Is Real-time CGM Superior to Flash Glucose Monitoring in Real Life Study (CORRIDA LIFE)

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

Comparison of CGM in Non-randomised Real Life Study of Real-time and Intermittently Scanned Systems in Patients With Type 1 Diabetes

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04759495
• Other study ID #: CORRIDA LIFE
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 1, 2019
• Est. completion date: September 30, 2021

Study information

• Verified date: February 2021
• Source: Charles University, Czech Republic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the investigator's study is to compare real-time continuous glucose monitoring (rt-CGM) and flash glucose monitoring (FGM) in adult patients with Type 1 Diabetes (T1D) in real life practice during 24 weeks of follow-up.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 187
• Est. completion date: September 30, 2021
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients with T1D naive to rt-CGM and FGM

• Type 1 diabetes for > 1 year

• = 18 years old

• CSII without automatic functions or MDI

Exclusion Criteria:

• previous rtCGM or FGM use

• treatment with insulin pump with automatic functions

• severe noncompliance

• known severe diabetic retinopathy and/or macular edema

• lactation, pregnancy, or intending to become pregnant during the study

• a condition likely to require MRI

• use of acetaminophen-containing medication

• unwillingness to use the study device for >70% of time

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1

Intervention

Device:
• Continuous Glucose Monitoring Dexcom G5 and G6 system (real-time continuous glucose monitoring)
rtCGM is used in Type 1 diabetic patients to improve glucose control and to minimize or avoid severe hypoglycaemia.
• Continuous Glucose Monitoring FreeStyle Libre Flash system (flash glucose monitoring)
FGM is used in Type 1 diabetic patients to improve glucose control and to minimize or avoid severe hypoglycaemia.

Locations

Country	Name	City	State
Czechia	3rd Department of Internal Medicine, 1st Faculty of Medicine, Charles University	Prague

Sponsors (1)

Lead Sponsor	Collaborator
Charles University, Czech Republic

Country where clinical trial is conducted

Czechia, 

References & Publications (8)

Šoupal J, Petruželková L, Flekac M, Pelcl T, Matoulek M, Danková M, Škrha J, Svacina Š, Prázný 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. — View Citation

Šoupal J, Petruželková L, Grunberger G, Hásková A, Flekac M, Matoulek M, Mikeš O, Pelcl T, Škrha J Jr, Horová E, Škrha J, Parkin CG, Svacina Š, Prázný 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. — View Citation

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. — View Citation

Bolinder J, Antuna R, Geelhoed-Duijvestijn P, Kröger J, Weitgasser R. Novel glucose-sensing technology and hypoglycaemia in type 1 diabetes: a multicentre, non-masked, randomised controlled trial. Lancet. 2016 Nov 5;388(10057):2254-2263. doi: 10.1016/S0140-6736(16)31535-5. Epub 2016 Sep 12. — View Citation

Fullerton B, Jeitler K, Seitz M, Horvath K, Berghold A, Siebenhofer A. Intensive glucose control versus conventional glucose control for type 1 diabetes mellitus. Cochrane Database Syst Rev. 2014 Feb 14;(2):CD009122. doi: 10.1002/14651858.CD009122.pub2. Review. — View Citation

Hásková A, Radovnická L, Petruželková L, Parkin CG, Grunberger G, Horová E, Navrátilová V, Káde O, Matoulek M, Prázný M, Šoupal 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. — View Citation

Heinemann L, Freckmann G, Ehrmann D, Faber-Heinemann G, Guerra S, Waldenmaier D, Hermanns N. Real-time continuous glucose monitoring in adults with type 1 diabetes and impaired hypoglycaemia awareness or severe hypoglycaemia treated with multiple daily insulin injections (HypoDE): a multicentre, randomised controlled trial. Lancet. 2018 Apr 7;391(10128):1367-1377. doi: 10.1016/S0140-6736(18)30297-6. Epub 2018 Feb 16. — View Citation

Oskarsson P, Antuna R, Geelhoed-Duijvestijn P, Kr?ger 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in glycated haemoglobin (HbA1c)	Differences between HbA1c values in the Run in period and after 12 month of follow-up and differences of HbA1c between groups.	Up to 13 months
Secondary	Percentage of time in hypoglycemic ranges	<3.9 mmol/L [70 mg/dl] and <3.0 mmol/L [54 mg/dl]	Up to 13 months
Secondary	Percentage of time in target ranges	3.9-10.0 mmol/L [70-180 mg/dl]	Up to 13 months
Secondary	Percentage of time in hyperglycemic ranges	>10.0 mmol/L [180 mg/dl] and >13.9 mmol/L [250 mg/dl]	Up to 13 months
Secondary	Changes in glycemic variability	Expressed as the standard deviation	Up to 13 months
Secondary	Mean sensor glucose concentration	Measured by rtCGM or FGM	Up to 13 months
Secondary	Incidence of severe hypoglycaemia	Requiring third-party assistance to treat	Up to 13 months
Secondary	Incidence of severe ketoacidosis	Requiring hospitalization	Up to 13 months
Secondary	Incidence of skin reaction, infection or hematoma at the site of insertion of the sensor	Skin reaction, infection or hematoma reported by patients	Up to 13 months