E10
Conditions
Interventions
Group 1: We plan to observe 10 patients with T1D for 120 days each. The study will be carried out sequentially in two groups of 5 people. The participants will be patients with T1D who are under the
Sponsors
Diabetes Poland
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1. age 18-40 2. type 1 diabetes 3. duration of diabetes > 5 years 4. treatment with a personal insulin pump from > 1 year 5. using the bolus calculator 6. experience in CGM system: using o f= 70% of the time in the last 3 months 7. HbA1c <9% 8. BMI 18-30 kg / m2 9. consent to participate in the study
Exclusion criteria
Exclusion criteria: Exclusion criteria: 1. persistence of partial remission of type 1 diabetes 2. identified advanced chronic micro- and macroangiopathic complications of diabetes (proliferative retinopathy, diabetic kidney disease with eGFR <60 mL/min/1.73 m2, cardiac autonomic neuropathy, coronary heart disease, stroke) 3. severe hypoglycemia in the last year 4. hypoglycemia unawareness 5. ketoacidosis in the last 3 months 6. accompanying diseases except hypothyroidism in the state of euthyreosis 7. eating disorders, depression 8. smoking
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Demonstration of the safety of the hybrid closed-loop system in adults with type 1 diabetes. To determine the primary outcome the data on safety of the closed-loop system based on AndroidAPS application will be collected during 90 days observation time. These data consist of determining: • number of hypoglycemic episodes <3.0mmol/l, • time spent in hypoglycemia <3.0mmol/l; • severe hypoglycemia, • diabetic ketoacidosis All the data from this period will determine the primary outcome. | — |
Secondary
| Measure | Time frame |
|---|---|
| 2. Demonstration of the improvement in metabolic control of diabetes mellitus with HCL system based on the AndroidAPS application in type 1 diabetes (improvement in HbA1c, fructosamine concentrations, reduction of time in hypoglycemia, increase / prolongation of the time in range). 3. Demonstration of the effectiveness of the basal infusion modulation in the hyperglycemia correction by the AndroidAPS system. 4. Demonstration of the improvement in patients' satisfaction with HCL system based on the AndroidAPS application. The secondary endpoints will be examined during all 90 days of observation time and at the and of the study (metabolic control improvement). | — |
Countries
Poland
Contacts
Public ContactAndrzej Gawrecki
Poznan University of Medical Sciences, Department of Internal Medicine and Diabetology
Outcome results
None listed