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Diabetes Mellitus, Type 1CODIACNCT05165615

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

A study of Diabetes Mellitus, Type 1, run by Charles University, Czech Republic at 1 site in Czechia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus, Type 1
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteCzechia
Study dates
1 Dec 2020to 31 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Jan Soupal contact

+420775654343

jan.soupal@seznam.cz

Czechia1 site, 1 recruiting

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

    Prague

    Jan Soupal, +420775654343, jan.soupal@seznam.cz

    Recruiting

Other trials in Czechia

About this study

Official title: Comparison of the Two Different Closed-loop Hybrid Systems - AndroidAPS and Control-IQ in Patients With Type 1 Diabetes

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.

Being tested
Insulin Pump t:slim X2 with Control-IQ technology
Keywords
Continuous Glucose Monitoring, Insulin Pump, Closed-loop hybrid system
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Insulin Pump t:slim X2 with Control-IQ technologyDevice

    Also called Continuous Glucose Monitoring Dexcom G6 system

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

Study groups in NCT05165615
Study groupRoleWhat they receive
AndroidAPS versus Control-IQExperimentalPatients with use of the Control-IQ system (closed-loop hybrid system) and previous users of AndroidAPS (closed-loop hybrid system)
Receives: Device: Insulin Pump t:slim X2 with Control-IQ technology

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of time in target ranges

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

    Measured: Up to 28 weeks

Secondary outcomes (8)

  1. Percentage of time in hypoglycemic ranges

    <3.9 mmol/L (70 mg/dl) and <3.0 mmol/L (54 mg/dl)

    Measured: Up to 28 weeks

  2. Percentage of time in hyperglycemic ranges

    >10.0 mmol/L (180 mg/dl) and >13.9 mmol/L (250 mg/dl)

    Measured: Up to 28 weeks

  3. Changes in glycemic variability

    Expressed as the coefficient of variation

    Measured: Up to 28 weeks

  4. Incidence of severe hypoglycaemia

    Requiring third-party assistance to treat

    Measured: Up to 28 weeks

  5. Changes in glycated haemoglobin (HbA1c)

    Differences between HbA1c values in the initial period and after follow-up

    Measured: Up to 28 weeks

  6. Hypoglycemia Attitudes and Behavior Scale (HABS)

    This validated questionnaire contains in total 14 questions that highlights two critical dimensions of hypoglycemia-related concerns (anxiety and avoidance) and one positive dimension (confidence). 14 items use Likert scales from 1 to 5, total score from 14 to 70, the higher total score means worse outcome.

    Measured: Up to 28 weeks

  7. Diabetes Distress Scale (DDS)

    This validated questionnaire assess diabetes-related emotional stress. This 17-item tool uses the Likert scales from 1 to 6. Total score is from 17 to 102, while higher total score means worse outcome.

    Measured: Up to 28 weeks

  8. The 5-item World Health Organization well-being index (WHO-5 index)

    This validated questionnaire contains in total 5 questions with Likert scales from 5 to 0. Total score is multiplied by 4 to give a final score ranging from 0 to 100, higher score denote higher quality of life (better outcome).

    Measured: Up to 28 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Dec 2021
  2. Study start1 Dec 2020
  3. Primary completion30 Jun 2022 (estimated)
  4. Study completion31 Dec 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05165615
Sponsor's protocol ID
CODIAC
Acronym
CODIAC
Status last verified
Dec 2021
First submitted
23 Nov 2021
Last updated
21 Dec 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 23072401

  • 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.

    PubMed 22228744

  • 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.

    PubMed 32354623

  • 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.

    PubMed 31530663

  • 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.

    PubMed 27482825

  • 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.

    PubMed 32859607

  • 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.

    PubMed 37743832

Questions about this trial

What is this clinical trial studying?

A study of Diabetes Mellitus, Type 1, run by Charles University, Czech Republic at 1 site in Czechia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jan Soupal (+420775654343, jan.soupal@seznam.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of time in target ranges (time frame: Up to 28 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05165615, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2021.

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