DiabetesNCT01516242
Evaluation of Safety and Parameters of Application Technique
An observational study of Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 1 site in Slovakia.
Trial summary
This study is conducted in Europe. The aim of the study is to monitor patients changing therapy from syringe to insulin delivery system as prescribed by the treating physician in Slovakia. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
- What is being tested?
- No treatment given
- Type of treatment
- Injection or infusion
- How many people
- 4,819 participants
- Where
- 1 siteSlovakia
- Study dates
- Oct 2006to Dec 2007
- 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: Patients with type 1 diabetes or type 2 diabetes mellitus treated with insulin having changed administration of inulin from syringe to a Novo Nordisk insulin delivery system
Who may be able to join
- Diabetes mellitus (type 1 or type 2)
- Treated with insulin
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Monitoring of Expected Parameters of the Application Technique and Safety of the Therapy
This study is conducted in Europe. The aim of the study is to monitor patients changing therapy from syringe to insulin delivery system as prescribed by the treating physician in Slovakia.
- Being tested
- No treatment given
- Medical subject headings
- Diabetes Mellitus, 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.
No treatment givenOther
Collection of data about patients with type 1 diabetes or type 2 diabetes treated with insulin changing their insulin administration from syringe to a insulin delivery system based on completion of questionaire
| Study group | Role | What they receive |
|---|---|---|
| NovoPen® 4 | Not described Receives: Other: No treatment given |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of insulin applications (punctures)
Reasons leading to change of the therapy
Patient satisfaction with NovoPen® 4 insulin delivery system
Secondary outcomes (2)
Adverse reactions
Hypoglycaemia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2012 (estimated)
- Study startOct 2006
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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
- 4,819 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Registry (GCR, 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01516242
- Sponsor's protocol ID
- MS236-1926
- Status last verified
- Nov 2016
- First submitted
- 19 Jan 2012
- Last updated
- 7 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring of Expected Parameters of the Application Technique and Safety of the Therapy
- ClinicalTrials.gov ID
- NCT01516242
- Acronym / sponsor ID
- MS236-1926
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,819 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 24 Jan 2012 (estimated)
- 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 is conducted in Europe. The aim of the study is to monitor patients changing therapy from syringe to insulin delivery system as prescribed by the treating physician in Slovakia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NovoPen® 4 | – | Other: No treatment given |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with type 1 diabetes or type 2 diabetes mellitus treated with insulin having changed administration of inulin from syringe to a Novo Nordisk insulin delivery system
Key inclusion criteria (2 listed)
- Diabetes mellitus (type 1 or type 2)
- Treated with insulin
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| No treatment givenCollection of data about patients with type 1 diabetes or type 2 diabetes treated with insulin changing their insulin administration from syringe to a insulin delivery system based on completion of questionaire | Other | NovoPen® 4 |
Primary outcome
Number of insulin applications (punctures)
Reasons leading to change of the therapy
Patient satisfaction with NovoPen® 4 insulin delivery system
2 secondary outcomes
Adverse reactions
Hypoglycaemia
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 7 Nov 2016.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
Related trials for Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
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.
Global Clinical Registry (GCR, 1452) study director
Novo Nordisk A/S
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 1 site in Slovakia.
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 0 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 7 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovakia. 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?
Number of insulin applications (punctures). The study lists 3 primary outcomes in all. 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 7 Nov 2016.