NCT01407289

Brief Summary

The purpose of the study is to compare the efficacy of enhanced published best practice paper-based insulin titration protocol for glycaemic control in hospitalised patients with type 2 diabetes for the length of hospital stay.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
74

participants targeted

Target at P25-P50 for phase_4 diabetes-mellitus-type-2

Timeline
Completed

Started Jun 2011

Shorter than P25 for phase_4 diabetes-mellitus-type-2

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, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 19, 2011

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 2, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

February 5, 2013

Status Verified

April 1, 2012

Enrollment Period

10 months

First QC Date

July 19, 2011

Last Update Submit

February 4, 2013

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Mean blood glucose

    Mean blood glucose over 24 hours

    duration of hospital stay (48 hours - maximum three weeks)

Secondary Outcomes (1)

  • Number of glucose measurements in hyperglycaemic ranges

    duration of hospital stay (48 hours - maximum three weeks)

Study Arms (2)

Insulin titration protocol

EXPERIMENTAL

Patients in care at the Division of Endocrinology will be treated by enhanced version of published best paper based practice insulin titration protocol to control glycaemia in hospitalised patients with type 2 diabetes.

Drug: Insulin Aspart, Insulin Glargine

Standard care

NO INTERVENTION

Patients in care of the Division of Cardiology will be treated using antihyperglycaemic therapy according to standard care.

Interventions

Insulin Aspart, Insulin GlargineDRUG

The Intervention is a paper based protocol, which provides suggestions for new insulin doses (basal-bolus regime).

Insulin titration protocol

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes
  • Blood glucose in the range between 140 - 400 mg/dl
  • Expected stay ≥ 48 hours

You may not qualify if:

  • Hyperglycemia without known history of type 2 diabetes mellitus
  • Impaired renal function (serum creatinine ≥3.0mg/dL)
  • Clinically relevant hepatic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Graz, Division of Internal Medicine, Department of Endocrinology and Metabolism/ Cardiology

Graz, 8036, Austria

Location

Related Publications (2)

  • Donsa K, Beck P, Holl B, Mader JK, Schaupp L, Plank J, Neubauer KM, Baumgartner C, Pieber TR. Impact of errors in paper-based and computerized diabetes management with decision support for hospitalized patients with type 2 diabetes. A post-hoc analysis of a before and after study. Int J Med Inform. 2016 Jun;90:58-67. doi: 10.1016/j.ijmedinf.2016.03.007. Epub 2016 Mar 23.

    PMID: 27103198DERIVED

  • Schaupp L, Donsa K, Neubauer KM, Mader JK, Aberer F, Holl B, Spat S, Augustin T, Beck P, Pieber TR, Plank J. Taking a Closer Look--Continuous Glucose Monitoring in Non-Critically Ill Hospitalized Patients with Type 2 Diabetes Mellitus Under Basal-Bolus Insulin Therapy. Diabetes Technol Ther. 2015 Sep;17(9):611-8. doi: 10.1089/dia.2014.0343. Epub 2015 Apr 30.

    PMID: 25927357DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin AspartInsulin Glargine

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsInsulin, Long-Acting

Study Officials

  • Thomas Pieber, MD

    Division of Endocrinology and Metabolism, Department of Internal Medicine Medical University of Graz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Prof. of Medicine

Study Record Dates

First Submitted

July 19, 2011

First Posted

August 2, 2011

Study Start

June 1, 2011

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

February 5, 2013

Record last verified: 2012-04

Locations

AU(1)