NCT05377385

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 36 (actual)
• Sponsor: Jessa Hospital · Academic / Other
• Sex: All
• Age: 6 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes Mellitus, Type 1
• Children
• Metabolic Control
• Patient Satisfaction

Interventions

Type	Name	Description
BEHAVIORAL	Questionnaire	Questionnaire about usability of the Omnipod DASH insulin administration system

Timeline

• Start date: 2022-04-13
• Primary completion: 2022-09-01
• Completion: 2022-09-01
• First posted: 2022-05-17
• Last updated: 2022-09-23

Locations

1 site across 1 country: Belgium