Type 1 Diabetes
Conditions
Keywords
Artificial pancreas, closed loop glucose control, model predictive control
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.
Interventions
OTHERopen-loop night
During the open-loop night the patient is using his insulin pump as usual
OTHERclosed-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)
Sponsors
Rennes University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 6 weeks | 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
| Measure | Time frame | Description |
|---|---|---|
| Assessment of hypoglycemia occurrence during the night | 6 weeks | — |
| Assessment of area under the curves (70-180mg/dl) during the night | 6 weeks | — |
| Assessment of Low Blood Glucose Index (LBGI), High Blood Glucose Index (HBGI) and CONGA Index | 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) | 6 weeks | Assessment of hypoglycemia and hyperglycemia cases, average glycemic balance, glycemic variability, insulin doses |
| Assessment of number of controller propositions rejected for security reasons | 6 weeks | — |
| Assessment of glucose values during the night (glycemia and interstitial glucose values) | 6 weeks | — |
| Assessment of insulin doses delivered between 9 PM and 8 AM | 6 weeks | — |
Countries
France
Outcome results
None listed