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OpenTrials
Completed

NCT Number: NCT07052292

User Experience With DuraTouch® in Patients With Type 1 or Type 2 Diabetes

This study looks at overall impact of the use of DuraTouch® in terms of ease, convenience to use and satisfaction in participants with either type 1 or type 2 diabetes.The study will last for about 12 weeks.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Ginemedica Sp. z o.o. Sp.k, Wroclaw, Kuyavian-Pomeranian Voivodeship, Poland

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • The decision to initiate treatment with DuraTouch® has been made by the participant/legally acceptable representative (LAR) and the treating physician before and independently from the decision to include the participant in this study.
  • All needed signed consent(s) are obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).

Exclusion criteria

  • Previous participation in this study. Participation is defined as having given informed consent in this study.
  • Mental incapacity (when no caregiver and LAR are assigned to the patient), unwillingness or language barriers precluding adequate understanding or cooperation.

Treatment and study plan

DuraTouch®

Device

Participants will subcutaneously inject the insulin using DuraTouch®.

Primary outcomes

  1. Participant rating the ease of use, convenience and satisfaction with the device

    Time frame: At week 12

    Rating score on a 5-point Likert-type response scale. 1=Not at all easy/convenient/satisfied, 5=Extremely easy/convenient/satisfied.

Secondary outcomes

  1. Participant rating the ease of preparing the device for use and ease of injection

    Time frame: At week 12

    Rating score on a 5-point Likert-type response scale. 1=Not at all easy, 5=Extremely easy.

  2. Participant rating the confidence of using the device correctly and confidence in the device delivering the correct full dose

    Time frame: At week 12

    Rating score on a 5-point Likert-type response scale. 1=Not at all confident, 5=Extremely confident.

  3. Participant rating ease to learn how to use the device

    Time frame: At week 12

    Rating score on a 5-point Likert-type response scale. 1=Very difficult, 5=Very Easy.

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

DuraTouch® - Post-Market Clinical Follow-up (PMCF) Study in a Real-world Setting

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 4, 2025
Registry last updated
Apr 9, 2026

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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