Effect of Real-time Continuous Glucose Monitoring System in Overweight or Obese Adults With Prediabetes

NCT04099550 | Unknown

• 1 other identifier: PNUHEnMJMK1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

In Korea, 5 million adults aged 30 years or older have diabetes. The development and expansion of Korea's economy and society, has led to dramatic chances in people's lifestyle and diet habits, and an increase in life expectancy. However, changes in lifestyle and diet habits related to the improvements of socioeconomic status may contribute to an increased diabetes burden in Korea. Therefore, it is important to prevent diabetes. 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.

Conditions

Continuous Glucose Monitoring; Prediabetic State; Obesity

Outcome Measures

Primary Outcomes (2)

• HbA1C change

  All participants receive lifestyle intervention at week 0, week 4, and week 8. The intervention group was monitored initial 1 weeks with a RT-CGM and th control group continued self-monitoring blood glucose (SMBG) at least 2 times a day for 1 week. HbA1c at baseline (week 0) and end of intervention (week 12).

  Outcomes were assessed at baseline (week 0) and end of intervention (week 12)

• Weight (Kg) change

  weight change (Kg) at baseline (week 0) and end of intervention (week 12)

  baseline (week 0) and end of intervention (week 12)

Secondary Outcomes (1)

• lipid profile

  baseline (week 0) and end of intervention (week 12)

Study Arms (2)

SMBG with lifestyle intervention

ACTIVE COMPARATOR

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.

Other: SMBG

RT-CGM with lifestyle intervention

EXPERIMENTAL

All participants receive a 12-week lifestyle intervention (diet and exercise). The intervention group was monitored initial 1-week with a RT-CGM.

Device: RT-CGM

Interventions

RT-CGM DEVICE

The group was monitored blood glucose initial 1-week with a RT-CGM.

RT-CGM with lifestyle intervention

SMBG OTHER

The group was monitored self-monitoring blood glucose (SMBG) at least 2 times a day for initial 1-week.

SMBG with lifestyle intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ BMI 23 kg/m2
• 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%

You may not qualify if:

• type 1 diabetes or type 2 diabetes or undergoing treatment for diabetes
• 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

Sponsors & Collaborators

• Pusan National University Hospital: lead

Study Sites (1)

Jeong Mi Kim

Busan, 49241, South Korea

RECRUITING

Related Publications (13)

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  PMID: 25917335 BACKGROUND

• 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.

  PMID: 18818254 BACKGROUND

• 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.

  PMID: 15595336 BACKGROUND

• 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.

  PMID: 11158450 BACKGROUND

• 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.

  PMID: 11679447 BACKGROUND

• 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.

  PMID: 24876453 BACKGROUND

• 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.

  PMID: 20357497 BACKGROUND

• 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.

  PMID: 21389976 BACKGROUND

• 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.

  PMID: 23093136 BACKGROUND

• 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.

  PMID: 19150019 BACKGROUND

• 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.

  PMID: 22959500 BACKGROUND

• 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.

  PMID: 28541998 BACKGROUND

• 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.

  PMID: 28402773 BACKGROUND

MeSH Terms

Conditions

Prediabetic State; Obesity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• JEONG MI KIM, M.D

  Pusan National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

JEONG MI KIM, M.D

CONTACT

82-10-9431-3733; marse007@hanmail.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: participants were randomised to undertake a 12-week lifestyle intervention with either RT-CGM or SMBG

Study Record Dates

• First Submitted: September 10, 2019
• First Posted: September 23, 2019
• Study Start: December 6, 2019
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2021
• Last Updated: April 24, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)