Clinical trial NCT06709729: Switch of AndroidAPS to Commercially Available AID Systems
Official title: Switch of Open-source Automated Insulin Delivery System - AndroidAPS to Commercially Available AID Systems in Type 1 Diabetes: the Extension of the CODIAC Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Keywords: Insulin Pump
Closed-loop hybrid system
Continuous Glucose Monitoring
Automated Insulin Delivery
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
Collaborators: name: General University Hospital, Prague
First posted: 2024-11-29
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The aim of the study was to investigate the switch between open-source automated insulin delivery system (OS-AID) - AndroidAPS (AAPS) and commercially available AID systems - Control-IQ (CIQ) and MiniMed 780G (780G) in extended follow-up study.


Eligibility criteria: Inclusion Criteria:

* type 1 diabetes diagnosed \>2 years
* ≥ 18 years old
* written informed consent prior to starting study related activity
* previous user of AndroidAPS at least for 3 months

Exclusion Criteria:

* nonadherence to the current treatment regimen
* lactation
* pregnancy
* intending to become pregnant during study
* concomitant therapy influencing glucose metabolism

Primary outcomes:
measure: Percentage of time in target ranges
timeFrame: 14 weeks
Secondary outcomes:
measure: Percentage of time in hypoglycemic range
timeFrame: 14 weeks
measure: Percentage of time in hyperglycemic range
timeFrame: 14 weeks
measure: Percentage of time in tight range
timeFrame: 14 weeks
measure: Changes in glycemic variability
timeFrame: 14 weeks
measure: Icidence of severe hypoglycaemia
timeFrame: 14 weeks
measure: Changes in glycated haemoglobin (HbA1c)
timeFrame: 14 weeks
measure: Hypoglycemia Attitudes and Behavior Scale (HABS)
timeFrame: 14 weeks
measure: Diabetec distress as assessed by validated questionnaire
timeFrame: 14 weeks
measure: The 5-item World Health Organization well-being index as assessed by validated questionnaire
timeFrame: 14 weeks
Other outcomes:
Locations:
city: Prague 2
country: Czech Republic
facility: 3rd Department of Internal Medicine, 1st Faculty of Medicine, Charles University
Study officials:
affiliation: 3rd Department of Internal Medicine, 1st Faculty of Medicine, Charles University
name: Jan Soupal
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hajos TR, Pouwer F, Skovlund SE, Den Oudsten BL, Geelhoed-Duijvestijn PH, Tack CJ, Snoek FJ. Psychometric and screening properties of the WHO-5 well-being index in adult outpatients with Type 1 or Type 2 diabetes mellitus. Diabet Med. 2013 Feb;30(2):e63-9. doi: 10.1111/dme.12040.
citation: Do QD, Haskova A, Radovnicka L, Konecna J, Horova E, Parkin CG, Grunberger G, Prazny M, Soupal J. Comparison of Control-IQ and open-source AndroidAPS automated insulin delivery systems in adults with type 1 diabetes: The CODIAC study. Diabetes Obes Metab. 2024 Jan;26(1):78-84. doi: 10.1111/dom.15289. Epub 2023 Sep 25.
citation: Haskova A, Radovnicka L, Petruzelkova L, Parkin CG, Grunberger G, Horova E, Navratilova V, Kade O, Matoulek M, Prazny M, Soupal J. Real-time CGM Is Superior to Flash Glucose Monitoring for Glucose Control in Type 1 Diabetes: The CORRIDA Randomized Controlled Trial. Diabetes Care. 2020 Nov;43(11):2744-2750. doi: 10.2337/dc20-0112. Epub 2020 Aug 28.
citation: Soupal J, Petruzelkova L, Flekac M, Pelcl T, Matoulek M, Dankova M, Skrha J, Svacina S, Prazny M. Comparison of Different Treatment Modalities for Type 1 Diabetes, Including Sensor-Augmented Insulin Regimens, in 52 Weeks of Follow-Up: A COMISAIR Study. Diabetes Technol Ther. 2016 Sep;18(9):532-8. doi: 10.1089/dia.2016.0171. Epub 2016 Aug 2.
citation: Soupal J, Petruzelkova L, Grunberger G, Haskova A, Flekac M, Matoulek M, Mikes O, Pelcl T, Skrha J Jr, Horova E, Skrha J, Parkin CG, Svacina S, Prazny M. Glycemic Outcomes in Adults With T1D Are Impacted More by Continuous Glucose Monitoring Than by Insulin Delivery Method: 3 Years of Follow-Up From the COMISAIR Study. Diabetes Care. 2020 Jan;43(1):37-43. doi: 10.2337/dc19-0888. Epub 2019 Sep 17.