To measure serum insulin and glucose profiles after bolus insulin administration by a patch-pump versus a catheter based pump, reproducibility of these insulin profiles and the effect of catheter wear-time on these profiles in patients with type 1…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint will be time to peak serum insulin levels following
administration of the mealtime insulin bolus with CP and PP, and coefficient of
variation (CV) of basal and postprandial insulin levels after CP and PP.
Secondary outcome
Secondary endpoints will include postprandial glucose excursions, early insulin
t50% and area under the curve for insulin levels, Maximum concentration of
insulin levels, delta baseline to peak in insulin levels and coefficient of
variation of basal insulin levels. Of the secondary endpoints listed above the
same will be determined for glucose levels after administration of mealtime
bolus.
Background summary
Most closed loop approaches rely on subcutaneous administration of insulin by
means of conventional insulin pumps (i.e. pumps with a catheter). Until
recently all insulin pumps consisted of a needle inserted into the subcutaneous
tissue, a pump (containing the insulin, electronic, pump and batteries) and a
catheter connecting these two parts. Recently patch-pumps were developed, to be
carried directly on the skin, without the need to insert a needle manually and
without a visible catheter. Internally these patch-pump still employ a catheter
of about 50 mm; however, substantially less than the 600 mm of catheter tubing
used with catheter based pumps. For Artificial Pancreas (AP) development it is
highly relevant to know if patch-pumps and conventional pumps have different
insulin absorption rates and reproducibility of insulin absorption. Recent
evidence suggests that the duration of the insulin catheter usage (wear-time)
also influences the speed of insulin absorption from the subcutaneous tissue,
as the time to maximal insulin levels seems to move forward in time with a
longer wear-time.
Study objective
To measure serum insulin and glucose profiles after bolus insulin
administration by a patch-pump versus a catheter based pump, reproducibility of
these insulin profiles and the effect of catheter wear-time on these profiles
in patients with type 1 diabetes.
Study design
The study will be a randomised open-label trial with a cross-over design.
Intervention
The study will consist of the measurement of glucose and serum insulin levels
at baseline and following a meal. Patients with Type 1 diabetes will come in
for two blocks of visits: one block of two visits (48 h apart) while wearing
the Omnipod Insulin Pump (PP) and one block of two visits while wearing a
Medtronic Paradigm Pump (CP). The visit blocks will be in random order, using a
crossover design. For study visits, patients will report to the clinical
research unit in a fasting state in the early morning hours and blood sampling
for insulin levels will start to record baseline values. Patients will then be
served an individually standardized breakfast and mealtime insulin bolus ( at
least 6 U).
The two visits in a given block will be 48 hours apart. We will use the second
visits in each block to perform a separate analysis investigating the effect of
catheter wear-time.
Study burden and risks
Patients will visit the clinical research center (CRC) for an inclusion visit;
this visit will take approximately 1 hour to complete. When eligible to
participate in the study; patients will visit the CRC 4 times. Two times
wearing the PP and two times wearing the CP. Estimated duration of these visits
is 5.5 hours per visit, totalling 23 hours of time spent in the CRC for the
duration of the entire study. Blood samples will be drawn during the CRC
admissions. Risk to the patient includes haematoma or infection around the
blood collection catheter sites or the insulin catheter / insulin pod insertion
site. This risk is known to be very low with currently available insulin pump
devices. A maximum volume of 310 mL of blood will be drawn during the entire
duration of the study.
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 DM at least 6 months according to the WHO definition
Treated with CSII or MDII for at least 3 months
Body Mass Index (BMI) <35 kg/m²
HbA1c measured during the last three months between 6 and 10%
Using <66 insulin units per day on average.
Exclusion criteria
Patient is pregnant or breastfeeding
Patient is using a medication which significantly impacts glucose metabolism, except if stable for at least 3 months
Patient has a severe medical or psychological condition which, in the opinion of the investigator, prohibits participation in the study.
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 | NL35409.018.11 |