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

Novo Nordisk A/S128 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

128

Conditions

Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2

Interventions

DuraTouch®DEVICE

Participants will subcutaneously inject the insulin using DuraTouch®.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (11)

Ginemedica Sp. z o.o. Sp.k

Wroclaw, Kuyavian-Pomeranian Voivodeship, Poland

CenterMed Krakow Sp. z o.o.

Krakow, Lesser Poland Voivodeship, Poland

Diabetolog praktyka lekarska - Bartosz Bednarkiewicz

Lubin, Lower Silesian Voivodeship, Poland

Outcomes

Primary Outcomes

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.

Time frame: At week 12

Secondary Outcomes

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

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

Time frame: At week 12

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

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

Time frame: At week 12

Participant rating ease to learn how to use the device

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

Time frame: At week 12

Data from ClinicalTrials.gov

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