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

Study Overview
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Brief Summary
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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.

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

Conditions
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Diabetes Mellitus, Type 1

Intervention / Treatment
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* Device: Continuous Glucose Monitoring Dexcom G5 and G6 system (real-time continuous glucose monitoring)
* Device: Continuous Glucose Monitoring FreeStyle Libre Flash system (flash glucose monitoring)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: rtCGM<br>Patients with use of the DEXCOM G5 or G6 system (real time continuous glucose monitoring). | Device: Continuous Glucose Monitoring Dexcom G5 and G6 system (real-time continuous glucose monitoring)<br>* rtCGM is used in Type 1 diabetic patients to improve glucose control and to minimize or avoid severe hypoglycaemia.<br>|
| Experimental: FGM<br>Patients with use of the FreeStyle Libre Flash system (flash glucose monitoring). | Device: Continuous Glucose Monitoring FreeStyle Libre Flash system (flash glucose monitoring)<br>* FGM is used in Type 1 diabetic patients to improve glucose control and to minimize or avoid severe hypoglycaemia.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Percentage of time in target ranges | 3.9-10.0 mmol/L [70-180 mg/dl] | Up to 13 months | 
| 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 | 
| Changes in glycemic variability | Expressed as the standard deviation | Up to 13 months | 
| Mean sensor glucose concentration | Measured by rtCGM or FGM | Up to 13 months | 
| Incidence of severe hypoglycaemia | Requiring third-party assistance to treat | Up to 13 months | 
| Incidence of severe ketoacidosis | Requiring hospitalization | Up to 13 months | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Continuous Glucose Monitoring, Flash Glucose Monitoring, Hypoglycaemia, Time in Range