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

NCT05377385 | Completed

• 1 other identifier: 2022/018
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Type 1 diabetes mellitus; child; insulin administration; Omnipod DASH; usability; metabolic control

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Metabolic control of type 1 diabetes mellitus

  Before and during the first 6 months of wearing the Omnipod Dash insulin administration system

Study Arms (1)

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

Interventions

Questionnaire BEHAVIORAL

Questionnaire about usability of the Omnipod DASH insulin administration system

Study group

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

• Children and adolescents with type 1 diabetes mellitus
• Patients who started in 2021 with the Omnipod DASH insulin administration system in the Jessa Hospital

You may not qualify if:

• Children and adolescents without type 1 diabetes mellitus
• Children and adolescents with type 1 diabetes treated with insulin pens or other insulin pumps

Sponsors & Collaborators

• Jessa Hospital: lead

Study Sites (1)

Jessa Hospital

Hasselt, Limburg, B3500, Belgium

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Patient Satisfaction

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Guy Massa

  Jessa Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2022
• First Posted: May 17, 2022
• Study Start: April 13, 2022
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: September 23, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)