Diabetes MellitusDmUMMNCT02241317
Diabetes Mellitus at the University Medical Center of Mannheim
An observational study of Diabetes Mellitus and Hypoglycaemia, run by Universitätsmedizin Mannheim.
Trial summary
Development of a training concept for health care professionals (nursing and medical staff), according to the current guidelines on treatment of in-patients with Diabetes. Primary endpoint is the change in hypoglycaemia rates comparing data before and after the training. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Hypoglycaemia
- How many people
- 5,000 participants
- Where
- No sites listed yet
- Study dates
- Jun 2014to Apr 2015
- How long will I take part?
- 1 Year
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: In-Patients with Diabetes mellitus
Who may be able to join
- Diabetes mellitus
Who cannot join
- Age <18 years
About this study
Official title: Effects of Training of Medical Staff on the Outcome of In-Patients With Diabetes Mellitus on Regular Wards
Development of a training concept for health care professionals (nursing and medical staff), according to the current guidelines on treatment of in-patients with Diabetes. Primary endpoint is the change in hypoglycaemia rates comparing data before and after the training. Hereby we can derive the effects of staff training on the quality of health care in this patient population.
Read the detailed description
The prevalence of Diabetes in in-patients is about 32% and therefore exceeds significantly the prevalence in general population.
In most cases Diabetes is only a secondary diagnosis the medical staff has to deal with daily. The diagnosis which leads to hospital admission and the often multiple comorbidities complicate the metabolic control. Blood sugar imbalances present an additional risk for these patients and increase in-hospital mortality, length of hospital stay and general complications as nosocomial infections.
To improve hospital care for diabetics the Endocrine Society and the American College of Physicians published new guidelines on blood glucose management for non-ICU wards. Primarily they contain recommendations for blood glucose target range and standards to improve inpatient hospital care like standard operating procedures for blood glucose monitoring as well as hyper- and hypoglycaemic disturbances through to discharge management.
We developed a training concept for health care professionals (nursing and medical staff), according to the current guidelines on treatment of in-patients with Diabetes. Primary endpoint is the change in hypoglycaemia rates comparing data before and after the training. Hereby we can derive the effects of staff training on the quality of health care in this patient population.
So far there was only one comparable study published which showed a significant improvement of treatment quality by reducing hypoglycaemia rates considerably . The results of this study cannot be transferred due to substantial structural differences. More over there are no national diabetes management guidelines for inpatient treatment in Germany.
The following data will be collected:
- Anthropometric data (Age, Sex, Bodyweight, Height)
- Diagnosis
- POCT blood glucose values
- Other laboratory values
- Length of hospital stay
This study conforms to the requirements of the Declaration of Helsinki, Revision of 1996.
- Conditions
- Diabetes Mellitus, Hypoglycaemia
- Keywords
- Diabetes mellitus, Hypoglycaemia, staff training, Education, blood glucose
- Medical subject headings
- Diabetes Mellitus, Hypoglycemia
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypoglycaemia
Measured: 2013-2015 (two years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2014 (estimated)
- Study startJun 2014
- Primary completionMar 2015 (estimated)
- Study completionApr 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- 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
- 5,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Universitätsmedizin Mannheim
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexander Lammert, Universitätsmedizin Mannheim
- Investigators
- Alexander Lammert, Dr. med., Principal investigator, Universitätsmedizin Mannheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02241317
- Sponsor's protocol ID
- 2014-831R-MA
- Acronym
- DmUMM
- Status last verified
- Sep 2014
- First submitted
- 11 Sep 2014
- Last updated
- 16 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Training of Medical Staff on the Outcome of In-Patients With Diabetes Mellitus on Regular Wards
- ClinicalTrials.gov ID
- NCT02241317
- Acronym / sponsor ID
- DmUMM / 2014-831R-MA
- Conditions
- Diabetes Mellitus, Hypoglycaemia
- Keywords
- Diabetes mellitus, Hypoglycaemia, staff training, Education, blood glucose
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Universitätsmedizin MannheimUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Mar 2015 (estimated)
- Study completion
- Apr 2015 (estimated)
- First posted
- 16 Sep 2014 (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.
Development of a training concept for health care professionals (nursing and medical staff), according to the current guidelines on treatment of in-patients with Diabetes. Primary endpoint is the change in hypoglycaemia rates comparing data before and after the training. Hereby we can derive the effects of staff training on the quality of health care in this patient population.
Detailed description
The prevalence of Diabetes in in-patients is about 32% and therefore exceeds significantly the prevalence in general population.
In most cases Diabetes is only a secondary diagnosis the medical staff has to deal with daily. The diagnosis which leads to hospital admission and the often multiple comorbidities complicate the metabolic control. Blood sugar imbalances present an additional risk for these patients and increase in-hospital mortality, length of hospital stay and general complications as nosocomial infections.
To improve hospital care for diabetics the Endocrine Society and the American College of Physicians published new guidelines on blood glucose management for non-ICU wards. Primarily they contain recommendations for blood glucose target range and standards to improve inpatient hospital care like standard operating procedures for blood glucose monitoring as well as hyper- and hypoglycaemic disturbances through to discharge management.
We developed a training concept for health care professionals (nursing and medical staff), according to the current guidelines on treatment of in-patients with Diabetes. Primary endpoint is the change in hypoglycaemia rates comparing data before and after the training. Hereby we can derive the effects of staff training on the quality of health care in this patient population.
So far there was only one comparable study published which showed a significant improvement of treatment quality by reducing hypoglycaemia rates considerably . The results of this study cannot be transferred due to substantial structural differences. More over there are no national diabetes management guidelines for inpatient treatment in Germany.
The following data will be collected:
- Anthropometric data (Age, Sex, Bodyweight, Height)
- Diagnosis
- POCT blood glucose values
- Other laboratory values
- Length of hospital stay
This study conforms to the requirements of the Declaration of Helsinki, Revision of 1996.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In-Patients with Diabetes mellitus
Key inclusion criteria (1 listed)
- Diabetes mellitus
Key exclusion criteria (1 listed)
- Age <18 years
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
Hypoglycaemia
Time frame: 2013-2015 (two years)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2014.
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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.
Alexander Lammert, Dr. med. principal investigator
Universitätsmedizin Mannheim
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus and Hypoglycaemia, run by Universitätsmedizin Mannheim.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 16 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Hypoglycaemia (time frame: 2013-2015 (two years)). 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 16 Sep 2014.