Is Real-time CGM Superior to Flash Glucose Monitoring

Not Applicable

• Conditions: Diabetes Mellitus, Type 1
• Interventions: 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)

• Registration Number: NCT04358263
• Lead Sponsor: Charles University, Czech Republic

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-01
• Primary Completion: 2019-04-30
• Status Verified: 2020-04
• Study First Submitted: 2020-04-15
• Study First Submitted QC: 2020-04-22
• Study First Posted: 2020-04-24
• Last Update Submitted: 2020-04-24
• Last Update Posted: 2020-04-28
• Study Completion: 2020-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
rtCGM	Continuous Glucose Monitoring Guardian Connect Mobile system (real-time continuous glucose monitoring)	Patients with use of the Guardian Connect Mobile system (real-time continuous glucose monitoring).
isCGM	Continuous Glucose Monitoring FreeStyle Libre Flash system (intermittently-scanned continuous glucose monitoring)	Patients with use of the FreeStyle Libre Flash system (intermittently-scanned continuous glucose monitoring).

Primary Outcome Measures

Name	Time	Method
Percentage of time in hypoglycemic ranges	Up to 2 months	\<3,9 mmol/L (70 mg/dl) and \<3,0 mmol/L (54 mg/dl)

Secondary Outcome Measures

Name	Time	Method
Changes in glycemic variability	Up to 2 months	Expressed as the coefficient of variation
Percentage of time in hyperglycemic ranges	Up to 2 months	(\>10,0 mmol/L (180 mg/dl) and \>13,9 mmol/L (250 mg/dl)
Mean sensor glucose concentration	Up to 2 months	Measured by rtCGM or isCGM
Changes in glycated haemoglobin (HbA1c)	Up to 2 months	Differences between HbA1c values in the initial period and after follow-up and differences of HbA1c between groups.
Percentage of time in target ranges	Up to 2 months	3,9-10,0 mmol/L (70-180 mg/dl)
Changes in quality of life as assessed by validated questionnaire	Up to 2 months	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	Up to 2 months	Requiring third-party assistance to treat

Trial Locations

Locations (1)

3rd Department of Internal Medicine, 1st Faculty of Medicine Charles University; 🇨🇿 Prague, Czech Republic, Czechia