Portable Artificial Pancreas Applied for Youth and Adolescents, PAPAYA 1

Conditions: Diabetes Mellitus Type 1 / Diabetes
10018424

Registration Number: NL-OMON51613

Lead Sponsor: Inreda Diabetic B.V.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

- Diagnosed with Type 1 Diabetes
- 12-18 years old
- Treated with insulin therapy for at least 6 months

Exclusion Criteria

- Impaired awareness of hypoglycaemia (score >= 4) according to Gold and/or
Clarke questionnaire
- BMI >= 35 kg/m2
- Pregnancy and/or breastfeeding
- HbA1c > 97 mmol/mol (11.0%)
- Use of acetaminophen (paracetamol) during the open loop or closed-loop period
- Limited ability to see, hear or feel the alarm signals of the closed-loop
system
- Unwillingness to act in response to the alarm signals
- Living alone during the night during the closed-loop period
- Expected poor internet connectivity regarding 24/7 tele monitoring

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study parameter is the percentage of time spent in the target range<br /><br>(3.9-10.0 mmol/L), which will be compared between the open and closed-loop<br /><br>periods for each patient.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The safety parameters are:<br /><br>• The proportion of time spent in the following categories:<br /><br>o Hypoglycaemia (< 3.9 mmol/L);<br /><br>o Hypoglycaemia (< 3.0 mmol/L);<br /><br>o Hyperglycaemia (> 10.0 mmol/L);<br /><br>o Hyperglycaemia (> 13.9 mmol/L).<br /><br><br /><br>Secondary performance parameters are:<br /><br>• Mean or median sensor glucose concentration;<br /><br>• Glycaemic variability;<br /><br>• Day and night mean or median sensor glucose concentration;<br /><br>• Day and night time spent in hypo-, hyper- and euglycaemia.<br /><br><br /><br>• Percentage of time that the closed-loop algorithm is active (closed-loop<br /><br>period only).<br /><br><br /><br>• Expectations of the closed-loop system and treatment satisfaction scores in<br /><br>patients and their parents (expectations for closed-loop only). </p><br>