An interventional study of open-loop night and closed-loop night in Type 1 Diabetes, sponsored by Rennes University Hospital. Completed at 1 site in France. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-05-24.
Sponsored by Rennes University Hospital · Not applicable, Interventional, and Other
The purpose of the study is to assess a new closed-loop algorithm in type 1 diabetes (Saddle Point Model Predictive Control : SP-MPC)
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 10 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Rennes University Hospital is the lead sponsor of 440 studies on the registry; 51 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other: open-loop night
Other: closed-loop night
During the open-loop night the patient is using his insulin pump as usual
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)
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
Time frame: 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)
Assessment of hypoglycemia and hyperglycemia cases, average glycemic balance, glycemic variability, insulin doses
Time frame: 6 weeks
Assessment of hypoglycemia occurrence during the night
Time frame: 6 weeks
Assessment of area under the curves (70-180mg/dl) during the night
Time frame: 6 weeks
Assessment of Low Blood Glucose Index (LBGI), High Blood Glucose Index (HBGI) and CONGA Index
Time frame: 6 weeks
Assessment of insulin doses delivered between 9 PM and 8 AM
Time frame: 6 weeks
Assessment of number of controller propositions rejected for security reasons
Time frame: 6 weeks
Assessment of glucose values during the night (glycemia and interstitial glucose values)
Time frame: 6 weeks
This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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Rennes University Hospital