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

NCT07052292 | Completed FDA Device

• 2 other identifiers: NN1250-8353U1111-1316-4217
• Study Type: observational
• Target: 128
• Locations: 1 country
• Sites: 11

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.

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

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

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

  At week 12

Secondary Outcomes (3)

• Participant rating the ease of preparing the device for use and ease of injection

  At week 12

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

  At week 12

• Participant rating ease to learn how to use the device

  At week 12

Study Arms (1)

DuraTouch® (Insulin injection)

Participants will subcutaneously inject the insulin prescribed by the doctor using DuraTouch® according to routine clinical practice at the discretion of the treating physician.

Device: DuraTouch®

Interventions

DuraTouch® DEVICE

Participants will subcutaneously inject the insulin using DuraTouch®.

DuraTouch® (Insulin injection)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study population included participants with Type 1 Diabetes Mellitus (T1DM) or Type 2 Diabetes Mellitus (T2DM) who require insulin injection.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (11)

Ginemedica Sp. z o.o. Sp.k

Wroclaw, Kuyavian-Pomeranian Voivodeship, 50-414, Poland

Location

CenterMed Krakow Sp. z o.o.

Krakow, Lesser Poland Voivodeship, 31-530, Poland

Location

Diabetolog praktyka lekarska - Bartosz Bednarkiewicz

Lubin, Lower Silesian Voivodeship, 59-300, Poland

Location

Centrum Medyczne Ekamed sp. z o.o.

Lublin, Lublin Voivodeship, 20-718, Poland

Location

Gabinet Lekarski Internistyczny Iwona Towpik

Zielona Góra, Lubusz Voivodeship, 65-034, Poland

Location

Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i Administracji - Klinika Chorob Wewnetrznych, Endokrynologii i Diab

Warsaw, Masovian Voivodeship, 02-507, Poland

Location

Diabetica sp. z o.o.

Nysa, Opole Voivodeship, 48-300, Poland

Location

Poradnia Diabetologiczna. Niepubliczny Zaklad Opieki Zdrowotnej Lege Artis

Bialystok, Podlaskie Voivodeship, 15-404, Poland

Location

NZOZ Gdanska Poradnia Cukrzycowa Sp. z o.o

Gdansk, Pomeranian Voivodeship, 80-858, Poland

Location

"Santa Familia PTG tódz

Lodz, Pomeranian Voivodeship, 90-302, Poland

Location

Diab Serwis POPENDA Spólka Jawna

Chorzów, Silesian Voivodeship, 41-500, Poland

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2025
• First Posted: July 4, 2025
• Study Start: July 1, 2025
• Primary Completion: January 9, 2026
• Study Completion: January 9, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

PL (11)