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Diabetes Mellitus, Type 1NCT04759495

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

A study testing Continuous Glucose Monitoring Dexcom G5 and G6 system (real-time continuous glucose monitoring) and Continuous Glucose Monitoring FreeStyle Libre Flash system (flash glucose monitoring) in people with Diabetes Mellitus, Type 1, run by Charles University, Czech Republic at 1 site in Czechia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus, Type 1
What is being tested?
Continuous Glucose Monitoring Dexcom G5 and G6 system (real-time continuous glucose monitoring) and Continuous Glucose Monitoring FreeStyle Libre Flash system (flash glucose monitoring)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
187 participants
Where
1 siteCzechia
Study dates
1 Jun 2019to 30 Sep 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • patients with T1D naive to rt-CGM and FGM
  • Type 1 diabetes for > 1 year
  • ≥ 18 years old
  • CSII without automatic functions or MDI

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Czechia1 site

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

    Prague

Other trials in Czechia

About this study

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

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.

Being tested
Continuous Glucose Monitoring Dexcom G5 and G6 system (real-time continuous glucose monitoring), Continuous Glucose Monitoring FreeStyle Libre Flash system (flash glucose monitoring)
Keywords
Continuous Glucose Monitoring, Flash Glucose Monitoring, Hypoglycaemia, Time in Range
Medical subject headings
Diabetes Mellitus, Type 1, Hypoglycemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Continuous Glucose Monitoring Dexcom G5 and G6 system (real-time continuous glucose monitoring)Device

    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)Device

    FGM is used in Type 1 diabetic patients to improve glucose control and to minimize or avoid severe hypoglycaemia.

Study groups in NCT04759495
Study groupRoleWhat they receive
rtCGMExperimentalPatients with use of the DEXCOM G5 or G6 system (real time continuous glucose monitoring).
Receives: Device: Continuous Glucose Monitoring Dexcom G5 and G6 system (real-time continuous glucose monitoring)
FGMExperimentalPatients with use of the FreeStyle Libre Flash system (flash glucose monitoring).
Receives: Device: Continuous Glucose Monitoring FreeStyle Libre Flash system (flash glucose monitoring)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 13 months

Secondary outcomes (8)

  1. Percentage of time in hypoglycemic ranges

    <3.9 mmol/L [70 mg/dl] and <3.0 mmol/L [54 mg/dl]

    Measured: Up to 13 months

  2. Percentage of time in target ranges

    3.9-10.0 mmol/L [70-180 mg/dl]

    Measured: Up to 13 months

  3. Percentage of time in hyperglycemic ranges

    >10.0 mmol/L [180 mg/dl] and >13.9 mmol/L [250 mg/dl]

    Measured: Up to 13 months

  4. Changes in glycemic variability

    Expressed as the standard deviation

    Measured: Up to 13 months

  5. Mean sensor glucose concentration

    Measured by rtCGM or FGM

    Measured: Up to 13 months

  6. Incidence of severe hypoglycaemia

    Requiring third-party assistance to treat

    Measured: Up to 13 months

  7. Incidence of severe ketoacidosis

    Requiring hospitalization

    Measured: Up to 13 months

  8. Incidence of skin reaction, infection or hematoma at the site of insertion of the sensor

    Skin reaction, infection or hematoma reported by patients

    Measured: Up to 13 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Feb 2021
  2. Study start1 Jun 2019
  3. Primary completion30 Nov 2020
  4. Study completion30 Sep 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
187 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04759495
Sponsor's protocol ID
CORRIDA LIFE
Status last verified
Feb 2021
First submitted
15 Feb 2021
Last updated
18 Feb 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 32859607

  • 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.

    PubMed 24526393

  • 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.

    PubMed 27482825

  • 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.

    PubMed 31530663

  • 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.

    PubMed 28118453

  • 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.

    PubMed 29273897

  • 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.

    PubMed 27634581

  • 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.

    PubMed 29459019

  • 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.

    PubMed 36037056

Questions about this trial

What is this clinical trial studying?

A study testing Continuous Glucose Monitoring Dexcom G5 and G6 system (real-time continuous glucose monitoring) and Continuous Glucose Monitoring FreeStyle Libre Flash system (flash glucose monitoring) in people with Diabetes Mellitus, Type 1, run by Charles University, Czech Republic at 1 site in Czechia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in glycated haemoglobin (HbA1c) (time frame: Up to 13 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04759495, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2021.

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