Status:
COMPLETED
Algorithm to Control Postprandial, Post Exercise and Night Glucose Excursions in a Portable Closed Loop Format,
Lead Sponsor:
J.H. DeVries
Collaborating Sponsors:
Rijnstate Hospital
Inreda Diabetic B.V.
Conditions:
Diabetes Mellitus, Type 1
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
In previous studies, the investigators tested the feasibility of a bi-hormonal reactive closed loop system without mealtime announcement. This system for automated control of blood glucose in patients...
Eligibility Criteria
Inclusion
- Diagnosed with diabetes mellitus type 1;
- Treated with SAP or CSII for a minimum of 6 months;
- Willing and able to sign informed consent.
Exclusion
- Impaired awareness of hypoglycemia (score ≥ 4) according to Gold and/or Clarke questionnaire;
- BMI \> 35 kg/m2;
- HbA1c \> 97 mmol/mol (=11.0 %);
- Use of heparin, coumarin derivatives or oral corticosteroids;
- Use of acetaminophen during the open loop or closed loop period, as this may influence the sensor glucose measurements;
- Limited ability to see, and to hear or feel alarm signals of the closed loop system;
- Skin condition prohibiting needle insertion;
- Pregnancy and/or breastfeeding;
- Living alone during the night during the closed loop period (the patient may ask someone to stay over temporarily);
- Expected poor connectivity with internet regarding 24/7 tele monitoring;
- Any condition that the local investigator feels would have interfere with trial participation or the evaluation of the results
Key Trial Info
Start Date :
March 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 12 2019
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT03858062
Start Date
March 10 2019
End Date
September 12 2019
Last Update
October 22 2019
Active Locations (2)
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1
Rijnstate Hospital
Arnhem, Gelderland, Netherlands, 6815 AD
2
Academic Medical Center
Amsterdam, North Holland, Netherlands, 1105 AZ