Assessment of a New Closed-loop Algorithm in Type 1 Diabetes (Saddle Point Model Predictive Control : SP-MPC) (PPA)

Rennes University Hospital

Status

Completed

Conditions

Type 1 Diabetes

Treatments

Other: open-loop night

Other: closed-loop night

Study type

Interventional

Funder types

Other

Identifiers

NCT02061488

35RC13_8806_PPA (Other Identifier)

2013-A01604-41

Details and patient eligibility

About

The purpose of the study is to assess a new closed-loop algorithm in type 1 diabetes (Saddle Point Model Predictive Control : SP-MPC)

Full description

Ten patients will be assessed during a closed-loop night and an open-loop night in random order.

The primary objective is to assess the ability of SP-MPC controler to maintain euglycemia and avoid hypoglycaemia during the night, compared to open loop in type 1 diabetic patients treated by insulin pump.

Enrollment

10 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients with type 1 diabetes (C peptide negative) :
18 to 70 year old,
with type 1 diabetes for more than 3 years,
treated by insulin pump for more than 3 months,
with previous CGM holter allowing preliminary settting of some of the SP-MPC parameters
able to provide written informed consent.

Exclusion criteria

pregnancy or breastfeeding,
severe non stabilized diabetic retinopathy,
cardiovascular event in the previous 6 months,
infectious diseases with recent fever,
anemia (hemoglobin < 11g/l),
HbA1c > 10%,
Current or recent (less than 4 weeks) oral or injectable corticosteroid treatment,
creatinine clearance <40ml/mn,
chronic alcoholism (weekly consumption of alcohol > 280g for men and > 140g for women),
adults legally protected (under judicial protection, guardianship, or supervision), persons deprived of their liberty