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

Primary Purpose

Type 1 Diabetes

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
open-loop night
closed-loop night
Sponsored by
Rennes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Type 1 Diabetes focused on measuring Artificial pancreas, closed loop glucose control, model predictive control

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rennes University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

open-loop night

closed-loop night

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 11, 2014
Last Updated
May 22, 2023
Sponsor
Rennes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02061488
Brief Title
Assessment of a New Closed-loop Algorithm in Type 1 Diabetes (Saddle Point Model Predictive Control : SP-MPC) (PPA)
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
Artificial pancreas, closed loop glucose control, model predictive control

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
open-loop night
Arm Type
Active Comparator
Arm Title
closed-loop night
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
open-loop night
Intervention Description
During the open-loop night the patient is using his insulin pump as usual
Intervention Type
Other
Intervention Name(s)
closed-loop night
Intervention Description
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)
Primary Outcome Measure Information:
Title
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)
Description
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 Outcome Measure Information:
Title
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)
Description
Assessment of hypoglycemia and hyperglycemia cases, average glycemic balance, glycemic variability, insulin doses
Time Frame
6 weeks
Title
Assessment of hypoglycemia occurrence during the night
Time Frame
6 weeks
Title
Assessment of area under the curves (70-180mg/dl) during the night
Time Frame
6 weeks
Title
Assessment of Low Blood Glucose Index (LBGI), High Blood Glucose Index (HBGI) and CONGA Index
Time Frame
6 weeks
Title
Assessment of insulin doses delivered between 9 PM and 8 AM
Time Frame
6 weeks
Title
Assessment of number of controller propositions rejected for security reasons
Time Frame
6 weeks
Title
Assessment of glucose values during the night (glycemia and interstitial glucose values)
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isabelle Guilhem
Organizational Affiliation
Rennes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rennes University Hospital
City
Rennes
ZIP/Postal Code
35033
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
28677416
Citation
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.
Results Reference
result

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

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