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

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

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

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Other: open-loop night; Other: closed-loop night

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Rennes, France, 35033
    • Rennes University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: open-loop night	Other: open-loop night; During the open-loop night the patient is using his insulin pump as usual
Experimental: closed-loop night	Other: closed-loop night; 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)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Rennes University Hospital
• Investigators: Principal Investigator: Isabelle Guilhem, Rennes University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: February 11, 2014
• First Submitted That Met QC Criteria: February 11, 2014
• First Posted (Estimate): February 12, 2014

Study Record Updates

• Last Update Posted (Actual): May 24, 2023
• Last Update Submitted That Met QC Criteria: May 22, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Artificial pancreas, closed loop glucose control, model predictive control
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: 2013-A01604-41; 35RC13_8806_PPA (Other Identifier: Rennes University Hospital)