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Trial registered on ANZCTR


Registration number
ACTRN12622000445774
Ethics application status
Approved
Date submitted
24/02/2022
Date registered
21/03/2022
Date last updated
5/04/2022
Date data sharing statement initially provided
21/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Self-management of insulin by inpatients with diabetes in acute care – a randomized controlled trial
Scientific title
A randomized controlled trial examining the effectiveness of insulin self-management by adult inpatients with diabetes in acute care for blood glucose control and length of stay.
Secondary ID [1] 306524 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Insulin dependent diabetes 325405 0
Condition category
Condition code
Metabolic and Endocrine 322793 322793 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will involve the diabetic in-patient measuring their own blood glucose levels, determining their own dose of insulin, and administering their insulin dose.

Trial information will be communicated to patients in the Patient Information and Consent Form delivered for this trial.

Patients will initially be assessed using a screening tool designed for this trial. This tool will ascertain if the patient has skills and knowledge necessary for self-administration of insulin and self-monitoring of blood glucose levels.

Clinicians will be assessed on competencies required for monitoring and delivering diabetes care information. If clinicians do not meet the required competencies, additional training will be provided by the Endocrinologist and diabetes educator.

Trial participants in the self-management group will be required to take their own blood glucose measurements and administer their own insulin. A written insulin patient information resource has been developed specifically for this study and will be provided to patients for information on these skills. Patients will only be eligible for the trial if they can independently demonstrate self-management. This will be supervised by nurses on the ward and the doctors of the treating medical team.

Procedures to be undertaken by patients in the self-management group:
- Blood glucose measurement - the patient will prick their finger with a lancet, and will measure the resulting blood sample by putting it on the test strip and inserting into the blood glucose monitor. The result will be recorded in the patient's self-report diary. The record will then be transcribed by the patient's nurse into the electronic medical record. Blood glucose measurement will be undertaken up to 6 times per day as required.
- Insulin dosage administration - the patient will adjust the insulin dosage based on glucose level and food intake as required, and will draw up the correct dose and administer using the injector pen device. The patient's nurse will then record in the electronic medical record the dose that has been delivered. These processes will be undertaken for the duration of the in-patient admission until discharge. Insulin administration will be undertaken up to 3 times per day at meal times as required.

Procedures undertaken by all participants:
- Continuous glucose monitoring - this small wearable device is attached to the skin to measure glucose levels at all times of the day or night. Participants will wear this device for 14 days, and will not see the glucose readings.
Intervention code [1] 322953 0
Treatment: Other
Comparator / control treatment
The control group will receive standard care, whereby blood glucose monitoring, insulin dose determination, and insulin administration is performed by clinicians.
Control group
Active

Outcomes
Primary outcome [1] 330581 0
Percentage of time blood glucose is in range (between 4 mmol/L to 10 mmol/L) assessed using a continuous blood glucose monitor
Timepoint [1] 330581 0
Across the 14-day trial period
Primary outcome [2] 330582 0
Number of hypoglycaemia events (blood glucose level of 3.9 mmol/L or below) assessed using a continuous blood glucose monitor
Timepoint [2] 330582 0
Across the 14-day trial period
Primary outcome [3] 330583 0
Number of hyperglycaemic events (blood glucose level > 10.1 mmol/L) assessed using a continuous blood glucose monitor
Timepoint [3] 330583 0
Across the 14-day trial period
Secondary outcome [1] 406782 0
Length of stay - the duration of a single episode of hospitalization calculated by subtracting day of admission from day of discharge. This will be assessed by accessing hospital records.
Timepoint [1] 406782 0
Measured at discharge
Secondary outcome [2] 406783 0
Hospital readmission within 30 days - a presentation to an acute care hospital within 30 days of discharge from the same or another acute care hospital. This will be assessed by accessing hospital records.
Timepoint [2] 406783 0
30 days from discharge
Secondary outcome [3] 406786 0
Number of clinical incidents - incidents which harm resulted in a person receiving health care. This will be assessed be accessing hospital Riskman reports.
Timepoint [3] 406786 0
Within the patient's admission
Secondary outcome [4] 406787 0
Patient Diabetes Distress Screening Scale
Timepoint [4] 406787 0
At the commencement (Day 0) and conclusion (Day 14) of the trial period
Secondary outcome [5] 406788 0
Number of scheduled blood glucose measurements that were not taken by audit of participant-recorded study-specific blood glucose diary
Timepoint [5] 406788 0
Within the patient's admission
Secondary outcome [6] 406789 0
Number of incorrect insulin dose administrations by audit of participant-recorded study-specific insulin administration diary
Timepoint [6] 406789 0
Within the patient's admission
Secondary outcome [7] 407049 0
Clinician satisfaction – as recorded in the created questionnaire, This will be completed by clinicians who are involved in caring for diabetic patients to give information on staff knowledge of diabetes care, completion of assessment documentation to ascertain level of clinician training, and belief of the value of patient self-management following the research project.
Timepoint [7] 407049 0
Undertaken at the conclusion of the trial data collection period.
Secondary outcome [8] 407050 0
Patient confidence in managing diabetes and related feelings of diabetes self-management. This will be assessed via the Diabetes Distress Screening Scale
Timepoint [8] 407050 0
To be undertaken at the commencement (Day 0) and conclusion (Day 14) of the data collection period for each patient in the intervention and control arms.

