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Trial registered on ANZCTR


Registration number
ACTRN12616001147471
Ethics application status
Approved
Date submitted
27/07/2016
Date registered
23/08/2016
Date last updated
23/08/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Optimizing hyperglycaemia management in the Acute Medical Unit: investigation of barriers to achieving adequate glucose control in patients with diabetes in the acute medical setting; introduction and evaluation of tools to assist clinicians in prescribing insulin
Scientific title
Optimizing hyperglycaemia management in the Acute Medical Unit:: investigation of barriers to achieving adequate glycaemic control in the acute medical setting; introduction and evaluation of tools to assist clinicians in prescribing insulin
Secondary ID [1] 289777 0
none
Universal Trial Number (UTN)
U1111-1185-7905
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
diabetes 299663 0
Condition category
Condition code
Metabolic and Endocrine 299606 299606 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Introduction of specific chart for prescription of subcutaneous insulin, based on National insulin prescription chart, along with education program for medical and nursing staff. The prescription chart enables clinicians (medical staff) to prescribe basal, pre-meal or premixed insulins, along with correction doses of rapid-acting insulin, adjusted on a daily basis. The chart is designed to allow prescription and monitoring of blood glucose levels for 5 days - after which a new chart will be used for the patient. The chart also records blood glucose levels, enabling a comprehensive view of a patient's diabetes management. The chart replaces a conventional drug chart which is not designed for prescription of multiple daily insulin injections, plus a blood glucose monitoring chart. The education program will be delivered by an experienced diabetes nurse educator working in the Acute Medical Unit. The education program consists of a weekly series of tutorials (30 mins) for junior medical staff and nursing staff in the Acute Medical Unit over one month period prior to adoption of the new prescription chart, with follow-up tutorials (twice-monthly) post-adoption of the chart as required (i.e. to educate new staff rotating through to unit and for maintenance of the required standard of insulin prescription). Topics included in the education sessions are: how to prescribe correctly using the chart, how to determine initial insulin doses, how to treat hypoglycaemia, how to treat hyperglycaemia. A register of staff attendance at education sessions will be kept. After a run-in period for the new prescription chart of 1 month, outcomes will be evaluated at + 3 months and +6months i.e. the new chart will continue to be used for 7 month duration of the trial (1 month run-in, then +3 months, + 6 months) i.e. with collection of data September 2016 - February 2017.
Intervention code [1] 295433 0
Treatment: Other
Comparator / control treatment
Data will be collected pre-and post-intervention i.e. patient satisfaction survey, staff attitudes survey, patient blood glucose levels. Historical data re these outcomes was collected January - July 2016. Please note that the control group was initially categorized as Historical as these patients were not receiving care at the same time as the patients receiving the intervention, but has been altered to Active according to the definitions used on this site.
Control group
Active

Outcomes
Primary outcome [1] 299079 0
The primary endpoint will be blood glucose levels pre- and post-implementation of the insulin management protocol. The results of mean blood glucose levels at fasting, nonfasting (i.e. pre-lunch, pre-evening meal and bedtime) per day of admission and mean glucose levels (mean of all glucose levels during the hospital stay) will be compared. This is a composite primary outcome. Blood glucose levels are assessed using a blood glucose meter.
Timepoint [1] 299079 0
Data from 6 months prior to intervention: and from 3 and 6 months post-intervention.
Secondary outcome [1] 326078 0
Secondary endpoints will be the number of hypoglycaemic events (defined as glucose < 4.0 mmol/l), and severe hypoglycaemic events (glucose < 2.8 mmol/l), as assessed using blood glucose meter. This is a composite secondary outcome.
Timepoint [1] 326078 0
Data from 6 months prior to intervention: and from 3 and 6 months post-intervention.
Secondary outcome [2] 326079 0
episodes of severe hyperglycaemia (defined as glucose > 20 mmol/l), as assessed using blood glucose meter.
Timepoint [2] 326079 0
Data from 6 months prior to intervention: and from 3 and 6 months post-intervention.
Secondary outcome [3] 326080 0
length of hospital stay, assessed by review of medical records
Timepoint [3] 326080 0
Data from 6 months prior to intervention: and from 3 and 6 months post-intervention.
Secondary outcome [4] 326082 0
patient satisfaction with diabetes care (assessed by survey). The survey is based on the National Diabetes Inpatient Audit (NaDIA; Diabetes UK) and is used with permission.
Timepoint [4] 326082 0
Data from 6 months prior to intervention: and from 3 and 6 months post-intervention
Secondary outcome [5] 326083 0
clinician knowledge and attitudes re inpatient diabetes care (assessed by a survey designed specifically for this study). This is a composite secondary outcome.
Timepoint [5] 326083 0
Data from 6 months prior to intervention: and from 3 and 6 months post-intervention

