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Completed

NCT Number: NCT05377385

Evaluation of the Omnipod DASH 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.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Behavior Children Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Health Behavior Immune System Diseases Metabolic Control Metabolic Diseases Nutritional and Metabolic Diseases Patient Satisfaction Treatment Adherence and Compliance

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Jessa Hospital

Hasselt, Limburg, B3500, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaire

Behavioral

Questionnaire about usability of the Omnipod DASH insulin administration system

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

Jessa Hospital

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 17, 2022
Registry last updated
Sep 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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