Diabetes Mellitus, Type 1
Conditions
Keywords
Insulin Pump, Closed-loop hybrid system, Continuous Glucose Monitoring, Automated Insulin Delivery
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.
Interventions
DEVICEInsulin 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
Sponsors
General University Hospital, Prague
Charles University, Czech Republic
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of time in target ranges | 14 weeks | 3.9-10.0 mmol/L \[70-180 mg/dL\] |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of time in hyperglycemic range | 14 weeks | \>10,0 mmol/L \[180 mg/dL\] and \>13,9 mmol/L \[250 mg/dL\] |
| Percentage of time in tight range | 14 weeks | 3.9 mmol/L-7.8 mmol/l \[70 mg/dL - 140 mg/dL\] |
| Changes in glycemic variability | 14 weeks | Expressed as the coefficient of variation |
| Icidence of severe hypoglycaemia | 14 weeks | Requiring third-party assistance to treat |
| Percentage of time in hypoglycemic range | 14 weeks | \<3.9 mmol/L \[70 mg/dL\] and \<3.0 mmol/L \[54 mg/dL\] |
| 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. |
| Changes in glycated haemoglobin (HbA1c) | 14 weeks | Differences between HbA1c values in the initial period and after follow-up |
Countries
Czechia
Outcome results
None listed