Eligibility
Key inclusion criteria
The group of patients will be disparate, reflecting real-world clinical practice i.e. inclusion criteria will be broad:
Patients requiring subcutaneous insulin on admission to AMU – whether or not previously treated with insulin
Patients with known diabetes (Type 1/Type 2) or no previous diagnosis of diabetes.
Duration of admission 48 hours or greater.

Hospital staff to be included in the survey of knowledge/attitudes regarding inpatient diabetes management are: interns and resident medical officers who work in the AMU on rotation, consultant physicians who are permanently based in the AMU, and nursing staff who are permanent AMU staff and also on rotation in the AMU.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients admitted with diabetic ketoacidosis
Patients who are not eating and/or requiring intravenous insulin
Patients whose prognosis is so poor that management of hyperglycaemia is not indicated.

Exclusion criteria for hospital staff are speciality junior medical staff and consultant physicians whose patients are occupying an AMU bed, but are not cared for by the AMU medical staff.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
4/01/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
400
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
TAS
Recruitment hospital [1] 6272 0
Launceston General Hospital - Launceston
Recruitment postcode(s) [1] 13807 0
7250 - Launceston

Funding & Sponsors
Funding source category [1] 294156 0
Charities/Societies/Foundations
Name [1] 294156 0
Clifford Craig Medical Research Trust
Country [1] 294156 0
Australia
Primary sponsor type
Individual
Name
Dr Anne Corbould
Address
Department of Medicine
Launceston General Hospital
Charles St
Launceston TAS 7250
Country
Australia
Secondary sponsor category [1] 292987 0
Individual
Name [1] 292987 0
Fiona Swinton
Address [1] 292987 0
AMU
Launceston General Hospital
Charles Street
l;aunceston TAS 7250
Country [1] 292987 0
Australia
Secondary sponsor category [2] 292990 0
Individual
Name [2] 292990 0
Leigh Kinsman
Address [2] 292990 0
University of Tasmania
Frankland Street
Launceston TAS 7250
Country [2] 292990 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295565 0
University of Tasmania Human Research Ethics Committee
Ethics committee address [1] 295565 0
Ethics committee country [1] 295565 0
Australia
Date submitted for ethics approval [1] 295565 0
Approval date [1] 295565 0
11/12/2015
Ethics approval number [1] 295565 0
H0015375

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 67786 0
Dr Anne Corbould
Address 67786 0
John Morris Diabetes Centre
NICS, Launceston General Hospital
Frankland Street
Launceston TAS 7250
Country 67786 0
Australia
Phone 67786 0
+61 367776777
Fax 67786 0
Email 67786 0
[email protected]
Contact person for public queries
Name 67787 0
Anne Corbould
Address 67787 0
John Morris Diabetes Centre
NICS, Launceston General Hospital
Frankland Street
Launceston TAS 7250
Country 67787 0
Australia
Phone 67787 0
+61 3 67776777
Fax 67787 0
Email 67787 0
[email protected]
Contact person for scientific queries
Name 67788 0
Anne Corbould
Address 67788 0
John Morris Diabetes Centre
NICS, Launceston General Hospital
Frankland Street
Launceston TAS 7250
Country 67788 0
Australia
Phone 67788 0
+61 3 67776777
Fax 67788 0
Email 67788 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.