Switch of AndroidAPS to Commercially Available AID Systems

NCT ID: NCT06709729

Last Updated: 2024-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-01

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus, Type 1

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Insulin Pump Closed-loop hybrid system Continuous Glucose Monitoring Automated Insulin Delivery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control-IQ or Smartguard system

Patients with use of the Control-IQ system or Smartguard system (closed-loop hybrid system) and previous users of AndroidAPS (closed-loop hybrid system)

Group Type EXPERIMENTAL

Insulin pump with closed-loop system

Intervention Type DEVICE

Device: Usage of Insulin pump t:slim X2 with Control-IQ technology or MiniMed 780G with Smartguard technology in previous users of AndroidAPS

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Insulin pump with closed-loop system

Device: Usage of Insulin pump t:slim X2 with Control-IQ technology or MiniMed 780G with Smartguard technology in previous users of AndroidAPS

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Insulin pump t:slim X2 with Control-IQ technology Insulin pump MiniMed 780G with Smartguard technology in previous users of AndroidAPS

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

General University Hospital, Prague

OTHER

Sponsor Role collaborator

Charles University, Czech Republic

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jan Soupal

Role: PRINCIPAL_INVESTIGATOR

3rd Department of Internal Medicine, 1st Faculty of Medicine, Charles University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

3rd Department of Internal Medicine, 1st Faculty of Medicine, Charles University

Prague, Czech Republic, Czechia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Czechia

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 23072401 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37743832 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32859607 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27482825 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31530663 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CODIAC Extension

Identifier Type: -

Identifier Source: org_study_id