Is Real-time CGM Superior to Flash Glucose Monitoring

Charles University, Czech Republic60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Diabetes Mellitus, Type 1

Interventions

Continuous Glucose Monitoring Guardian Connect Mobile system (real-time continuous glucose monitoring)DEVICE

rtCGM and isCGM are used in Type 1 diabetic patients to improve glucose control and to minimize or avoid severe hypoglycaemia.

Continuous Glucose Monitoring FreeStyle Libre Flash system (intermittently-scanned continuous glucose monitoring)DEVICE

rtCGM and isCGM are used in Type 1 diabetic patients to improve glucose control and to minimize or avoid severe hypoglycaemia.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

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

Prague, Czech Republic, Czechia

Outcomes

Primary Outcomes

Percentage of time in hypoglycemic ranges

\<3,9 mmol/L (70 mg/dl) and \<3,0 mmol/L (54 mg/dl)

Time frame: Up to 2 months

Secondary Outcomes

Percentage of time in target ranges

3,9-10,0 mmol/L (70-180 mg/dl)

Time frame: 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)

Time frame: Up to 2 months

Changes in glycemic variability

Expressed as the coefficient of variation

Time frame: Up to 2 months

Mean sensor glucose concentration

Measured by rtCGM or isCGM

Time frame: 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.

Time frame: Up to 2 months

Incidence of severe hypoglycaemia

Requiring third-party assistance to treat

Time frame: 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.

Data from ClinicalTrials.gov

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