Diabetes Mellitus, Type 1NCT07052292
User Experience With DuraTouch® in Patients With Type 1 or Type 2 Diabetes
An observational study of Diabetes Mellitus, Type 1 and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 11 sites in Poland.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
- What is being tested?
- DuraTouch®
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 128 participants
- Where
- 11 sitesPoland
- Study dates
- 1 Jul 2025to 9 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Study population included participants with Type 1 Diabetes Mellitus (T1DM) or Type 2 Diabetes Mellitus (T2DM) who require insulin injection.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Poland11 sites
Poradnia Diabetologiczna. Niepubliczny Zaklad Opieki Zdrowotnej Lege Artis
Bialystok, Podlaskie Voivodeship, 15-404
Diab Serwis POPENDA Spólka Jawna
Chorzów, Silesian Voivodeship, 41-500
NZOZ Gdanska Poradnia Cukrzycowa Sp. z o.o
Gdansk, Pomeranian Voivodeship, 80-858
CenterMed Krakow Sp. z o.o.
Krakow, Lesser Poland Voivodeship, 31-530
"Santa Familia PTG tódz
Lodz, Pomeranian Voivodeship, 90-302
Diabetolog praktyka lekarska - Bartosz Bednarkiewicz
Lubin, Lower Silesian Voivodeship, 59-300
Centrum Medyczne Ekamed sp. z o.o.
Lublin, Lublin Voivodeship, 20-718
Diabetica sp. z o.o.
Nysa, Opole Voivodeship, 48-300
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i Administracji - Klinika Chorob Wewnetrznych, Endokrynologii i Diab
Warsaw, Masovian Voivodeship, 02-507
Ginemedica Sp. z o.o. Sp.k
Wroclaw, Kuyavian-Pomeranian Voivodeship, 50-414
Gabinet Lekarski Internistyczny Iwona Towpik
Zielona Góra, Lubusz Voivodeship, 65-034
About this study
Official title: DuraTouch® - Post-Market Clinical Follow-up (PMCF) Study in a Real-world Setting
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.
- Being tested
- DuraTouch®
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DuraTouch®Device
Participants will subcutaneously inject the insulin using DuraTouch®.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: DuraTouch® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At week 12
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: At week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2025
- Study start1 Jul 2025
- Primary completion9 Jan 2026
- Study completion9 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 2834), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07052292
- Sponsor's protocol ID
- NN1250-8353
- Other IDs
- U1111-1316-4217
- Status last verified
- Apr 2026
- First submitted
- 26 Jun 2025
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DuraTouch® - Post-Market Clinical Follow-up (PMCF) Study in a Real-world Setting
- ClinicalTrials.gov ID
- NCT07052292
- Acronym / sponsor ID
- NN1250-8353
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 9 Jan 2026 (actual)
- Study completion
- 9 Jan 2026 (actual)
- First posted
- 4 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DuraTouch® (Insulin injection) | – | Device: DuraTouch®Participants will subcutaneously inject the insulin prescribed by the doctor using DuraTouch® according to routine clinical practice at the discretion of the treating physician. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Study population included participants with Type 1 Diabetes Mellitus (T1DM) or Type 2 Diabetes Mellitus (T2DM) who require insulin injection.
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DuraTouch®Participants will subcutaneously inject the insulin using DuraTouch®. | Device | DuraTouch® (Insulin injection) |
Primary outcome
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.
3 secondary outcomes
Participant rating the ease of preparing the device for use and ease of injection
Time frame: At week 12
Participant rating the confidence of using the device correctly and confidence in the device delivering the correct full dose
Time frame: At week 12
Participant rating ease to learn how to use the device
Time frame: At week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Transparency (dept. 2834) study director
Novo Nordisk A/S
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 1 and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 11 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant rating the ease of use, convenience and satisfaction with the device (time frame: At week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.