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

Not yet recruiting

• Conditions: Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

• Registration Number: NCT07052292
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-26
• Study First Submitted QC: 2025-06-26
• Last Update Submitted: 2025-06-26
• Study Start: 2025-06-27
• Study First Posted: 2025-07-04
• Last Update Posted: 2025-07-04
• Primary Completion: 2026-01-02
• Study Completion: 2026-01-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 125

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Participant rating the ease of use, convenience and satisfaction with the device	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 Outcome Measures

Name	Time	Method
Participant rating the ease of preparing the device for use and ease of injection	At week 12	Rating score on a 5-point Likert-type response scale. 1=Not at all easy, 5=Extremely easy.
Participant rating the confidence of using the device correctly and confidence in the device delivering the correct full dose	At week 12	Rating score on a 5-point Likert-type response scale. 1=Not at all confident, 5=Extremely confident.
Participant rating ease to learn how to use the device	At week 12	Rating score on a 5-point Likert-type response scale. 1=Very difficult, 5=Very Easy.