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

Not Applicable

Completed

• Conditions: Type 1 Diabetes
• Interventions: Other: open-loop night; Other: closed-loop night

• Registration Number: NCT02061488
• Lead Sponsor: Rennes University Hospital

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.

Study Timeline

• Study First Submitted: 2014-02-11
• Study First Submitted QC: 2014-02-11
• Study First Posted: 2014-02-12
• Study Start: 2014-03
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-22
• Last Update Posted: 2023-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
open-loop night	open-loop night	-
closed-loop night	closed-loop night	-

Primary Outcome Measures

Name	Time	Method
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)	6 weeks	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

Secondary Outcome Measures

Name	Time	Method
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 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)	6 weeks	Assessment of hypoglycemia and hyperglycemia cases, average glycemic balance, glycemic variability, insulin doses
Assessment of hypoglycemia occurrence during the night	6 weeks
Assessment of glucose values during the night (glycemia and interstitial glucose values)	6 weeks
Assessment of number of controller propositions rejected for security reasons	6 weeks

Trial Locations

Locations (1)

Rennes University Hospital; 🇫🇷 Rennes, France