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OpenTrials
Active, Not Recruiting

NCT Number: NCT06709729

Switch of AndroidAPS to Commercially Available AID Systems

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Prague, Czech Republic, 12808, Czechia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

  1. Percentage of time in target ranges

    Time frame: 14 weeks

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

Secondary outcomes

  1. 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]

  2. 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]

  3. Percentage of time in tight range

    Time frame: 14 weeks

    3.9 mmol/L-7.8 mmol/l [70 mg/dL - 140 mg/dL]

  4. Changes in glycemic variability

    Time frame: 14 weeks

    Expressed as the coefficient of variation

  5. Icidence of severe hypoglycaemia

    Time frame: 14 weeks

    Requiring third-party assistance to treat

  6. Changes in glycated haemoglobin (HbA1c)

    Time frame: 14 weeks

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

  7. 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.

  8. 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.

  9. 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.

Sponsors and collaborators

Lead sponsor

Charles University, Czech Republic

Other

Collaborators

  • General University Hospital, Prague

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Nov 29, 2024
Registry last updated
Nov 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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