Clinical trial NCT05165615: Android Artificial Pancreas System (Android APS) Versus Control-IQ
Official title: Comparison of the Two Different Closed-loop Hybrid Systems - AndroidAPS and Control-IQ in Patients With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Keywords: Continuous Glucose Monitoring
Insulin Pump
Closed-loop hybrid system
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
First posted: 2021-12-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of the investigator's study is to compare two different closed loop hybrid systems - certified Control-IQ and noncertified AndroidAPS in adult patients with Type 1 Diabetes (T1D), who had been using AndroidAPS previously from their own decision, during 12 weeks of follow-up.


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:

* severe noncompliance
* lactation, pregnancy, intending to become pregnant during study
* use of medication with effects on carbohydrate metabolism

Primary outcomes:
measure: Percentage of time in target ranges
timeFrame: Up to 28 weeks
Secondary outcomes:
measure: Percentage of time in hypoglycemic ranges
timeFrame: Up to 28 weeks
measure: Percentage of time in hyperglycemic ranges
timeFrame: Up to 28 weeks
measure: Changes in glycemic variability
timeFrame: Up to 28 weeks
measure: Incidence of severe hypoglycaemia
timeFrame: Up to 28 weeks
measure: Changes in glycated haemoglobin (HbA1c)
timeFrame: Up to 28 weeks
measure: Hypoglycemia Attitudes and Behavior Scale (HABS)
timeFrame: Up to 28 weeks
measure: Diabetes Distress Scale (DDS)
timeFrame: Up to 28 weeks
measure: The 5-item World Health Organization well-being index (WHO-5 index)
timeFrame: Up to 28 weeks
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: 3rd Department of Internal Medicine, 1st Faculty of Medicine, Charles University
Study officials:
affiliation: Charles University, Prague
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: Fisher L, Hessler DM, Polonsky WH, Mullan J. When is diabetes distress clinically meaningful?: establishing cut points for the Diabetes Distress Scale. Diabetes Care. 2012 Feb;35(2):259-64. doi: 10.2337/dc11-1572. Epub 2012 Jan 6.
citation: Polonsky WH, Fisher L, Hessler D, Liu J, Fan L, McAuliffe-Fogarty AH. Worries and concerns about hypoglycemia in adults with type 1 diabetes: An examination of the reliability and validity of the Hypoglycemic Attitudes and Behavior Scale (HABS). J Diabetes Complications. 2020 Jul;34(7):107606. doi: 10.1016/j.jdiacomp.2020.107606. Epub 2020 Apr 23.
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.
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: 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.