Diabetes MellitusNCT02053077
Risk Identification of the GlucoTab System in Routine Use
An observational study of Diabetes Mellitus, run by Medical University of Graz at 1 site in Austria.
Trial summary
Identification of risks of the GlucoTab system in routine use. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus
- How many people
- 150 participants
- Where
- 1 siteAustria
- Study dates
- Feb 2014to 26 Jun 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: non-critically ill patients with type 2 diabetes at general wards
Who may be able to join
- informed consent obtained after being advised of the nature of the study
- type 2 diabetes or new-onset hyperglycaemia which require s.c. insulin therapy during hospital stay
- diabetes therapy supported by GlucoTab system
Who cannot join
- type 1 diabetes mellitus
- intravenous insulin therapy
- hyperglycaemic episodes (ketoacidosis, hyperosmolar state) if they require intravenous insulin therapy
- gestational diabetes or pregnancy
- known or suspected allergy to certain insulin types, named in the user manual
- total parenteral nutrition (TPN)
- any mental condition rendering the patient incapable of giving his consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Identify Risks in Routine Use of the GlucoTab System for Glycaemic Management in Non-critically Ill Patients With Type 2 Diabetes at General Wards
Identification of risks of the GlucoTab system in routine use.
Read the detailed description
A study to identify risks in routine use of the GlucoTab system for glycaemic management in non-critically ill patients with type 2 diabetes at general wards.
- Conditions
- Diabetes Mellitus
- Medical subject headings
- Diabetes Mellitus
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy: Blood Glucose During Hospital Stay, an Expected Average of 1 Week
efficacy: mean daily blood glucose during hospital stay, an expected average of 1 week
Measured: participants will be followed for the duration of hospital stay, an expected average of 1 week
Secondary outcomes (2)
Efficacy: Blood Glucose During Hospital Stay
Efficacy: mean pre-breakfast blood glucose during hospital stay
Measured: participants will be followed for the duration of hospital stay, an expected average of 1 week
Usability: Coverage of the GlucoTab
Usability: coverage of the GlucoTab treatment during hospital stay
Measured: Participants will be followed for the duration of hospital stay, an expected average of 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionJun 2016
- Study completion26 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pieber Thomas, MD, Medical University of Graz
- Investigators
- Thomas R. Pieber, Univ.Prof.Dr, Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02053077
- Sponsor's protocol ID
- ClinDiab-05
- Status last verified
- May 2023
- First submitted
- 29 Jan 2014
- Last updated
- 12 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Identify Risks in Routine Use of the GlucoTab System for Glycaemic Management in Non-critically Ill Patients With Type 2 Diabetes at General Wards
- ClinicalTrials.gov ID
- NCT02053077
- Acronym / sponsor ID
- ClinDiab-05
- Conditions
- Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- 26 Jun 2016 (actual)
- First posted
- 3 Feb 2014 (estimated)
- Results
- Posted 8 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Identification of risks of the GlucoTab system in routine use.
Detailed description
A study to identify risks in routine use of the GlucoTab system for glycaemic management in non-critically ill patients with type 2 diabetes at general wards.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- non-critically ill patients with type 2 diabetes at general wards
Key inclusion criteria (3 listed)
- informed consent obtained after being advised of the nature of the study
- type 2 diabetes or new-onset hyperglycaemia which require s.c. insulin therapy during hospital stay
- diabetes therapy supported by GlucoTab system
Key exclusion criteria (7 listed)
- type 1 diabetes mellitus
- intravenous insulin therapy
- hyperglycaemic episodes (ketoacidosis, hyperosmolar state) if they require intravenous insulin therapy
- gestational diabetes or pregnancy
- known or suspected allergy to certain insulin types, named in the user manual
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Efficacy: Blood Glucose During Hospital Stay, an Expected Average of 1 Week
Time frame: participants will be followed for the duration of hospital stay, an expected average of 1 week
efficacy: mean daily blood glucose during hospital stay, an expected average of 1 week
2 secondary outcomes
Efficacy: Blood Glucose During Hospital Stay
Time frame: participants will be followed for the duration of hospital stay, an expected average of 1 week
Usability: Coverage of the GlucoTab
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Thomas R. Pieber, Univ.Prof.Dr principal investigator
Medical University of Graz
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 Mellitus, run by Medical University of Graz at 1 site in Austria.
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 3 inclusion and 7 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 12 May 2023. 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 Austria. 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?
Yes. Results are posted in the registry (first posted 8 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Efficacy: Blood Glucose During Hospital Stay, an Expected Average of 1 Week (time frame: participants will be followed for the duration of hospital stay, an expected average of 1 week). 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 12 May 2023.