PreDiabetesNCT04369833
Development of Continuous Glucose Monitoring System Cohort for Personalized Diabetes Prevention and Management Platform
An observational study of PreDiabetes and Glucose Metabolism Disorders, run by Pusan National University Hospital at 1 site in South Korea.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PreDiabetes, Glucose Metabolism Disorders, Diabetes Mellitus
- What is being tested?
- continuous glucose monitoring system
- Type of treatment
- Medical device
- How many people
- 130 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 May 2020to 30 Sep 2020
- How long will I take part?
- 7 Days
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Above 18 years old.
- Prediabetes
- Fasting plasma glucose : 100~125mg/dL, fasting is defined as no caloric intake for at least 8 hours.
- OR
- 2-hour plasma glucose during 75g oral glucose tolerance test : 140 ~ 199mg/dL
- OR
- Glycated hemoglobin(HbA1c) : 5.7~6.4% (39-47mmol/mol)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of Continuous Glucose Monitoring System Cohort for Personalized Diabetes Prevention and Management Platform Based on Artificial Intelligence Model Using Mathematical Analysis
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.
Read the detailed 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.
- Conditions
- PreDiabetes, Glucose Metabolism Disorders, Diabetes Mellitus
- Being tested
- continuous glucose monitoring system
- Medical subject headings
- Prediabetic State, Glucose Metabolism Disorders, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
continuous glucose monitoring systemDevice
wearing continuous glucose monitoring device (iPro2 professional continuous glucose monitoring, MedtronicⓇ, California, USA)
| Study group | Role | What they receive |
|---|---|---|
| continuous glucose monitoring group | all participants wearing a continuous glucose monitoring device Receives: Device: continuous glucose monitoring system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2020
- Study start11 May 2020
- Primary completion30 Sep 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for PreDiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 participants (actual)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Pusan National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sang soo Kim, Master, Principal investigator, Pusan National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04369833
- Sponsor's protocol ID
- H-2003-033-088
- Status last verified
- Feb 2022
- First submitted
- 27 Apr 2020
- Last updated
- 9 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data are not publicly available due to privacy or ethical restrictions.
Publications
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.
PubMed 18508669Hansen 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.
PubMed 7037815Lang 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.
PubMed 386121Mendes-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.
PubMed 30735238Kim 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.
PubMed 31339012Ha 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.
PubMed 30113144Lee 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.
PubMed 22688547Zeevi 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.
PubMed 26590418Shapiro 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.
PubMed 3292558Kraegen 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.
PubMed 4655495Simon 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.
PubMed 3102544
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Continuous Glucose Monitoring System Cohort for Personalized Diabetes Prevention and Management Platform Based on Artificial Intelligence Model Using Mathematical Analysis
- ClinicalTrials.gov ID
- NCT04369833
- Acronym / sponsor ID
- H-2003-033-088
- Conditions
- PreDiabetes, Glucose Metabolism Disorders, Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Pusan National University HospitalUniversity, hospital or other
- Study start
- 11 May 2020 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 30 Apr 2020 (actual)
- Results
- Posted 9 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| continuous glucose monitoring group | – | Device: continuous glucose monitoring systemall participants wearing a continuous glucose monitoring device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (7 listed)
- Above 18 years old.
- Prediabetes
- OR
- OR
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| continuous glucose monitoring systemwearing continuous glucose monitoring device (iPro2 professional continuous glucose monitoring, MedtronicⓇ, California, USA) | Device | continuous glucose monitoring group |
Primary outcome
Number of Participants With Insulin Resistance
Time frame: 1 week
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18508669Kang 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.
- Background: PubMed 7037815Hansen 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.
- Background: PubMed 386121Lang 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.
- Background: PubMed 30735238Mendes-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.
- Background: PubMed 31339012Kim 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.
- Background: PubMed 30113144Ha 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.
- Background: PubMed 22688547Lee 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.
- Background: PubMed 26590418Zeevi 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.
- Background: PubMed 3292558Shapiro 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.
- Background: PubMed 4655495Kraegen 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.
- Background: PubMed 3102544Simon 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.
- Individual participant dataSharing planned: No. The data are not publicly available due to privacy or ethical restrictions.
Related trials for PreDiabetes
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
RecruitingObservational study
Food-i-Sense Analytics: Integrating AI Into Continuous Glucose Monitoring Data Analysis for Precision Nutrition.
Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Artificial Intelligence Mobile Application
RecruitingPhase 3
A Study of Orforglipron in Participants With Overweight at Risk of Development of Obesity-Related Complications or Progression to Class 1 Obesity
Overweight, Prediabetic State
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Recruiting
CGM-Enhanced DPP to Prevent Type 2 Diabetes in Adults With Prediabetes
PreDiabetes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sang soo Kim, Master principal investigator
Pusan National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PreDiabetes and Glucose Metabolism Disorders, run by Pusan National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Insulin Resistance (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04369833, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2022.