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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT02061488
First received: February 11, 2014
Last updated: July 22, 2014
Last verified: July 2014
  Purpose

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


Condition Intervention
Type 1 Diabetes
Other: open-loop night
Other: closed-loop night

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
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)

Resource links provided by NLM:


Further study details as provided by Rennes University Hospital:

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) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Assessment of hypoglycemia and hyperglycemia cases, average glycemic balance, glycemic variability, insulin doses

  • Assessment of hypoglycemia occurrence during the night [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Assessment of area under the curves (70-180mg/dl) during the night [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Assessment of Low Blood Glucose Index (LBGI), High Blood Glucose Index (HBGI) and CONGA Index [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Assessment of insulin doses delivered between 9 PM and 8 AM [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Assessment of number of controller propositions rejected for security reasons [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Assessment of glucose values during the night (glycemia and interstitial glucose values) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: March 2014
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02061488

Locations
France
Rennes University Hospital
Rennes, France, 35033
Sponsors and Collaborators
Rennes University Hospital
Investigators
Principal Investigator: Isabelle Guilhem Rennes University Hospital
  More Information

No publications provided

Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT02061488     History of Changes
Other Study ID Numbers: 2013-A01604-41, 35RC13_8806_PPA
Study First Received: February 11, 2014
Last Updated: July 22, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by Rennes University Hospital:
Artificial pancreas, closed loop glucose control, model predictive control

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on August 21, 2014