Objective of the study is the comparison of two previously developed computeralgorithms for the artificial pancreas (closed loop). One algorithm developed by a researchgroup in Cambridge UK, and an algorithm developed by research groups in Padua and…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
* Time spent in hypoglycaemia defined as plasma glucose value <3.9 mmol/l
* Time spent in hyperglycaemia, defined as plasma glucose value >8 mmol/l in
the basal or late postprandial state and >10 mmol/l in the early postprandial
state
* Mean and standard deviation of plasma glucose
* 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
* Time spent in hypoglycaemia defined as CGM glucose value <3.9 mmol/l
* Time spent in hyperglycaemia, defined as CGM glucose value >8 mmol/l in the
basal or late postprandial state and >10 mmol/l in the early postprandial state
* Mean and standard deviation of CGM glucose values
* Total number of insulin units infused
* Median plasma insulin concentration
* Total duration of treatment in minutes
Background summary
Patients with type 1 diabetes must use the optimal amount of insulin to prevent
excessive swings in blood glucose. This requires the patient to be vigilant
about their own glucose levels at all times. Finger pricks must be done to
determine blood glucose and the patient should determine the appropriate amount
of insulin administration in relation to this glucose level and expected food
intake and physical activity. This can be tricky, and scientists have been
looking for a way to automate the measurement of blood glucose and the
administration of insulin. The device that does this is known as the artificial
pancreas. The artificial pancreas consists of a subcutaneous continous glucose
sensor which measures blood glucose, an insulin pump which provides insulin and
a computer algorithm which receives the glucose measurements and controls the
pump to administer appropriate amounts of insulin without the need of patient
intervention.
Study objective
Objective of the study is the comparison of two previously developed
computeralgorithms for the artificial pancreas (closed loop). One algorithm
developed by a researchgroup in Cambridge UK, and an algorithm developed by
research groups in Padua and Pavia, Italy.
The algorithms will be compared to open loop control (the use of continuous
subcutaneous insulin therapy / insulin pump). Performance of the algorithms in
terms of keeping the patient in the euglycaemic range will be assessed, also
after the meal and following exercise.
Study design
Patients will be admitted to the clinical research ward 3 times, during which
they will randomly be assigned to undergo all treatment arms of the study in a
cross-over design.
Intervention
The intervention consists of the regulation of plasma glucose by means of the
artificial pancreas. The three treatment arms are: 1. closed loop with the
algorithm from Cambridge 2. closed loop with the algorithm from padua-pavia 3.
open loop control with CSII/insulin pump.
Study burden and risks
In total there are 7 visits which require patients to come to the hospital,
they are listed here:
1. Inclusion visit (1 hour)
2. pre-admission visit for placement of glucose sensor (20 minutes)
3. admission 1 (24 hours)
4. pre-admission visit for placement of glucose sensor (20 minutes)
5. admission 2 (24 hours)
6. pre-admission visit for placement of glucose sensor (20 minutes)
7. admission 3 (24 hours)
This research may involve the following side effects:
- Bruising by placement of the intravenous catheter, the subcutaneous glucose
sensor or the insulin catheter.
- Inflammation or skin irritation at the insertion site of the intravenous
catheter, the subcutaneous glucose sensor or the insulin catheter.
- hypoglycaemia
- hyperglycaemia
Hypo- or hyperglycaemia during the investigation exceeding pre-determined
safety limits will be corrected by the investigator.
Postbus 22660
1100DD Amsterdam
NL
Postbus 22660
1100DD Amsterdam
NL
Listed location countries
Age
Inclusion criteria
aged 18 years or above
diagnosed with Type 1 diabetes mellitus at least 6 months according to the WHO definition
Body Mass Index (BMI) <35 kg/m²
treated by basal-bolus insulin therapy using an external insulin pump for at least 3 months
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
Exclusion criteria
Patient is pregnant, or breast feeding during the period of the study
Symptomatic coronary artery disease
Patient is using a medication that significantly impacts glucose metabolism
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL32634.018.10 |