Is Real-time CGM Superior to Flash Glucose Monitoring

Diabetes Mellitus, Type 1 Clinical Trial

— CORRIDA  

Official title:

Comparison of CGM in Randomised Study of Real-time and Intermittently-scanned Systems in T1D With Normal Awareness of Hypoglycemia (CORRIDA)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04358263
• Other study ID #: CORRIDA
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: November 30, 2020

Study information

• Verified date: April 2020
• 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 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: November 30, 2020
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1

Intervention

Device:
• Continuous Glucose Monitoring Guardian Connect Mobile system (real-time continuous glucose monitoring)
rtCGM and isCGM are used in Type 1 diabetic patients to improve glucose control and to minimize or avoid severe hypoglycaemia.
• Continuous Glucose Monitoring FreeStyle Libre Flash system (intermittently-scanned continuous glucose monitoring)
rtCGM and isCGM are 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	Czech Republic

Sponsors (1)

Lead Sponsor	Collaborator
Charles University, Czech Republic

Country where clinical trial is conducted

Czechia, 

References & Publications (9)

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

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. Review. — View Citation

Cryer PE. Hypoglycemia: still the limiting factor in the glycemic management of diabetes. Endocr Pract. 2008 Sep;14(6):750-6. Review. — View Citation

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. Review. — View Citation

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. — 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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of time in target ranges	3,9-10,0 mmol/L (70-180 mg/dl)	Up to 2 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 2 months
Secondary	Changes in glycemic variability	Expressed as the coefficient of variation	Up to 2 months
Secondary	Mean sensor glucose concentration	Measured by rtCGM or isCGM	Up to 2 months
Secondary	Changes in quality of life as assessed by validated questionnaire	Assessed by The World Health Organization Quality of Life (WHOQOL)-BREF (Field Trial Version).; This questionnaire contains in total 26 questions in four Domains (Physical health, Psychological health, Social relationships, Environment). Scores in total range between 4-20 (each Domain 0-5), higher scores denote higher quality of life.	Up to 2 months
Secondary	Incidence of severe hypoglycaemia	Requiring third-party assistance to treat	Up to 2 months
Secondary	Changes in glycated haemoglobin (HbA1c)	Differences between HbA1c values in the initial period and after follow-up and differences of HbA1c between groups.	Up to 2 months