NCT02868606

Brief Summary

Many hospitals have begun giving insulin to nearly all patients with diabetes while they are in the hospital even if a patient does not use insulin at home. Controlling blood sugar with insulin when a patient is hospitalized is believed to reduce the risk of complications and death, but research has not demonstrated these benefits except in patients who are critically ill. The purpose of this study, therefore, is to evaluate whether such insulin therapy actually does reduce in-hospital complications, deaths, need for intensive care, or length of stay in the hospital.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40,391

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2015

Typical duration 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

July 1, 2015

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 29, 2016

Completed
18 days until next milestone

First Posted

Study publicly available on registry

August 16, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2017

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
Last Updated

June 4, 2019

Status Verified

June 1, 2019

Enrollment Period

2.1 years

First QC Date

July 29, 2016

Last Update Submit

June 3, 2019

Conditions

Diabetes Mellitus, Type 2Hyperglycemia

Outcome Measures

Primary Outcomes (1)

  • Transfer to intensive care unit (y/n)

    Assigned "y" if patient is transferred to an intensive care unit for any length of time; otherwise, assigned "n".

    Upon hospital discharge (median length of stay, 5 days)

Secondary Outcomes (7)

  • Day-weighted proportion of blood glucose values within target range (100-180 mg/dL)

    Upon hospital discharge (median length of stay, 5 days)

  • Proportion of inpatient days involving any hypoglycemia (blood glucose<70 mg/dL)

    Upon hospital discharge (median length of stay, 5 days)

  • Proportion of inpatient days involving severe hypoglycemia (blood glucose<40 mg/dL)

    Upon hospital discharge (median length of stay, 5 days)

  • Proportion of inpatient days involving any hyperglycemia (blood glucose>200 mg/dL)

    Upon hospital discharge (median length of stay, 5 days)

  • Proportion of inpatient days involving severe hyperglycemia (blood glucose>300 mg/dL)

    Upon hospital discharge (median length of stay, 5 days)

  • +2 more secondary outcomes

Study Arms (4)

Historical control group (H)

Winthrop patients with diabetes hospitalized between August 1, 2010 and March 31, 2011

Other: Sliding-Scale Insulin Therapy

Intervention group (I)

Winthrop patients with diabetes hospitalized between August 1, 2011 and March 31, 2012

Other: Physiologic Insulin Therapy

Parallel control group (P-sub-H)

Patients with diabetes hospitalized between August 1, 2010 and March 31, 2011 at 7 control hospitals located in the New York City metropolitan region

Other: Sliding-Scale Insulin Therapy

Parallel control group (I-sub-H)

Patients with diabetes hospitalized between August 1, 2011 and March 31, 2012 at 7 control hospitals located in the New York City metropolitan region

Other: Sliding-Scale Insulin Therapy

Interventions

Physiologic Insulin TherapyOTHER
Intervention group (I)
Sliding-Scale Insulin TherapyOTHER
Historical control group (H)Parallel control group (I-sub-H)Parallel control group (P-sub-H)

Eligibility Criteria

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

Hospitalized patients with type 2 diabetes mellitus admitted to a medical or surgical service

You may qualify if:

  • Type 2 diabetes

You may not qualify if:

  • Pregnant
  • Admitted directly to an intensive care unit
  • Length of stay \<2 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Winthrop-University Hospital

Mineola, New York, 11501, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Hyperglycemia

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Donald A Brand, Ph.D.

    Winthrop University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Health Outcomes Research

Study Record Dates

First Submitted

July 29, 2016

First Posted

August 16, 2016

Study Start

July 1, 2015

Primary Completion

August 15, 2017

Study Completion

June 30, 2018

Last Updated

June 4, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)