Switch of AndroidAPS to Commercially Available AID Systems

November 25, 2024 updated by: Charles University, Czech Republic

Switch of Open-source Automated Insulin Delivery System - AndroidAPS to Commercially Available AID Systems in Type 1 Diabetes: the Extension of the CODIAC Study

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

41

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • Prague 2, Czech Republic, 12808
        • 3rd Department of Internal Medicine, 1st Faculty of Medicine, Charles University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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)
Device: 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
Other Names:
  • Insulin pump t:slim X2 with Control-IQ technology
  • Insulin pump MiniMed 780G with Smartguard technology in previous users of AndroidAPS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of time in target ranges
Time Frame: 14 weeks
3.9-10.0 mmol/L [70-180 mg/dL]
14 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of time in hypoglycemic range
Time Frame: 14 weeks
<3.9 mmol/L [70 mg/dL] and <3.0 mmol/L [54 mg/dL]
14 weeks
Percentage of time in hyperglycemic range
Time Frame: 14 weeks
>10,0 mmol/L [180 mg/dL] and >13,9 mmol/L [250 mg/dL]
14 weeks
Percentage of time in tight range
Time Frame: 14 weeks
3.9 mmol/L-7.8 mmol/l [70 mg/dL - 140 mg/dL]
14 weeks
Changes in glycemic variability
Time Frame: 14 weeks
Expressed as the coefficient of variation
14 weeks
Icidence of severe hypoglycaemia
Time Frame: 14 weeks
Requiring third-party assistance to treat
14 weeks
Changes in glycated haemoglobin (HbA1c)
Time Frame: 14 weeks
Differences between HbA1c values in the initial period and after follow-up
14 weeks
Hypoglycemia Attitudes and Behavior Scale (HABS)
Time Frame: 14 weeks
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.
14 weeks
Diabetec distress as assessed by validated questionnaire
Time Frame: 14 weeks
The DDS17 yields a total diabetes distress score plus 4 subscale scores, each addressing a different kind of distress - Emotional Burden, Physician Distress, Regimen Distress, Interpersonal Distress. Scores in total and each subscales range between 1-21, higher scores denote higher distress.
14 weeks
The 5-item World Health Organization well-being index as assessed by validated questionnaire
Time Frame: 14 weeks
This questionnaire contains in total 5 questions. Scores in total range between 0-25, higher scores denote higher quality of life.
14 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charles University, Czech Republic

Collaborators

General University Hospital in Prague

Investigators

  • Principal Investigator: Jan Soupal, 3rd Department of Internal Medicine, 1st Faculty of Medicine, Charles University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2020

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

November 2, 2024

First Submitted That Met QC Criteria

November 25, 2024

First Posted (Actual)

November 29, 2024

Study Record Updates

Last Update Posted (Actual)

November 29, 2024

Last Update Submitted That Met QC Criteria

November 25, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CODIAC Extension

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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