Evaluation of the Omnipod DASH in Children and Adolescents With Type 1 Diabetes Mellitus

Jessa Hospital

Status: Completed

Conditions: Diabetes Mellitus, Type 1; Patient Satisfaction; Children; Metabolic Control

Treatments: Behavioral: Questionnaire

Study type: Observational

Funder types: Other

Identifiers

NCT05377385

2022/018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 6 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

36 participants in 1 patient group

Study group

Description:

Children and adolescents with type 1 diabetes mellitus who started in 2021 in the Jessa Hospital with the Omnipod DASH insulin administration device.

Treatment:

Behavioral: Questionnaire