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Trial registered on ANZCTR


Registration number
ACTRN12624000519550p
Ethics application status
Submitted, not yet approved
Date submitted
27/03/2024
Date registered
26/04/2024
Date last updated
27/10/2024
Date data sharing statement initially provided
26/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Glycaemic impact of a glucose telemetry system amongst hospitalised adults
Scientific title
Efficacy of Early Notification of Low and high Inpatient glycaemia with a Glucose Hospital Telemetry System: the ENLIGHTS RCT
Secondary ID [1] 311630 0
None
Universal Trial Number (UTN)
U1111-1304-9297
Trial acronym
ENLIGHTS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes mellitus 333071 0
Condition category
Condition code
Metabolic and Endocrine 329757 329757 0 0
Diabetes
Public Health 330288 330288 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Glucose telemetry system (GTS): continuous glucose monitor-based in-hospital glucose telemetry system providing real-time high/low-glucose alerts to ward nursing staff, in addition to standard care.
The GTS will be comprised of a Dexcom G7 continuous glucose monitor (CGM) applied to the patient; a CGM receiver (smartphone) by the patient bedside with the Dexcom Clarity app and Dexcom G7 app installed and connected via Bluetooth to the participant’s CGM; and a tablet device at the nursing station, connected to the hospital Wi-Fi network, with Dexcom Follow app installed.
The GTS will be programmed to provide nursing staff with real-time low-glucose and high-glucose alerts through a notification on the tablet device. Additionally, the GTS provides glucose trend arrow displays on the nursing station telemetry monitor which can be used to adjust supplemental doses of insulin as needed.
The intervention will run for the duration of the participant's inpatient stay on the study ward, up to a maximum of 10 days.
Intervention code [1] 328091 0
Treatment: Devices
Comparator / control treatment
Standard care: routine ward-based fingerprick capillary glucose monitoring, typically 4-5 times per day
Control group
Active

Outcomes
Primary outcome [1] 337820 0
CGM time-in-range (BGL 3.9 - 13.9 mmol/L)
Timepoint [1] 337820 0
For the duration of inpatient stay on the study ward, up to a maximum of 10 days of study participation
Secondary outcome [1] 433396 0
CGM time-in-range (BGL 3.9-10.0 mmol/L)
Timepoint [1] 433396 0
For the duration of inpatient stay on the study ward, up to a maximum of 10 days of study participation
Secondary outcome [2] 433397 0
CGM time-above-range (BGL >10.0mmol/L)
Timepoint [2] 433397 0
For the duration of inpatient stay on the study ward, up to a maximum of 10 days of study participation
Secondary outcome [3] 433398 0
CGM time-below-range (BGL <3.9mmol/L)
Timepoint [3] 433398 0
For the duration of inpatient stay on the study ward, up to a maximum of 10 days of study participation
Secondary outcome [4] 433399 0
Blood glucose levels
Timepoint [4] 433399 0
CGM will be recorded for the duration of inpatient stay on the study ward, up to a maximum of 10 days of study participation. POC testing will be performed as per routine ward care, typically 4-5 times per day
Secondary outcome [5] 433400 0
Number of hypoglycaemic events (BGL 3.0-3.8mmol/L)
Timepoint [5] 433400 0
For the duration of inpatient stay on the study ward, up to a maximum of 10 days of study participation
Secondary outcome [6] 433401 0
Number of hyperglycaemic events (BGL 10.1-13.9mmol/L)
Timepoint [6] 433401 0
For the duration of inpatient stay on the study ward, up to a maximum of 10 days of study participation
Secondary outcome [7] 434187 0
CGM time-above-range (BGL >13.9mmol/L)
Timepoint [7] 434187 0
For the duration of inpatient stay on the study ward, up to a maximum of 10 days of study participation
Secondary outcome [8] 434188 0
CGM time-above-range (BGL >18mmol/L)
Timepoint [8] 434188 0
For the duration of inpatient stay on the study ward, up to a maximum of 10 days of study participation
Secondary outcome [9] 434189 0
CGM time-below-range (BGL <3.0mmol/L)
Timepoint [9] 434189 0
For the duration of inpatient stay on the study ward, up to a maximum of 10 days of study participation
Secondary outcome [10] 434190 0
Number of hypoglycaemic events (BGL <3.0mmol/L)
Timepoint [10] 434190 0
For the duration of inpatient stay on the study ward, up to a maximum of 10 days of study participation
Secondary outcome [11] 434191 0
Number of hyperglycaemic events (BGL >13.9mmol/L)
Timepoint [11] 434191 0
For the duration of inpatient stay on the study ward, up to a maximum of 10 days of study participation
Secondary outcome [12] 434192 0
Number of hyperglycaemic events (BGL >18.0mmol/L)
Timepoint [12] 434192 0
For the duration of inpatient stay on the study ward, up to a maximum of 10 days of study participation