Eligibility
Key inclusion criteria
Patients who have been self-managing their insulin prior to admission discharge.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• People who will not be self-managing their insulin on discharge
• People who are confused and not orientated to time and place
• People who lack mental capacity and have inability to provide informed consent
• People admitted with Diabetic Ketoacidosis (DKA) or Hyperosmolar Hyperglycaemic State (HHS) requiring an insulin infusion
• People whose clinical condition deteriorates e.g. becomes confused, more unwell, or dependent on nursing cares
• Physical disabilities that prevents self-administration

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data will be analysed with IBM SPSS version 26 using descriptive statistics for group characteristics, and standard group comparison statistics (dependent on normalised or non-normalised data).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2022
Actual
Date of last participant enrolment
Anticipated
1/10/2022
Actual
Date of last data collection
Anticipated
14/11/2022
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 21836 0
Mackay Base Hospital - Mackay
Recruitment postcode(s) [1] 36895 0
4740 - Mackay

Funding & Sponsors
Funding source category [1] 310867 0
Other Collaborative groups
Name [1] 310867 0
Tropical Australian Academic Health Centre
Country [1] 310867 0
Australia
Primary sponsor type
Hospital
Name
Mackay Hospital and Health Service
Address
Mackay Base Hospital. 475 Bridge Road, Mackay, QLD 4740
Country
Australia
Secondary sponsor category [1] 312130 0
None
Name [1] 312130 0
Address [1] 312130 0
Country [1] 312130 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310430 0
Darling Downs Hospital and Health Service
Ethics committee address [1] 310430 0
Ethics committee country [1] 310430 0
Australia
Date submitted for ethics approval [1] 310430 0
27/01/2022
Approval date [1] 310430 0
16/03/2022
Ethics approval number [1] 310430 0
HREC/2022/QTDD/82253

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

Contacts
Principal investigator
Name 117638 0
Ms Kylie Oliver
Address 117638 0
Mackay Base Hospital
475 Bridge Street, Mackay 4740 QLD
Country 117638 0
Australia
Phone 117638 0
+61 7 4885 7561
Fax 117638 0
Email 117638 0
[email protected]
Contact person for public queries
Name 117639 0
Kylie Oliver
Address 117639 0
Mackay Base Hospital
475 Bridge Street, Mackay 4740 QLD
Country 117639 0
Australia
Phone 117639 0
+61 7 4885 7561
Fax 117639 0
Email 117639 0
[email protected]
Contact person for scientific queries
Name 117640 0
Matthew Hiskens
Address 117640 0
Mackay Base Hospital
475 Bridge Street, Mackay 4740 QLD
Country 117640 0
Australia
Phone 117640 0
+61 7 4885 6793
Fax 117640 0
Email 117640 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All IPD that underlie results in a publication
When will data be available (start and end dates)?
From January 1, 2023 with no end date
Available to whom?
Researchers who provide a methodologically sound proposal to the principal investigator.
Available for what types of analyses?
Data may be available for IPD meta-analyses.
How or where can data be obtained?
By emailing the principal investigator [email protected]


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.