Is Real-time CGM Superior to Flash Glucose Monitoring

NCT04358263 | Unknown FDA Device

• 1 other identifier: CORRIDA
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the investigator's study is to compare real-time continuous glucose monitoring and flash glucose monitoring in adult patients with Type 1 Diabetes during 4-day training program focused on physical activity and over 4 weeks of follow-up.

Conditions

Diabetes Mellitus, Type 1

Keywords

Continuous Glucose Monitoring; Flash Glucose Monitoring; Hypoglycemia; Time in Range; Physical Activity

Outcome Measures

Primary Outcomes (1)

• Percentage of time in hypoglycemic ranges

  \<3,9 mmol/L (70 mg/dl) and \<3,0 mmol/L (54 mg/dl)

  Up to 2 months

Secondary Outcomes (7)

• Percentage of time in target ranges

  Up to 2 months

• Percentage of time in hyperglycemic ranges

  Up to 2 months

• Changes in glycemic variability

  Up to 2 months

• Mean sensor glucose concentration

  Up to 2 months

• Changes in quality of life as assessed by validated questionnaire

  Up to 2 months

Study Arms (2)

rtCGM

EXPERIMENTAL

Patients with use of the Guardian Connect Mobile system (real-time continuous glucose monitoring).

Device: Continuous Glucose Monitoring Guardian Connect Mobile system (real-time continuous glucose monitoring)

isCGM

EXPERIMENTAL

Patients with use of the FreeStyle Libre Flash system (intermittently-scanned continuous glucose monitoring).

Device: Continuous Glucose Monitoring FreeStyle Libre Flash system (intermittently-scanned continuous glucose monitoring)

Interventions

Continuous Glucose Monitoring Guardian Connect Mobile system (real-time continuous glucose monitoring) DEVICE

rtCGM and isCGM are used in Type 1 diabetic patients to improve glucose control and to minimize or avoid severe hypoglycaemia.

rtCGM

Continuous Glucose Monitoring FreeStyle Libre Flash system (intermittently-scanned continuous glucose monitoring) DEVICE

rtCGM and isCGM are used in Type 1 diabetic patients to improve glucose control and to minimize or avoid severe hypoglycaemia.

isCGM

Eligibility Criteria

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

You may qualify if:

• patients with T1D naive to rtCGM and isCGM
• Type 1 diabetes for \>2 years
• ≥ 18 years old
• CSII or MDI
• GOLD score \< 4, no history of severe hypoglycemia within last 6 month
• written informed consent prior to starting study related activity

You may not qualify if:

• severe noncompliance
• severe diabetic retinopathy and/or macular edema
• lactation, pregnancy, intending to become pregnant during study
• condition likely to require MRI
• use of acetaminophen-containing medication
• unwillingness to use the study device for \>70% of time

Sponsors & Collaborators

• Charles University, Czech Republic: lead

Study Sites (1)

3rd Department of Internal Medicine, 1st Faculty of Medicine Charles University

Prague, Czech Republic, Czechia

Location

Related Publications (10)

• Cryer PE. Hypoglycemia: still the limiting factor in the glycemic management of diabetes. Endocr Pract. 2008 Sep;14(6):750-6. doi: 10.4158/EP.14.6.750.

  PMID: 18996798 BACKGROUND

• Moser O, Tschakert G, Mueller A, Groeschl W, Pieber TR, Obermayer-Pietsch B, Koehler G, Hofmann P. Effects of High-Intensity Interval Exercise versus Moderate Continuous Exercise on Glucose Homeostasis and Hormone Response in Patients with Type 1 Diabetes Mellitus Using Novel Ultra-Long-Acting Insulin. PLoS One. 2015 Aug 28;10(8):e0136489. doi: 10.1371/journal.pone.0136489. eCollection 2015.

  PMID: 26317981 BACKGROUND

• Cryer PE. Hypoglycemia in type 1 diabetes mellitus. Endocrinol Metab Clin North Am. 2010 Sep;39(3):641-54. doi: 10.1016/j.ecl.2010.05.003.

