Evaluation of an Algorithm for Intensive s.c. Insulin Therapy in Emergency Room Patients With Hyperglycaemia

NCT00353431 | Completed Results

• 2 other identifiers: EKBB13/06ISRCTN55224894
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to test the safety and efficacy of a new algorithm for intensive s.c. insulin injection in medical emergency patients with hyperglycaemia (plasma glucose concentration ≥ 8 mmol/l)

Conditions

Hyperglycemias

Keywords

Hyperglycaemia; algorithm; emergency; s.c. insulin therapy; Emergency patient

Outcome Measures

Primary Outcomes (1)

• Time in the Glycaemic Target Range (5.5-7.0 mmol/l) During the Period of Observation of 48 Hours

  Hours in which the plasma glucose was between 5.5 and 7.0 mmol/l (expected to be longer in the intensive insulin group)

  48 h

Secondary Outcomes (4)

• Time to Reach the Target Range

  24 h

• Frequency of Hypoglycemia

  during observation of 48 hours

• Frequency of Severe Hypoglycaemia

  during observation of 48 hours

• Frequency of Hypokalaemia

  during observation of 48 hours

Study Arms (2)

1

ACTIVE COMPARATOR

Conventional insulin group: In the conventional insulin group only the meal-glucose adapted sliding scale at beginning is pre-determined. All adaptations of the insulin sliding scale remain upon the discretion of the treating physician.

Drug: Novorapid ®, Novo Nordisk, Denmark

2

EXPERIMENTAL

Intensive insulin therapy algorithm: The algorithm in the intensive insulin group contains four insulin resistance factors, depending on baseline features of the patients and on the changes of plasma glucose levels after insulin administration. Every two to four hours the plasma glucose level is measured and Insulin aspart (Novorapid®) is injected s.c. according to the scheme. If the patient is eating, the dose of Insulin aspart (NovoRapid®)is increased according to the amount of carbohydrate intake.

Drug: Novorapid ®, Novo Nordisk, Denmark

Interventions

Novorapid ®, Novo Nordisk, Denmark DRUG

Comparison of a sliding scale with an intensive s.c. scale

Also known as: insulin aspart,, Novolog

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• all patients with hyperglycaemia (≥ 8.0 mmol/l) admitted to the medical emergency room.
• patients with presumed hospitalisation in ER or medical ward of more than 48 h duration.

You may not qualify if:

• patients in shock (defined as hypotension or shock index \> 1 with oliguria, changed mental status and metabolic acidosis)
• patients with a terminal illness on palliative care
• patients with type 1 diabetes
• patients with insulin pump therapy
• patients with need for hospitalisation in the intensive or coronary care unit.
• patients with presumed hospitalisation shorter than 48 hours
• no informed consent

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

Division of Endocrinology, Diabetes & Clinical Nutrition, Dept of Internal Medicine,

Basel, Canton of Basel-City, 4031, Switzerland

Location

MeSH Terms

Conditions

Hyperglycemia; Emergencies

Interventions

Insulin Aspart

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Limitations and Caveats

Small sample size

Results Point of Contact

• Title: Robert Thomann, MD
• Organization: Intern Medicine Solothurn, Switzerland

endodiab.bss@bluewin.ch

+41326274501

Study Officials

• Ulrich Keller, MD, Prof

  Division of Endocrinology, Diabetes & Clinical Nutrition, Dept of Internal Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2006
• First Posted: July 18, 2006
• Study Start: December 1, 2006
• Primary Completion: April 1, 2010
• Study Completion: October 1, 2010
• Last Updated: May 18, 2012
• Results First Posted: May 8, 2012

Record last verified: 2012-05

Locations

CH (1)