The aim of the investigator's study is to compare two different closed loop hybrid systems - certified Control-IQ and noncertified AndroidAPS in adult patients with Type 1 Diabetes (T1D), who had been using AndroidAPS previously from their own decision, during 12 weeks of follow-up.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
20
Usage of Insulin pump t:slim X2 with Control-IQ technology in previous users of AndroidAPS
3rd Department of Internal Medicine, 1st Faculty of Medicine, Charles University
Prague, Czechia
RECRUITINGPercentage of time in target ranges
3.9-10.0 mmol/L (70-180 mg/dl)
Time frame: Up to 28 weeks
Percentage of time in hypoglycemic ranges
\<3.9 mmol/L (70 mg/dl) and \<3.0 mmol/L (54 mg/dl)
Time frame: Up to 28 weeks
Percentage of time in hyperglycemic ranges
\>10.0 mmol/L (180 mg/dl) and \>13.9 mmol/L (250 mg/dl)
Time frame: Up to 28 weeks
Changes in glycemic variability
Expressed as the coefficient of variation
Time frame: Up to 28 weeks
Incidence of severe hypoglycaemia
Requiring third-party assistance to treat
Time frame: Up to 28 weeks
Changes in glycated haemoglobin (HbA1c)
Differences between HbA1c values in the initial period and after follow-up
Time frame: Up to 28 weeks
Hypoglycemia Attitudes and Behavior Scale (HABS)
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: Up to 28 weeks
Diabetes Distress Scale (DDS)
This validated questionnaire assess diabetes-related emotional stress. This 17-item tool uses the Likert scales from 1 to 6. Total score is from 17 to 102, while higher total score means worse outcome.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Up to 28 weeks
The 5-item World Health Organization well-being index (WHO-5 index)
This validated questionnaire contains in total 5 questions with Likert scales from 5 to 0. Total score is multiplied by 4 to give a final score ranging from 0 to 100, higher score denote higher quality of life (better outcome).
Time frame: Up to 28 weeks