3rd Department of Internal Medicine, 1st Faculty of Medicine, Charles University
Prague, Czech Republic, 12808, Czechia
NCT Number: NCT06709729
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.
This study is active but is not currently recruiting participants.
18 year and older
All sexes
Interventional
Not applicable
Prague, Czech Republic, 12808, Czechia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 14 weeks
3.9-10.0 mmol/L [70-180 mg/dL]
Time frame: 14 weeks
<3.9 mmol/L [70 mg/dL] and <3.0 mmol/L [54 mg/dL]
Time frame: 14 weeks
>10,0 mmol/L [180 mg/dL] and >13,9 mmol/L [250 mg/dL]
Time frame: 14 weeks
3.9 mmol/L-7.8 mmol/l [70 mg/dL - 140 mg/dL]
Time frame: 14 weeks
Expressed as the coefficient of variation
Time frame: 14 weeks
Requiring third-party assistance to treat
Time frame: 14 weeks
Differences between HbA1c values in the initial period and after follow-up
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.
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.
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.
Charles University, Czech Republic
Other
Switch of Open-source Automated Insulin Delivery System - AndroidAPS to Commercially Available AID Systems in Type 1 Diabetes: the Extension of the CODIAC Study
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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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