Is Real-time CGM Superior to Flash Glucose Monitoring (CORRIDA)
Primary Purpose
Diabetes Mellitus, Type 1
Status
Unknown status
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Continuous Glucose Monitoring Guardian Connect Mobile system (real-time continuous glucose monitoring)
Continuous Glucose Monitoring FreeStyle Libre Flash system (intermittently-scanned continuous glucose monitoring)
Sponsored by
About this trial
This is an interventional supportive care trial for Diabetes Mellitus, Type 1 focused on measuring Continuous Glucose Monitoring, Flash Glucose Monitoring, Hypoglycemia, Time in Range, Physical Activity
Eligibility Criteria
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
Sites / Locations
- 3rd Department of Internal Medicine, 1st Faculty of Medicine Charles University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
rtCGM
isCGM
Arm Description
Patients with use of the Guardian Connect Mobile system (real-time continuous glucose monitoring).
Patients with use of the FreeStyle Libre Flash system (intermittently-scanned continuous glucose monitoring).
Outcomes
Primary Outcome Measures
Percentage of time in hypoglycemic ranges
<3,9 mmol/L (70 mg/dl) and <3,0 mmol/L (54 mg/dl)
Secondary Outcome Measures
Percentage of time in target ranges
3,9-10,0 mmol/L (70-180 mg/dl)
Percentage of time in hyperglycemic ranges
(>10,0 mmol/L (180 mg/dl) and >13,9 mmol/L (250 mg/dl)
Changes in glycemic variability
Expressed as the coefficient of variation
Mean sensor glucose concentration
Measured by rtCGM or isCGM
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.
Incidence of severe hypoglycaemia
Requiring third-party assistance to treat
Changes in glycated haemoglobin (HbA1c)
Differences between HbA1c values in the initial period and after follow-up and differences of HbA1c between groups.
Full Information
NCT ID
NCT04358263
First Posted
April 15, 2020
Last Updated
April 24, 2020
Sponsor
Charles University, Czech Republic
1. Study Identification
Unique Protocol Identification Number
NCT04358263
Brief Title
Is Real-time CGM Superior to Flash Glucose Monitoring
Acronym
CORRIDA
Official Title
Comparison of CGM in Randomised Study of Real-time and Intermittently-scanned Systems in T1D With Normal Awareness of Hypoglycemia (CORRIDA)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
April 30, 2019 (Actual)
Study Completion Date
November 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charles University, Czech Republic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1
Keywords
Continuous Glucose Monitoring, Flash Glucose Monitoring, Hypoglycemia, Time in Range, Physical Activity
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
rtCGM
Arm Type
Experimental
Arm Description
Patients with use of the Guardian Connect Mobile system (real-time continuous glucose monitoring).
Arm Title
isCGM
Arm Type
Experimental
Arm Description
Patients with use of the FreeStyle Libre Flash system (intermittently-scanned continuous glucose monitoring).
Intervention Type
Device
Intervention Name(s)
Continuous Glucose Monitoring Guardian Connect Mobile system (real-time continuous glucose monitoring)
Intervention Description
rtCGM and isCGM are used in Type 1 diabetic patients to improve glucose control and to minimize or avoid severe hypoglycaemia.
Intervention Type
Device
Intervention Name(s)
Continuous Glucose Monitoring FreeStyle Libre Flash system (intermittently-scanned continuous glucose monitoring)
Intervention Description
rtCGM and isCGM are used in Type 1 diabetic patients to improve glucose control and to minimize or avoid severe hypoglycaemia.
Primary Outcome Measure Information:
Title
Percentage of time in hypoglycemic ranges
Description
<3,9 mmol/L (70 mg/dl) and <3,0 mmol/L (54 mg/dl)
Time Frame
Up to 2 months
Secondary Outcome Measure Information:
Title
Percentage of time in target ranges
Description
3,9-10,0 mmol/L (70-180 mg/dl)
Time Frame
Up to 2 months
Title
Percentage of time in hyperglycemic ranges
Description
(>10,0 mmol/L (180 mg/dl) and >13,9 mmol/L (250 mg/dl)
Time Frame
Up to 2 months
Title
Changes in glycemic variability
Description
Expressed as the coefficient of variation
Time Frame
Up to 2 months
Title
Mean sensor glucose concentration
Description
Measured by rtCGM or isCGM
Time Frame
Up to 2 months
Title
Changes in quality of life as assessed by validated questionnaire
Description
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.
Time Frame
Up to 2 months
Title
Incidence of severe hypoglycaemia
Description
Requiring third-party assistance to treat
Time Frame
Up to 2 months
Title
Changes in glycated haemoglobin (HbA1c)
Description
Differences between HbA1c values in the initial period and after follow-up and differences of HbA1c between groups.
Time Frame
Up to 2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Soupal
Organizational Affiliation
Charles University, Prague
Official's Role
Principal Investigator
Facility Information:
Facility Name
3rd Department of Internal Medicine, 1st Faculty of Medicine Charles University
City
Prague
State/Province
Czech Republic
Country
Czechia
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
18996798
Citation
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.
Results Reference
background
PubMed Identifier
26317981
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.
Results Reference
background
PubMed Identifier
20723825
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.
Results Reference
background
PubMed Identifier
30348844
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.
Results Reference
background
PubMed Identifier
28118453
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.
Results Reference
background
PubMed Identifier
27482825
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.
Results Reference
background
PubMed Identifier
31530663
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.
Results Reference
background
PubMed Identifier
29273897
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.
Results Reference
background
PubMed Identifier
30265562
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.
Results Reference
background
PubMed Identifier
32859607
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.
Results Reference
derived
Learn more about this trial
Is Real-time CGM Superior to Flash Glucose Monitoring
We'll reach out to this number within 24 hrs