Diabetes Mellitus, Type 1
Conditions
Keywords
Continuous Glucose Monitoring, Flash Glucose Monitoring, Hypoglycemia, Time in Range, Physical Activity
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.
Interventions
DEVICEContinuous Glucose Monitoring Guardian Connect Mobile system (real-time continuous glucose monitoring)
rtCGM and isCGM are used in Type 1 diabetic patients to improve glucose control and to minimize or avoid severe hypoglycaemia.
DEVICEContinuous Glucose Monitoring FreeStyle Libre Flash system (intermittently-scanned continuous glucose monitoring)
rtCGM and isCGM are 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
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| Changes in glycemic variability | Up to 2 months | Expressed as the coefficient of variation |
| Mean sensor glucose concentration | Up to 2 months | Measured by rtCGM or isCGM |
| Percentage of time in target ranges | Up to 2 months | 3,9-10,0 mmol/L (70-180 mg/dl) |
| Incidence of severe hypoglycaemia | Up to 2 months | Requiring third-party assistance to treat |
| 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. |
| 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. |
Countries
Czechia
Outcome results
None listed