NCT00309465

Brief Summary

The main objective of this study is to compare three strategies of evening insulin glargine dosing to preoperative glucose values in patients with diabetes undergoing surgery to determine which dosing strategies most often achieves the admission target study values of 100-179 mg/dl.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
402

participants targeted

Target at P75+ for phase_4 diabetes

Timeline
Completed

Started Oct 2005

Longer than P75 for phase_4 diabetes

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 30, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 31, 2006

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
3.2 years until next milestone

Results Posted

Study results publicly available

December 3, 2012

Completed
Last Updated

December 3, 2012

Status Verified

November 1, 2012

Enrollment Period

3 years

First QC Date

March 30, 2006

Results QC Date

October 1, 2012

Last Update Submit

November 1, 2012

Conditions

DiabetesSurgery

Keywords

DiabetesInsulin GlargineSurgery

Outcome Measures

Primary Outcomes (1)

  • Primary: Preoperative Fasting Blood Sugar Upon Arrival at the Hospital Prior to Surgery

    Venous blood glucose values were obtained in the preoperative nursing unit. Blood glucose values were analyzed for achievement of target 100-179 mg/dl range and extended 80-249 mg/dl range. Analyses were by intention to treat.

    Day 1

Study Arms (3)

1

EXPERIMENTAL

Patients in Group 1 will administer 80% of their usual insulin glargine dose.

Drug: Lantus

2

ACTIVE COMPARATOR

Group 2 patients will contact their own diabetes care physician and follow those recommendations for the dose.

Other: Insulin

3

EXPERIMENTAL

Group 3 patients will take 50%, 80%, or 100% of their usual insulin glargine dose. Which of those three percentages will be determined by the midpoint of the patient's usual self-reported fasting blood sugar (FBS) range and whether the patients is also taking a rapid-acting insulin.

Drug: Lantus

Interventions

LantusDRUG

Patients in Group 1 will administer 80% of their usual insulin glargine dose.

Also known as: Lantus, Insulin
1
InsulinOTHER

Group 2 patients will contact their own diabetes care physician and follow those recommendations for the dose

Also known as: As directed by regular physician
2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Scheduled for Surgical Procedure
  • Self Management of Diabetes
  • Currently on Evening Insulin Glargine prescribed by Primary Care Physician
  • Age 18 or over
  • Able to Communicate Clearly over the Phone
  • Pre-screened by Anesthesia Department \> 48 hours prior to Surgery

You may not qualify if:

  • On Glucocorticoid Medication
  • On Insulin Glargine Dual Dosing or Sliding Scale Regimen
  • History of Hypoglycemia Unawareness
  • Pregnancy or Lactating Female
  • On Insulin Glargine for \< 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

William Beaumont Hospital

Troy, Michigan, 48085, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Insulin GlargineInsulin

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsProinsulin

Limitations and Caveats

Limitations include use of point-of-care glucometers, which are less precise than central laboratory testing; estimated 75% power in the insulin glargine only group; and varying fasting lengths, usual glycemic control and surgery starting times.

Results Point of Contact

Title
Tamra Dukatz, CRNA, MSN
Organization
Beaumont Health System
tdukatz@beaumont.edu
248 992-4741 (pager)

Study Officials

  • Tamra Dukatz, MSN, CRNA

    Corewell Health East

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 30, 2006

First Posted

March 31, 2006

Study Start

October 1, 2005

Primary Completion

October 1, 2008

Study Completion

October 1, 2009

Last Updated

December 3, 2012

Results First Posted

December 3, 2012

Record last verified: 2012-11

Locations

US(2)