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

N/ACompletedNCT02061488

Rennes University Hospital10 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Type 1 Diabetes

Interventions

open-loop nightOTHER

During the open-loop night the patient is using his insulin pump as usual

closed-loop nightOTHER

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)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Rennes University Hospital

Rennes, France

Outcomes

Primary Outcomes

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

Time frame: 6 weeks

Secondary Outcomes

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

Time frame: 6 weeks

Assessment of hypoglycemia occurrence during the night

Time frame: 6 weeks

Assessment of area under the curves (70-180mg/dl) during the night

Time frame: 6 weeks

Assessment of Low Blood Glucose Index (LBGI), High Blood Glucose Index (HBGI) and CONGA Index

Time frame: 6 weeks

Assessment of insulin doses delivered between 9 PM and 8 AM

Time frame: 6 weeks

Assessment of number of controller propositions rejected for security reasons

Time frame: 6 weeks

Assessment of glucose values during the night (glycemia and interstitial glucose values)

Time frame: 6 weeks

Data from ClinicalTrials.gov

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