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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prospective, Monocentric, Crossover Randomized Trial, to Assess a New Closed-loop Algorithm in Type 1 Diabetes (Saddle Point Model Predictive Control : SP-MPC)

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Other: open-loop night
* Other: closed-loop night


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: open-loop night<br> | Other: open-loop night<br>* During the open-loop night the patient is using his insulin pump as usual<br>|
| Experimental: closed-loop night<br> | Other: closed-loop night<br>* During the closed-loop night glucose values measured by the sensor are collected every 15 minutes. The data are entered into the SP-MPC controler that calculate the insulin dose to be delivered. A diabetologist validates the insulin dose before the infusion (manually bolus infusion)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Assessment of 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 | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Assessment of hypoglycemia and hyperglycemia cases, average glycemic balance, glycemic variability, insulin doses | 6 weeks | 
| Assessment of hypoglycemia occurrence during the night |  | 6 weeks | 
| Assessment of area under the curves (70-180mg/dl) during the night |  | 6 weeks | 
| Assessment of Low Blood Glucose Index (LBGI), High Blood Glucose Index (HBGI) and CONGA Index |  | 6 weeks | 
| Assessment of insulin doses delivered between 9 PM and 8 AM |  | 6 weeks | 
| Assessment of number of controller propositions rejected for security reasons |  | 6 weeks | 
| Assessment of glucose values during the night (glycemia and interstitial glucose values) |  | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Artificial pancreas, closed loop glucose control, model predictive control