Clinical trial NCT05377385: Evaluation of the Omnipod DASH in Children and Adolescents With Type 1 Diabetes Mellitus
Official title: Evaluation of the Usability and Effect on the Metabolic Control of the Omnipod DASH Insulin Administration System in Children and Adolescents With Type 1 Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 1
Children
Metabolic Control
Patient Satisfaction
Keywords: Type 1 diabetes mellitus
child
insulin administration
Omnipod DASH
usability
metabolic control
Lead sponsor: Jessa Hospital
Sponsor class: OTHER
First posted: 2022-05-17
Enrollment: 36
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children and adolescents with type 1 diabetes mellitus who started in 2021 in the Jessa Hospital with the Omnipod DASH insulin administration system

Brief summary: In this study the usability of the Omnipod DASH insulin administration system is evaluated prospectively by two questionnaires. The effect on the metabolic control is evaluated retrospectively by analysis of data from the medical records of the patients.

Detailed description: In the study the usability of the Omnipod DASH (= insulin patch pump) is evaluated prospectively by two questionnaires. The first questionnaire concerns practical items on the application of the pump (e.g. Is it easy to fill to pod?), the wearing of the pump (e.g. Is it comfortable to wear the pump?) and the comparison with insulin administration with insulin pens or other insulin pumps (e.g. is it less painful to administrate insulin by the Omnipod DASH pump). The second questionnaire asks for possible problems that the patients experienced during the wearing of the pump (e.g. did you experience an allergic skin reaction). The questions are formulated to be answered by a 5-point likert scale.

The metabolic control is studied retrospectively from data extracted from the medical records, i.e. the results of the determination of HbA1c and the results from continuous glucose monitoring (CGM) at the start, and after 2, 4 and 6 months of the wearing of the Omnipod DASH insulin pump.

Eligibility criteria: Inclusion Criteria:

* Children and adolescents with type 1 diabetes mellitus
* Patients who started in 2021 with the Omnipod DASH insulin administration system in the Jessa Hospital

Exclusion Criteria:

* Children and adolescents without type 1 diabetes mellitus
* Children and adolescents with type 1 diabetes treated with insulin pens or other insulin pumps

Primary outcomes:
measure: Usability of and problems encountered with the Omnipod Dash insulin administration system
timeFrame: Through study completion, an average of 6 months
Secondary outcomes:
measure: Metabolic control of type 1 diabetes mellitus
timeFrame: Before and during the first 6 months of wearing the Omnipod Dash insulin administration system
Other outcomes:
Locations:
city: Hasselt
country: Belgium
facility: Jessa Hospital
state: Limburg
Study officials:
affiliation: Jessa Hospital
name: Guy Massa
role: PRINCIPAL_INVESTIGATOR
References: