Diabetes Mellitus at the University Medical Center of Mannheim

Diabetes Mellitus Clinical Trial

— DmUMM  

Official title:

Effects of Training of Medical Staff on the Outcome of In-Patients With Diabetes Mellitus on Regular Wards

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02241317
• Other study ID #: 2014-831R-MA
• Status: Active, not recruiting
• Phase: N/A
• First received: September 11, 2014
• Last updated: September 15, 2014
• Start date: June 2014
• Est. completion date: April 2015

Study information

• Verified date: September 2014
• Source: Universitätsmedizin Mannheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Regierungspräsidium Karlsruhe
• Study type: Observational [Patient Registry]

Clinical 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. Hereby we can derive the effects of staff training on the quality of health care in this patient population.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 5000
• Est. completion date: April 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diabetes mellitus

Exclusion Criteria:

• Age <18 years

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus
• Hypoglycaemia
• Hypoglycemia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsmedizin Mannheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hypoglycaemia		2013-2015 (two years)	No