Switch of AndroidAPS to Commercially Available AID Systems

NCT06709729 | Active Not Recruiting FDA Device

• 1 other identifier: CODIAC Extension
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 1

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Percentage of time in target ranges

  3.9-10.0 mmol/L \[70-180 mg/dL\]

  14 weeks

Secondary Outcomes (9)

• Percentage of time in hypoglycemic range

  14 weeks

• Percentage of time in hyperglycemic range

  14 weeks

• Percentage of time in tight range

  14 weeks

• Changes in glycemic variability

  14 weeks

• Icidence of severe hypoglycaemia

  14 weeks

Study Arms (1)

Control-IQ or Smartguard system

EXPERIMENTAL

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

Device: Insulin pump with closed-loop system

Interventions

Insulin pump with closed-loop system DEVICE

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

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

Control-IQ or Smartguard system

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Charles University, Czech Republic: lead
• General University Hospital, Prague: collaborator

Study Sites (1)

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

Prague, Czech Republic, 12808, Czechia

Location

Related Publications (5)

• 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.

  PMID: 23072401 BACKGROUND

• 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.

  PMID: 37743832 BACKGROUND

• 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.

  PMID: 32859607 BACKGROUND

• 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.

  PMID: 27482825 BACKGROUND

• 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.

  PMID: 31530663 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Jan Soupal

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2024
• First Posted: November 29, 2024
• Study Start: December 1, 2020
• Primary Completion: December 1, 2024
• Study Completion: December 31, 2024
• Last Updated: November 29, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)