Diabetes Mellitus, Type 1
Conditions
Keywords
Continuous Glucose Monitoring, Insulin Pump, Closed-loop hybrid system
Brief summary
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.
Interventions
DEVICEInsulin Pump t:slim X2 with Control-IQ technology
Usage of Insulin pump t:slim X2 with Control-IQ technology in previous users of AndroidAPS
Sponsors
Charles University, Czech Republic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
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
* severe noncompliance * lactation, pregnancy, intending to become pregnant during study * use of medication with effects on carbohydrate metabolism
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of time in target ranges | Up to 28 weeks | 3.9-10.0 mmol/L (70-180 mg/dl) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of time in hyperglycemic ranges | Up to 28 weeks | \>10.0 mmol/L (180 mg/dl) and \>13.9 mmol/L (250 mg/dl) |
| Changes in glycemic variability | Up to 28 weeks | Expressed as the coefficient of variation |
| Incidence of severe hypoglycaemia | Up to 28 weeks | Requiring third-party assistance to treat |
| Percentage of time in hypoglycemic ranges | Up to 28 weeks | \<3.9 mmol/L (70 mg/dl) and \<3.0 mmol/L (54 mg/dl) |
| Hypoglycemia Attitudes and Behavior Scale (HABS) | Up to 28 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. |
| Diabetes Distress Scale (DDS) | Up to 28 weeks | 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. |
| The 5-item World Health Organization well-being index (WHO-5 index) | Up to 28 weeks | 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). |
| Changes in glycated haemoglobin (HbA1c) | Up to 28 weeks | Differences between HbA1c values in the initial period and after follow-up |
Countries
Czechia
Contacts
Primary ContactJan Soupal
Outcome results
None listed