Effect of Real-time Continuous Glucose Monitoring System in Overweight or Obese Adults With Prediabetes
NCT ID: NCT04099550
Last Updated: 2020-04-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2019-12-06
2021-12-31
Brief Summary
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The purpose of this study was to evaluate the effects of real time-continuous glucose measurement (RT-CGM) system compared to only lifestyle modification group on blood glucose, lipid profile and diabetes prevention in prediabetic adults with overweight or obesity.
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Detailed Description
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Thirty adult with overweight or obesity and pre-diabetes are randomised to using either RT-CGM or self monitoring of blood glucose (SMBG) for 1 week with lifestyle intervention.
After 3 month, outcomes were glycemic control (HbA1c, fasting glucose), weight, and lipid profile assessed pre- and post-intervention.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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SMBG with lifestyle intervention
All participants receive a 12-week lifestyle intervention (diet and exercise). The control group was monitored self-monitoring blood glucose (SMBG) at least 2 times a day for initial 1-week.
SMBG
The group was monitored self-monitoring blood glucose (SMBG) at least 2 times a day for initial 1-week.
RT-CGM with lifestyle intervention
All participants receive a 12-week lifestyle intervention (diet and exercise). The intervention group was monitored initial 1-week with a RT-CGM.
RT-CGM
The group was monitored blood glucose initial 1-week with a RT-CGM.
Interventions
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RT-CGM
The group was monitored blood glucose initial 1-week with a RT-CGM.
SMBG
The group was monitored self-monitoring blood glucose (SMBG) at least 2 times a day for initial 1-week.
Eligibility Criteria
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Inclusion Criteria
* impaired fasting glucose (fasting glucose 100 to 125 mg/dL) or impaired glucose tolerance (2-h plasma glucose during oral glucose tolerance test (OGTT) 140 - 199 mg/dl) or HbA1c 5.7% to 6.4%
Exclusion Criteria
* clinical history including malignancy
* fast history of cardiovascular disease (e.g. myocardial infarction, stroke), surgery, and trauma which may affect blood glucose within last 6 months
* taking medication (e.g. glucocorticoid, antipsychotics, anticholinergic drug etc.) which affect blood glucose
* acute infection within last 1 month
* pregnancy
18 Years
ALL
Yes
Sponsors
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Pusan National University Hospital
OTHER
Responsible Party
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JEONG MI KIM
Assistant Professor
Principal Investigators
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JEONG MI KIM, M.D
Role: PRINCIPAL_INVESTIGATOR
Pusan National University Hospital
Locations
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Jeong Mi Kim
Busan, , South Korea
Countries
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Central Contacts
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Facility Contacts
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References
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Gehlaut RR, Dogbey GY, Schwartz FL, Marling CR, Shubrook JH. Hypoglycemia in Type 2 Diabetes--More Common Than You Think: A Continuous Glucose Monitoring Study. J Diabetes Sci Technol. 2015 Apr 27;9(5):999-1005. doi: 10.1177/1932296815581052.
Murphy HR, Rayman G, Lewis K, Kelly S, Johal B, Duffield K, Fowler D, Campbell PJ, Temple RC. Effectiveness of continuous glucose monitoring in pregnant women with diabetes: randomised clinical trial. BMJ. 2008 Sep 25;337:a1680. doi: 10.1136/bmj.a1680.
Tanenberg R, Bode B, Lane W, Levetan C, Mestman J, Harmel AP, Tobian J, Gross T, Mastrototaro J. Use of the Continuous Glucose Monitoring System to guide therapy in patients with insulin-treated diabetes: a randomized controlled trial. Mayo Clin Proc. 2004 Dec;79(12):1521-6. doi: 10.4065/79.12.1521.
Chase HP, Kim LM, Owen SL, MacKenzie TA, Klingensmith GJ, Murtfeldt R, Garg SK. Continuous subcutaneous glucose monitoring in children with type 1 diabetes. Pediatrics. 2001 Feb;107(2):222-6. doi: 10.1542/peds.107.2.222.
Boland E, Monsod T, Delucia M, Brandt CA, Fernando S, Tamborlane WV. Limitations of conventional methods of self-monitoring of blood glucose: lessons learned from 3 days of continuous glucose sensing in pediatric patients with type 1 diabetes. Diabetes Care. 2001 Nov;24(11):1858-62. doi: 10.2337/diacare.24.11.1858.
Salkind SJ, Huizenga R, Fonda SJ, Walker MS, Vigersky RA. Glycemic variability in nondiabetic morbidly obese persons: results of an observational study and review of the literature. J Diabetes Sci Technol. 2014 Sep;8(5):1042-7. doi: 10.1177/1932296814537039. Epub 2014 May 29.
Dagogo-Jack S, Egbuonu N, Edeoga C. Principles and practice of nonpharmacological interventions to reduce cardiometabolic risk. Med Princ Pract. 2010;19(3):167-75. doi: 10.1159/000285280. Epub 2010 Mar 29.
Hedayati SS, Elsayed EF, Reilly RF. Non-pharmacological aspects of blood pressure management: what are the data? Kidney Int. 2011 May;79(10):1061-70. doi: 10.1038/ki.2011.46. Epub 2011 Mar 9.
Lindstrom J, Peltonen M, Eriksson JG, Ilanne-Parikka P, Aunola S, Keinanen-Kiukaanniemi S, Uusitupa M, Tuomilehto J; Finnish Diabetes Prevention Study (DPS). Improved lifestyle and decreased diabetes risk over 13 years: long-term follow-up of the randomised Finnish Diabetes Prevention Study (DPS). Diabetologia. 2013 Feb;56(2):284-93. doi: 10.1007/s00125-012-2752-5. Epub 2012 Oct 24.
Marquez-Celedonio FG, Texon-Fernandez O, Chavez-Negrete A, Hernandez-Lopez S, Marin-Rendon S, Berlin-Lascurain S. [Clinical effect of lifestyle modification on cardiovascular risk in prehypertensives: PREHIPER I study]. Rev Esp Cardiol. 2009 Jan;62(1):86-90. Spanish.
Yoon U, Kwok LL, Magkidis A. Efficacy of lifestyle interventions in reducing diabetes incidence in patients with impaired glucose tolerance: a systematic review of randomized controlled trials. Metabolism. 2013 Feb;62(2):303-14. doi: 10.1016/j.metabol.2012.07.009. Epub 2012 Sep 7.
Rosenberg K. Prediabetes Increases Risk of Cardiovascular Disease. Am J Nurs. 2017 Jun;117(6):71. doi: 10.1097/01.NAJ.0000520262.18448.1c. No abstract available.
Mayer-Davis EJ, Lawrence JM, Dabelea D, Divers J, Isom S, Dolan L, Imperatore G, Linder B, Marcovina S, Pettitt DJ, Pihoker C, Saydah S, Wagenknecht L; SEARCH for Diabetes in Youth Study. Incidence Trends of Type 1 and Type 2 Diabetes among Youths, 2002-2012. N Engl J Med. 2017 Apr 13;376(15):1419-1429. doi: 10.1056/NEJMoa1610187.
Other Identifiers
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PNUHEnMJMK1
Identifier Type: -
Identifier Source: org_study_id
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