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

Diabetes Mellitus, Type 1 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05377385
• Other study ID #: 2022/018
• Status: Completed
• Start date: April 13, 2022
• Est. completion date: September 1, 2022

Study information

• Verified date: September 2022
• Source: Jessa Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: September 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Questionnaire
Questionnaire about usability of the Omnipod DASH insulin administration system

Locations

Country	Name	City	State
Belgium	Jessa Hospital	Hasselt	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Jessa Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Usability of and problems encountered with the Omnipod Dash insulin administration system	Usability of and problems encountered with the Omnipod Dash insulin administration system is evaluated by 2 home made questionnaire evaluated by a 5 point Likert scale. The first questionnaire includes 3 questions about the application of the pod (e.g. it is easy to place the pod), 7 questions about the wearing of the pod (e.g. the pod doesn't hinder me during sleeping) and 11 questions comparing insulin administration with insulin pens (e.g. insulin administration with the pod is more discrete). The second questionnaire includes 9 questions about possible problems with the Omnipod DASH insulin administration system (e.g. I developped an allergic skin reaction).	Through study completion, an average of 6 months
Secondary	Metabolic control of type 1 diabetes mellitus	Metabolic control of the type 1 diabetes mellitus measured by HbA1c levels and results from continuous glucose measurement data (e.g. time in range, time below range, time above range).	Before and during the first 6 months of wearing the Omnipod Dash insulin administration system