Diabetes Mellitus, Type 1
Conditions
Keywords
Continuous Glucose Monitoring, Flash Glucose Monitoring, Hypoglycaemia, Time in Range
Brief 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.
Interventions
DEVICEContinuous Glucose Monitoring Dexcom G5 and G6 system (real-time continuous glucose monitoring)
rtCGM is used in Type 1 diabetic patients to improve glucose control and to minimize or avoid severe hypoglycaemia.
DEVICEContinuous Glucose Monitoring FreeStyle Libre Flash system (flash glucose monitoring)
FGM is used in Type 1 diabetic patients to improve glucose control and to minimize or avoid severe hypoglycaemia.
Sponsors
Charles University, Czech Republic
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in glycated haemoglobin (HbA1c) | Up to 13 months | Differences between HbA1c values in the Run in period and after 12 month of follow-up and differences of HbA1c between groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of time in hypoglycemic ranges | Up to 13 months | \<3.9 mmol/L \[70 mg/dl\] and \<3.0 mmol/L \[54 mg/dl\] |
| Percentage of time in target ranges | Up to 13 months | 3.9-10.0 mmol/L \[70-180 mg/dl\] |
| Percentage of time in hyperglycemic ranges | Up to 13 months | \>10.0 mmol/L \[180 mg/dl\] and \>13.9 mmol/L \[250 mg/dl\] |
| Incidence of skin reaction, infection or hematoma at the site of insertion of the sensor | Up to 13 months | Skin reaction, infection or hematoma reported by patients |
| Mean sensor glucose concentration | Up to 13 months | Measured by rtCGM or FGM |
| Incidence of severe hypoglycaemia | Up to 13 months | Requiring third-party assistance to treat |
| Incidence of severe ketoacidosis | Up to 13 months | Requiring hospitalization |
| Changes in glycemic variability | Up to 13 months | Expressed as the standard deviation |
Countries
Czechia
Outcome results
None listed