Clinical trial NCT04759495: Is Real-time CGM Superior to Flash Glucose Monitoring in Real Life Study (CORRIDA LIFE)
Official title: Comparison of CGM in Non-randomised Real Life Study of Real-time and Intermittently Scanned Systems in Patients With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Keywords: Continuous Glucose Monitoring
Flash Glucose Monitoring
Hypoglycaemia
Time in Range
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
First posted: 2021-02-18
Enrollment: 187
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Changes in glycated haemoglobin (HbA1c)
timeFrame: Up to 13 months
Secondary outcomes:
measure: Percentage of time in hypoglycemic ranges
timeFrame: Up to 13 months
measure: Percentage of time in target ranges
timeFrame: Up to 13 months
measure: Percentage of time in hyperglycemic ranges
timeFrame: Up to 13 months
measure: Changes in glycemic variability
timeFrame: Up to 13 months
measure: Mean sensor glucose concentration
timeFrame: Up to 13 months
measure: Incidence of severe hypoglycaemia
timeFrame: Up to 13 months
measure: Incidence of severe ketoacidosis
timeFrame: Up to 13 months
measure: Incidence of skin reaction, infection or hematoma at the site of insertion of the sensor
timeFrame: Up to 13 months
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: 3rd Department of Internal Medicine, 1st Faculty of Medicine, Charles University
Study officials:
affiliation: Charles University, Prague
name: Jan Soupal
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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;2014(2):CD009122. doi: 10.1002/14651858.CD009122.pub2.
citation: 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.
citation: 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.
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.
citation: 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.
citation: Bolinder J, Antuna R, Geelhoed-Duijvestijn P, Kroger 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.
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.
citation: Radovnicka L, Haskova A, Do QD, Horova E, Navratilova V, Mikes O, Cihlar D, Parkin CG, Grunberger G, Prazny M, Soupal J. Lower Glycated Hemoglobin with Real-Time Continuous Glucose Monitoring Than with Intermittently Scanned Continuous Glucose Monitoring After 1 Year: The CORRIDA LIFE Study. Diabetes Technol Ther. 2022 Dec;24(12):859-867. doi: 10.1089/dia.2022.0152. Epub 2022 Sep 22.