continuous glucose monitoring device
continuous glucose monitoring system
wearing continuous glucose monitoring device (iPro2 professional continuous glucose monitoring, MedtronicⓇ, California, USA)
Interventions
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continuous glucose monitoring system
wearing continuous glucose monitoring device (iPro2 professional continuous glucose monitoring, MedtronicⓇ, California, USA)
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Pusan National University Hospital
OTHER
Responsible Party
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Principal Investigators
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Sang soo Kim, Master
Role: PRINCIPAL_INVESTIGATOR
Pusan National University Hospital
Locations
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Pusan national university hospital
Busan, , South Korea
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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H-2003-033-088
Identifier Type: -
Identifier Source: org_study_id
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