Is Real-time CGM Superior to Flash Glucose Monitoring

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 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.

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

Conditions
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Diabetes Mellitus, Type 1

Intervention / Treatment
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* Device: Continuous Glucose Monitoring Guardian Connect Mobile system (real-time continuous glucose monitoring)
* Device: Continuous Glucose Monitoring FreeStyle Libre Flash system (intermittently-scanned continuous glucose monitoring)


Participation Criteria
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Eligibility Criteria
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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

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: 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 Guardian Connect Mobile system (real-time continuous glucose monitoring). | Device: Continuous Glucose Monitoring Guardian Connect Mobile system (real-time continuous glucose monitoring)<br>* rtCGM and isCGM are used in Type 1 diabetic patients to improve glucose control and to minimize or avoid severe hypoglycaemia.<br>|
| Experimental: isCGM<br>Patients with use of the FreeStyle Libre Flash system (intermittently-scanned continuous glucose monitoring). | Device: Continuous Glucose Monitoring FreeStyle Libre Flash system (intermittently-scanned continuous glucose monitoring)<br>* rtCGM and isCGM are 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 |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of time in target ranges | 3,9-10,0 mmol/L (70-180 mg/dl) | Up to 2 months | 
| 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 | 
| Changes in glycemic variability | Expressed as the coefficient of variation | Up to 2 months | 
| Mean sensor glucose concentration | Measured by rtCGM or isCGM | Up to 2 months | 
| 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 | 
| Incidence of severe hypoglycaemia | Requiring third-party assistance to treat | Up to 2 months | 
| 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 | 

 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, Hypoglycemia, Time in Range, Physical Activity