Diabetes Mellitus, Type 1
Conditions
Keywords
ambulatory glucose profile, time in range, fear of hypoglycemia, continuous glucose monitoring
Brief summary
The aim of this trial is to investigate the impact of FreeStyle Libre use compared to SMBG on hypoglycemia episodes and fear of hypoglycemia in adults aged 18-35 with newly diagnosed type 1 diabetes. This trial is conducted in university centers in Poland (Bialystok, Krakow, Poznan, Zabrze).
Interventions
FreeStyle Libre, 4 weeks
Standard blood glucose monitoring with glucose meters
Sponsors
Diabetes Poland
Jagiellonian University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
* Newly diagnosed type 1 diabetes (diagnosed based on the WHO criteria) no later than 6 months after the diagnosis. * Insulin therapy: multiple daily injections, * In the investigator's opinion, the participant must be technically capable of using the FreeStyle Libre system
Exclusion criteria
* Current or past use of any continuous glucose monitoring system. * Pump therapy. * Known allergy to medical adhesives. * Oral steroid therapy. * Pregnancy or planning pregnancy within the study duration. * Breast feeding. * Dialysis treatment. * Having a pacemaker. * Unstable coronary heart disease. * Cystic fibrosis. * Cancer. * Psychiatric disorders. * Severe end-organ damage (kidney, liver, etc) or any uncontrolled disorder. * Hospitalization for any reason other than the newly diagnosed type 1 diabetes 6 months prior to inclusion. * Participating in another clinical trial that could affect glucose measurements or glucose management. * In the investigator's opinion, if the participant is considered unsuitable for inclusion in the study for any other reason.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hypoglycemia Fear Survey II | Baseline and day 28 | Change in HFS II score from baseline to day 28 |
| TBR <70 mg/dL | Baseline and days 14 to 28 | Difference in time \<70 mg/dL between intervention and control group assessed in days 14 to 28 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| TAR >180 mg/dl | Baseline and days 14 to 28 | Difference in TAR \>180 mg/dL between intervention and control group assessed in days 14 to 28 |
| TAR >250 mg/dl | Baseline and days 14 to 28 | Difference in TAR \>250 mg/dL between intervention and control group assessed in days 14 to 28 |
| DKA | Baseline to day 28 | Difference in number of hospitalizations for diabetic ketoacidosis between intervention and control group |
| Severe hypoglycemia | Baseline to day 28 | Difference in number of severe hypoglycemia episodes between intervention and control group |
| TIR | Baseline and days 14 to 28 | Difference in TIR 70-180 mg/dL between intervention and control group assessed in days 14 to 28 |
| DTSQ | Baseline and day 28 | Change in DTSQ score from baseline to day 28 |
| HFS II - Worry subscale | Baseline and day 28 | Change in HFS II - worry subscale from baseline to day 28 |
| HFS II - Behaviour subscale | Baseline and day 28 | Change in HFS II - behaviour subscale from baseline to day 28 |
| DDS | Baseline and day 28 | Change in DDS score from baseline to day 28 |
| TBR <54 mg/dL | Baseline and days 14 to 28 | Difference in TBR \<54 mg/dL between intervention and control group assessed in days 14 to 28 |
Countries
Poland
Outcome results
None listed