Assessment of safety and glycaemia during application of the hybrid closed-loop system on the basis of the AndroidAPS application.

• Conditions: E10; Type 1 diabetes mellitus

• Registration Number: DRKS00015439
• Lead Sponsor: Diabetes Poland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-04
• Study Completion: 2019-12-19
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 12

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

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

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Demonstration of the safety of the hybrid closed-loop system in adults with type 1 diabetes.<br>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: <br>• number of hypoglycemic episodes <3.0mmol/l, <br>• time spent in hypoglycemia <3.0mmol/l; <br>• severe hypoglycemia, <br>• diabetic ketoacidosis <br>All the data from this period will determine the primary outcome.

Secondary Outcome Measures

Name	Time	Method
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).<br>3. Demonstration of the effectiveness of the basal infusion modulation in the hyperglycemia correction by the AndroidAPS system.<br>4. Demonstration of the improvement in patients' satisfaction with HCL system based on the AndroidAPS application.<br>The secondary endpoints will be examined during all 90 days of observation time and at the and of the study (metabolic control improvement).<br>