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
NCT number | NCT05377385 |
Other study ID # | 2022/018 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | April 13, 2022 |
Est. completion date | September 1, 2022 |
Verified date | September 2022 |
Source | Jessa Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Belgium | Jessa Hospital | Hasselt | Limburg |
Lead Sponsor | Collaborator |
---|---|
Jessa Hospital |
Belgium,
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 |
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