Eligibility
Key inclusion criteria
Non-critical care adult inpatients
Diabetes mellitus (any aetiology) treated with multiple daily injections of insulin
Admitted under the Endocrinology, Diabetic Foot, Nephrology units on the study ward
Anticipated length of stay 3 days or greater
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Insulin pump use
Scheduled for any MRI scan in next 72 hours, or CT scan of the same region where CGM sensor is located
Receiving hydroxyurea
Receiving peritoneal dialysis
Palliative care
Current active inpatient CGM use
Inability to give informed consent
Unwilling/unable to wear CGM for duration of the study

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)
Sealed envelope method
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated block randomisation
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
Statistical analysis will be performed within an estimand framework.
For the primary and secondary efficacy estimand analyses involving time-in-range, time-above-range and time-below-range, the difference in medians between the intervention and control arms will be estimated using quantile (median) regression adjusted for age, diabetes aetiology and admitting unit.
For secondary efficacy estimand analyses involving hypoglycaemic and hyperglycaemic events, the difference in event rates between the intervention and control arms will be estimated using Negative Binomial Regression with CGM sensor-active time as the exposure offset term, count of events as the dependent variable, treatment arm as the independent variable, and age, diabetes aetiology and admitting unit as adjustment covariates. Should zero counts of events be over-represented in the event distributions, a zero-inflated model will be used as described above.
For the primary and secondary efficacy estimands, additional sensitivity analyses will be conducted excluding those participants with <70% CGM data capture for the period of their trial participation.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/12/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
292
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 315953 0
Government body
Name [1] 315953 0
Australian Government Department of Education - Research Training Program
Country [1] 315953 0
Australia
Funding source category [2] 315955 0
University
Name [2] 315955 0
University of Melbourne
Country [2] 315955 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Melbourne Health
Address
Country
Australia
Secondary sponsor category [1] 318367 0
None
Name [1] 318367 0
Address [1] 318367 0
Country [1] 318367 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 314781 0
The Royal Melbourne Hospital Human Research Ethics Committee
Ethics committee address [1] 314781 0
Ethics committee country [1] 314781 0
Australia
Date submitted for ethics approval [1] 314781 0
03/04/2024
Approval date [1] 314781 0
Ethics approval number [1] 314781 0

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

Contacts
Principal investigator
Name 132706 0
A/Prof Spiros Fourlanos
Address 132706 0
Melbourne Health. 300 Grattan Street, Parkville VIC 3052
Country 132706 0
Australia
Phone 132706 0
+61 3 93427365
Fax 132706 0
Email 132706 0
spiros.fourlanos@mh.org.au
Contact person for public queries
Name 132707 0
Spiros Fourlanos
Address 132707 0
Melbourne Health. 300 Grattan Street, Parkville VIC 3052
Country 132707 0
Australia
Phone 132707 0
+61 3 93427365
Fax 132707 0
Email 132707 0
spiros.fourlanos@mh.org.au
Contact person for scientific queries
Name 132708 0
Spiros Fourlanos
Address 132708 0
Melbourne Health. 300 Grattan Street, Parkville VIC 3052
Country 132708 0
Australia
Phone 132708 0
+61 3 93427365
Fax 132708 0
Email 132708 0
spiros.fourlanos@mh.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21994Study protocol  spiros.fourlanos@mh.org.au



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.