Clinical trial NCT02061488: Assessment of a New Closed-loop Algorithm in Type 1 Diabetes (Saddle Point Model Predictive Control : SP-MPC) (PPA)
Official title: Prospective, Monocentric, Crossover Randomized Trial, to Assess a New Closed-loop Algorithm in Type 1 Diabetes (Saddle Point Model Predictive Control : SP-MPC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Keywords: Artificial pancreas, closed loop glucose control, model predictive control
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2014-02-12
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Assessment of time spent in target range (glycemia between 70 and 145 mg/dl) and in hypoglycemia (glycemia <70 mg/dl), during the night (11 PM to 8 AM)
timeFrame: 6 weeks
Secondary outcomes:
measure: Assessment of time spent above 70 mg/dl, between 70-145 or 145-180 mg/dl and above 180 mg/dl (interstitial glucose) in the late post prandial period (9 to 11 PM) and during the night (11 PM to 8 AM)
timeFrame: 6 weeks
measure: Assessment of hypoglycemia occurrence during the night
timeFrame: 6 weeks
measure: Assessment of area under the curves (70-180mg/dl) during the night
timeFrame: 6 weeks
measure: Assessment of Low Blood Glucose Index (LBGI), High Blood Glucose Index (HBGI) and CONGA Index
timeFrame: 6 weeks
measure: Assessment of insulin doses delivered between 9 PM and 8 AM
timeFrame: 6 weeks
measure: Assessment of number of controller propositions rejected for security reasons
timeFrame: 6 weeks
measure: Assessment of glucose values during the night (glycemia and interstitial glucose values)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Rennes
country: France
facility: Rennes University Hospital
Study officials:
affiliation: Rennes University Hospital
name: Isabelle Guilhem
role: PRINCIPAL_INVESTIGATOR
References:
citation: Guilhem I, Penet M, Paillard A, Carpentier M, Esvant A, Lefebvre MA, Poirier JY. Manual Closed-Loop Insulin Delivery Using a Saddle Point Model Predictive Control Algorithm: Results of a Crossover Randomized Overnight Study. J Diabetes Sci Technol. 2017 Sep;11(5):1007-1014. doi: 10.1177/1932296817717503. Epub 2017 Jul 5.