To perform a patient satisfaction study on the Equil patch pump in T1DM patients that currently already use CSII in combination with CGM or Flash glucose monitoring.
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Patient satisfaction compared to current CSII system
Secondary outcome
Number of perceived dysfunctions, unexpected hypo- and hyperglycaemia,
ketoacidosis
Background summary
Maintaining glycemic values at levels of nondiabetic range is efficient in
preventing long-term complications of type 1 diabetes mellitus (T1D) (1,2,3).
However, achieving good glucose control is challenging and still difficult to
achieve for more than half of the patients. Today, thanks to the tools offered
by technologies, we can aspire a more sustainable management of diabetes on a
daily basis. In clinical practice, treatment of T1D patients with continuous
subcutaneous insulin infusion by pumps (CSII) in combination with continuous
glucose monitoring (CGM) can lead to improved glycemic control and reduction of
diabetes complications thereby improving quality of life (4, 5). One drawback
of the current CSII pumps is their bulky size, need for tubes thereby limiting
comfort and quality of life on a day-to-day basis.
Patch pumps are novel insulin delivery systems that have emerged on the market
and characterized by smaller size and absence of tubes. Such advantages meet
many patient*s preference achieving clinical improvements through greater
treatment adherence and greater engagement (6,7, 8). From a technical
perspective, they can offer all insulin delivery functionalities as compared
with conventional insulin pump delivery systems.
Some new Patch pump systems include non-disposable components with reduced
costs and environmental impact. Therefore, these systems could be effective and
financially sustainable in larger cohorts of patients. The Equil patch pump has
been extensively tested and has certificates from EN ISO and the European
Committee (zie bijlagen). It is already used in several countries (Italy, Tsech
Republic and Greece, but not yet available in the Netherlands.
Study objective
To perform a patient satisfaction study on the Equil patch pump in T1DM
patients that currently already use CSII in combination with CGM or Flash
glucose monitoring.
Study design
Observational
Study burden and risks
Burden:
At start and at the end of the study the patient is asked to fill in a
questionnaire (about 15min)
There is one telephone call after one week (about 15min)
The patient has to fill in a diary every day (about 5 min per day)
Risks:
If the patient has technical problems with the pump, glucose values might
fluctuate more then normal
Macroweg 10
Venray 5804 CL
NL
Macroweg 10
Venray 5804 CL
NL
Listed location countries
Age
Inclusion criteria
* Male and female patients
* T1D patients <=>18 years
* Using CSII for 12 months or longer and needing a new pump within 6 months
* Using CGM or FGM
* Written informed consent obtained from the patient
Exclusion criteria
* Pregnancy or pregnancy wish
* Patients unable to understand spoken and written Dutch language
* Patients on (hybrid) closed loop systems, i.e. Medtronic 670G pump
* Patients on Medtronic 640G CSII pump that also use CGM-based *stop before low*
* Patients with unstable glucose regulation, for example frequent hypo- or
hyperglycaemia
* Not able to perform the study according to the treating physician
* Severe comorbidity and/or psychiatric disease
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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In other registers
| Register | ID |
|---|---|
| CCMO | NL74682.058.20 |