Clinical trial NCT02241317: Diabetes Mellitus at the University Medical Center of Mannheim
Official title: Effects of Training of Medical Staff on the Outcome of In-Patients With Diabetes Mellitus on Regular Wards
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes Mellitus
Hypoglycaemia
Keywords: Diabetes mellitus
Hypoglycaemia
staff training
Education
blood glucose
Lead sponsor: Universitätsmedizin Mannheim
Sponsor class: OTHER
First posted: 2014-09-16
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In-Patients with Diabetes mellitus

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* Diabetes mellitus

Exclusion Criteria:

* Age \<18 years

Primary outcomes:
measure: Hypoglycaemia
timeFrame: 2013-2015 (two years)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Universitätsmedizin Mannheim
name: Alexander Lammert, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: