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

NCT ID: NCT05165615

Last Updated: 2021-12-21

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

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-01

Study Completion Date

2022-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 1

Keywords

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Continuous Glucose Monitoring Insulin Pump Closed-loop hybrid system

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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AndroidAPS versus Control-IQ

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

Group Type EXPERIMENTAL

Insulin Pump t:slim X2 with Control-IQ technology

Intervention Type DEVICE

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

Interventions

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Insulin Pump t:slim X2 with Control-IQ technology

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

Intervention Type DEVICE

Other Intervention Names

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Continuous Glucose Monitoring Dexcom G6 system

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Charles University, Czech Republic

OTHER

Sponsor Role lead

Responsible Party

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Jan Soupal, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jan Soupal

Role: PRINCIPAL_INVESTIGATOR

Charles University, Prague

Locations

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

Prague, , Czechia

Site Status RECRUITING

Countries

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Czechia

Central Contacts

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Jan Soupal

Role: CONTACT

Phone: +420775654343

Email: [email protected]

Facility Contacts

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Jan Soupal

Role: primary

References

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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)

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.

Reference Type BACKGROUND
PMID: 22228744 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32354623 (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)

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)

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)

Other Identifiers

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CODIAC

Identifier Type: -

Identifier Source: org_study_id