Assessment of a New Closed-loop Algorithm in Type 1 Diabetes (Saddle Point Model Predictive Control : SP-MPC) (PPA)
NCT ID: NCT02061488
Last Updated: 2023-05-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
10 participants
INTERVENTIONAL
2014-03-31
2014-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
NONE
Study Groups
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open-loop night
open-loop night
During the open-loop night the patient is using his insulin pump as usual
closed-loop night
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)
Interventions
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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)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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Rennes University Hospital
OTHER
Responsible Party
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Principal Investigators
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Isabelle Guilhem
Role: PRINCIPAL_INVESTIGATOR
Rennes University Hospital
Locations
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Rennes University Hospital
Rennes, , France
Countries
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References
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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.
Other Identifiers
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35RC13_8806_PPA
Identifier Type: OTHER
Identifier Source: secondary_id
2013-A01604-41
Identifier Type: -
Identifier Source: org_study_id
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