Type1diabetes
Conditions
Brief summary
Cross-over study of 20 pediatric patients (age 7-19) randomized to the group receiving universal fixed meal boluses coefficients (300/TDD for breakfast and 400/TDD other meal) or to the group with individualized coefficients for the period of 14 days with consecutive analysis of the results from Carelink Raport.
Interventions
DEVICEUniversal meal coefficient utilization
Usage of universal fixed meal bolus coefficients for the control of postprandial hyperglycemia compared to individualized coefficients n the users of Medtronic Minimed 780G pumps
Sponsors
Estonia Research Council
Tartu University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
7 Years to 19 Years
Healthy volunteers
No
Inclusion criteria
* age 7-19 * type 1 diabetes diagnosed at least 1 year ago * insulin in the dose 0,5-1,0 units/day/kg * MiniMed 780G pump usage at least 1 month.
Exclusion criteria
* Active coeliac disease * Chronic disease possible to influence diabetes treatment * Acute disease at the moment of recruitment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time in range (TIR) | 4 weeks | Comparision of TIR between groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| TBR | 4 weeks | Comparision of TBR between groups |
| TAR | 4 weeks | Comparision of TAR between groups |
| auto-corrections % | 4 weeks | auto-corrections % between groups |
| coefficient of variability | 4 weeks | coefficient of variability between groups |
Countries
Estonia
Contacts
Primary ContactAleksandr Peet, MD, PhD
Backup ContactAleksandr Peet, MD, PhD
Outcome results
None listed