Switch of AndroidAPS to Commercially Available AID Systems

Not Applicable

Active, not recruiting

• Conditions: Diabetes Mellitus, Type 1

• Registration Number: NCT06709729
• Lead Sponsor: Charles University, Czech Republic

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-01
• Status Verified: 2024-09
• Study First Submitted: 2024-11-02
• Study First Submitted QC: 2024-11-25
• Last Update Submitted: 2024-11-25
• Study First Posted: 2024-11-29
• Last Update Posted: 2024-11-29
• Primary Completion: 2024-12-01
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 41

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Percentage of time in target ranges	14 weeks	3.9-10.0 mmol/L \[70-180 mg/dL\]

Secondary Outcome Measures

Name	Time	Method
Percentage of time in hypoglycemic range	14 weeks	\<3.9 mmol/L \[70 mg/dL\] and \<3.0 mmol/L \[54 mg/dL\]
Percentage of time in tight range	14 weeks	3.9 mmol/L-7.8 mmol/l \[70 mg/dL - 140 mg/dL\]
Percentage of time in hyperglycemic range	14 weeks	\>10,0 mmol/L \[180 mg/dL\] and \>13,9 mmol/L \[250 mg/dL\]
Changes in glycemic variability	14 weeks	Expressed as the coefficient of variation
Icidence of severe hypoglycaemia	14 weeks	Requiring third-party assistance to treat
Changes in glycated haemoglobin (HbA1c)	14 weeks	Differences between HbA1c values in the initial period and after follow-up
Hypoglycemia Attitudes and Behavior Scale (HABS)	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.
Diabetec distress as assessed by validated questionnaire	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.
The 5-item World Health Organization well-being index as assessed by validated questionnaire	14 weeks	This questionnaire contains in total 5 questions. Scores in total range between 0-25, higher scores denote higher quality of life.

Trial Locations

Locations (1)

3rd Department of Internal Medicine, 1st Faculty of Medicine, Charles University; 🇨🇿 Prague 2, Czech Republic