Type 1 diabetes Nutritional, Metabolic, Endocrine Insulin-dependent diabetes mellitus
Conditions
Interventions
Patients will receive automated closed loop control of their blood glucose for 24 hours, using the Cambridge algorithm on one study day and the IAP algorithm on another study day and also 24 hours of
Sponsors
Academic Medical Centre (AMC) (Netherlands)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 years or above 2. Diagnosed with type 1 diabetes mellitus (DM) at least 6 months according to the World Health Organisation (WHO) definition 3. Body Mass Index (BMI) < 35 kg/m² 4. Treated by basal-bolus insulin therapy using an external insulin pump for at least 3 months 5. Willing to use insulin aspart and wear a continuous glucose monitoring (CGM) device for the duration of the three study days and undergo all study procedures 6. Trained in carbohydrate counting 7. HbA1c < 10% 8. If patient is on antihypertensive, thyroid, anti-depressant or lipid lowering medication, patient must have stability on the medication for at least 1 month prior to enrollment in the study and for the study duration 9. Signed informed consent form prior to study entry
Exclusion criteria
Exclusion criteria: 1. Patient is pregnant or breast feeding during the period of the study 2. Haematocrit is below 36% (females) and below 38% (males) 3. Symptomatic coronary artery disease (e.g. history of myocardial infarction, history of acute coronary syndrome, history of therapeutic coronary intervention, history of coronary bypass or stenting procedure, stable or unstable angina, positive stress test or catheterisation with coronary blockages > 50%) or congestive heart failure or a history of a cerebrovascular event 4. Patient is using a medication that significantly impacts glucose metabolism (oral steroids) except if stable for at least the last three months and expected to remain stable for the study duration 5. Uncontrolled hypertension with resting blood pressure over 140/90 mmHg 6. Patient is actively enrolled in another clinical trial or took part in a study within 30 days 7. Allergy or adverse reaction to aspart insulin 8. Known adrenal gland problem, pancreatic tumour or insulinoma 9. Current alcohol abuse, substance abuse or severe mental illness, as judged by the investigator 10. Retinopathy except background retinopathy according to eye fundus examination during the last year 11. Known bleeding diathesis or dyscrasia 12. Renal insufficiency with serum creatinine > 150 µmol/L 13. Patient donated blood in the last 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time spent in target range: This is defined as plasma glucose values between 3.9 and 8.0 mmol/L in the basal or late postprandial state (more than 3 hours after breakfast, lunch and dinner) and plasma glucose values between 3.9 and 10.0 mmol/L in the early postprandial state (first 3 hours after breakfast, lunch and dinner) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time spent in hypoglycaemia defined as plasma glucose value 8 mmol/l in the basal or late postprandial state and > 10 mmol/l in the early postprandial state 3. Mean and standard deviation of plasma glucose 4. Time spent in target range defined as CGM glucose values between 3.9 and 8.0 mmol/L in the basal or late postprandial state and CGM glucose values between 3.9 and 10.0 mmol/L in the early postprandial state 5. Time spent in hypoglycaemia defined as CGM glucose value 8 mmol/l in the basal or late postprandial state and > 10 mmol/l in the early postprandial state 7. Mean and standard deviation of CGM glucose values 8. Mean absolute difference between plasma glucose values and CGM glucose values 9. Total number of insulin units infused 10. Median plasma insulin concentration 11. Total duration of treatment in minutes In addition, plasma insulin and glucose concentrations will be used for further modelling studies. | — |
Countries
Austria, France, Germany, Italy, Netherlands, United Kingdom
Outcome results
None listed