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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07052292

Enrollment

128

Registered

2025-07-04

Start date

2025-07-01

Completion date

2026-01-09

Last updated

2026-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

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.

Interventions

DEVICEDuraTouch®

Participants will subcutaneously inject the insulin using DuraTouch®.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Poland

Contacts

STUDY_DIRECTORClinical Transparency (dept. 2834)

Novo Nordisk A/S

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 10, 2026