Android Artificial Pancreas System (Android APS) Versus Control-IQ

NCT05165615 | Unknown FDA Device

• 1 other identifier: CODIAC
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 1

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Percentage of time in target ranges

  3.9-10.0 mmol/L (70-180 mg/dl)

  Up to 28 weeks

Secondary Outcomes (8)

• Percentage of time in hypoglycemic ranges

  Up to 28 weeks

• Percentage of time in hyperglycemic ranges

  Up to 28 weeks

• Changes in glycemic variability

  Up to 28 weeks

• Incidence of severe hypoglycaemia

  Up to 28 weeks

• Changes in glycated haemoglobin (HbA1c)

  Up to 28 weeks

Study Arms (1)

AndroidAPS versus Control-IQ

EXPERIMENTAL

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

Device: Insulin Pump t:slim X2 with Control-IQ technology

Interventions

Insulin Pump t:slim X2 with Control-IQ technology DEVICE

Usage of Insulin pump t:slim X2 with Control-IQ technology in previous users of AndroidAPS

Also known as: Continuous Glucose Monitoring Dexcom G6 system

AndroidAPS versus Control-IQ

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:

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

Sponsors & Collaborators

• Charles University, Czech Republic: lead

Study Sites (1)

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

Prague, Czechia

RECRUITING

Related Publications (6)

• 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

• 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.

  PMID: 22228744 BACKGROUND

• 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.

  PMID: 32354623 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

• 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

• 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

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

  Charles University, Prague

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jan Soupal

CONTACT

+420775654343; jan.soupal@seznam.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 23, 2021
• First Posted: December 21, 2021
• Study Start: December 1, 2020
• Primary Completion: June 30, 2022
• Study Completion: December 31, 2022
• Last Updated: December 21, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)