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

September 22, 2022 updated by: Jessa Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

36

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Limburg
      • Hasselt, Limburg, Belgium, B3500
        • Jessa Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Study group
Children and adolescents with type 1 diabetes mellitus who started in 2021 in the Jessa Hospital with the Omnipod DASH insulin administration device.
Behavioral: Questionnaire
Questionnaire about usability of the Omnipod DASH insulin administration system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Usability of and problems encountered with the Omnipod Dash insulin administration system
Time Frame: Through study completion, an average of 6 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Metabolic control of type 1 diabetes mellitus
Time Frame: Before and during the first 6 months of wearing the Omnipod Dash insulin administration system
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jessa Hospital

Investigators

  • Principal Investigator: Guy Massa, Jessa Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 13, 2022

Primary Completion (Actual)

September 1, 2022

Study Completion (Actual)

September 1, 2022

Study Registration Dates

First Submitted

May 2, 2022

First Submitted That Met QC Criteria

May 11, 2022

First Posted (Actual)

May 17, 2022

Study Record Updates

Last Update Posted (Actual)

September 23, 2022

Last Update Submitted That Met QC Criteria

September 22, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022/018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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