Diabetes Mellitus at the University Medical Center of Mannheim

NCT ID: NCT02241317

Last Updated: 2014-09-16

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 5000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2015-04-30

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.

Conditions

Diabetes Mellitus; Hypoglycaemia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Diabetes mellitus

Exclusion Criteria

• Age <18 years

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitätsmedizin Mannheim

OTHER

Sponsor Role: lead

Responsible Party

Alexander Lammert

Dr. med. Alexander Lammert

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alexander Lammert, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Universitätsmedizin Mannheim

Other Identifiers

2014-831R-MA

Identifier Type: -

Identifier Source: org_study_id