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

Type 1 Diabetes Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02061488
• Other study ID #: 2013-A01604-41
• Secondary ID: 35RC13_8806_PPA
• Status: Completed
• Phase: N/A
• Start date: March 2014
• Est. completion date: July 2014

Study information

• Verified date: May 2023
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Other:
• open-loop night
During the open-loop night the patient is using his insulin pump as usual
• 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)

Locations

Country	Name	City	State
France	Rennes University Hospital	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

References & Publications (1)

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 S — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Assessment of hypoglycemia occurrence during the night		6 weeks
Secondary	Assessment of area under the curves (70-180mg/dl) during the night		6 weeks
Secondary	Assessment of Low Blood Glucose Index (LBGI), High Blood Glucose Index (HBGI) and CONGA Index		6 weeks
Secondary	Assessment of insulin doses delivered between 9 PM and 8 AM		6 weeks
Secondary	Assessment of number of controller propositions rejected for security reasons		6 weeks
Secondary	Assessment of glucose values during the night (glycemia and interstitial glucose values)		6 weeks