NCT00813280

Brief Summary

The major purpose of this Quality Improvement project is to begin to address the issues surrounding glycemic control in the hospital setting by collecting accurate, reliable and verifiable data on the occurrence of hyperglycemia (BG \>300 mg/dL), and whether or not CIO is used (immediately before and 72 hours after the BG \>300 mg/dl).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2008

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

December 19, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 23, 2008

Completed
Last Updated

November 26, 2015

Status Verified

December 1, 2008

Enrollment Period

3 months

First QC Date

December 19, 2008

Last Update Submit

November 25, 2015

Conditions

Hyperglycemia

Outcome Measures

Primary Outcomes (1)

  • glucose levels

    72 hours

Secondary Outcomes (1)

  • type of insulin treatment

    72 hours

Study Arms (1)

hyperglycemia

hospitalized patients with BG \>300 ml/dL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

hospitalized patients with blood glucose \>300 mg/dL

You may qualify if:

  • Park Nicollet Methodist Hospital patient
  • recorded BG \> 300 mg/dL during the study data collection period
  • admitted to general floor hospital units

You may not qualify if:

  • birth center
  • intensive care units
  • eating disorder unit
  • pediatric patients \< 18 years of age
  • patients receiving insulin infusions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Park Nicollet Methodist Hospital

Minneapolis, Minnesota, 55416, United States

Location

Related Publications (2)

  • van den Berghe G, Wouters P, Weekers F, Verwaest C, Bruyninckx F, Schetz M, Vlasselaers D, Ferdinande P, Lauwers P, Bouillon R. Intensive insulin therapy in critically ill patients. N Engl J Med. 2001 Nov 8;345(19):1359-67. doi: 10.1056/NEJMoa011300.

    PMID: 11794168BACKGROUND

  • Malmberg K, Ryden L, Efendic S, Herlitz J, Nicol P, Waldenstrom A, Wedel H, Welin L. Randomized trial of insulin-glucose infusion followed by subcutaneous insulin treatment in diabetic patients with acute myocardial infarction (DIGAMI study): effects on mortality at 1 year. J Am Coll Cardiol. 1995 Jul;26(1):57-65. doi: 10.1016/0735-1097(95)00126-k.

    PMID: 7797776BACKGROUND

MeSH Terms

Conditions

Hyperglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Lisa Fish, MD

    Park Nicollet Health Services Endocrinology

    PRINCIPAL INVESTIGATOR

  • Robert M Cuddihy, MD

    International Diabetes Center at Park Nicollet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 19, 2008

First Posted

December 23, 2008

Study Start

June 1, 2008

Primary Completion

September 1, 2008

Study Completion

December 1, 2008

Last Updated

November 26, 2015

Record last verified: 2008-12

Locations

US(1)