  PMID: 20723825 BACKGROUND

• Edelman SV, Argento NB, Pettus J, Hirsch IB. Clinical Implications of Real-time and Intermittently Scanned Continuous Glucose Monitoring. Diabetes Care. 2018 Nov;41(11):2265-2274. doi: 10.2337/dc18-1150.

  PMID: 30348844 BACKGROUND

• Beck RW, Riddlesworth T, Ruedy K, Ahmann A, Bergenstal R, Haller S, Kollman C, Kruger D, McGill JB, Polonsky W, Toschi E, Wolpert H, Price D; DIAMOND Study Group. Effect of Continuous Glucose Monitoring on Glycemic Control in Adults With Type 1 Diabetes Using Insulin Injections: The DIAMOND Randomized Clinical Trial. JAMA. 2017 Jan 24;317(4):371-378. doi: 10.1001/jama.2016.19975.

  PMID: 28118453 BACKGROUND

• Soupal J, Petruzelkova L, Flekac M, Pelcl T, Matoulek M, Dankova M, Skrha J, Svacina S, Prazny M. Comparison of Different Treatment Modalities for Type 1 Diabetes, Including Sensor-Augmented Insulin Regimens, in 52 Weeks of Follow-Up: A COMISAIR Study. Diabetes Technol Ther. 2016 Sep;18(9):532-8. doi: 10.1089/dia.2016.0171. Epub 2016 Aug 2.

  PMID: 27482825 BACKGROUND

• Soupal J, Petruzelkova L, Grunberger G, Haskova A, Flekac M, Matoulek M, Mikes O, Pelcl T, Skrha J Jr, Horova E, Skrha J, Parkin CG, Svacina S, Prazny M. Glycemic Outcomes in Adults With T1D Are Impacted More by Continuous Glucose Monitoring Than by Insulin Delivery Method: 3 Years of Follow-Up From the COMISAIR Study. Diabetes Care. 2020 Jan;43(1):37-43. doi: 10.2337/dc19-0888. Epub 2019 Sep 17.

  PMID: 31530663 BACKGROUND

• Oskarsson P, Antuna R, Geelhoed-Duijvestijn P, Krӧger J, Weitgasser R, Bolinder J. Impact of flash glucose monitoring on hypoglycaemia in adults with type 1 diabetes managed with multiple daily injection therapy: a pre-specified subgroup analysis of the IMPACT randomised controlled trial. Diabetologia. 2018 Mar;61(3):539-550. doi: 10.1007/s00125-017-4527-5. Epub 2017 Dec 23.

  PMID: 29273897 BACKGROUND

• Reddy M, Jugnee N, Anantharaja S, Oliver N. Switching from Flash Glucose Monitoring to Continuous Glucose Monitoring on Hypoglycemia in Adults with Type 1 Diabetes at High Hypoglycemia Risk: The Extension Phase of the I HART CGM Study. Diabetes Technol Ther. 2018 Nov;20(11):751-757. doi: 10.1089/dia.2018.0252. Epub 2018 Sep 28.

  PMID: 30265562 BACKGROUND

• Haskova A, Radovnicka L, Petruzelkova L, Parkin CG, Grunberger G, Horova E, Navratilova V, Kade O, Matoulek M, Prazny M, Soupal J. Real-time CGM Is Superior to Flash Glucose Monitoring for Glucose Control in Type 1 Diabetes: The CORRIDA Randomized Controlled Trial. Diabetes Care. 2020 Nov;43(11):2744-2750. doi: 10.2337/dc20-0112. Epub 2020 Aug 28.

  PMID: 32859607 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Hypoglycemia; Motor Activity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Behavior

Study Officials

• Jan Soupal

  Charles University, Prague

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 15, 2020
• First Posted: April 24, 2020
• Study Start: September 1, 2018
• Primary Completion: April 30, 2019
• Study Completion: November 30, 2020
• Last Updated: April 28, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)