ANZCTR - Registration

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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]

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

Condition category

Condition code

Metabolic and Endocrine

Diabetes

Public Health

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]

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]

CGM time-in-range (BGL 3.9 - 13.9 mmol/L)

Timepoint [1]

For the duration of inpatient stay on the study ward, up to a maximum of 10 days of study participation

Secondary outcome [1]

CGM time-in-range (BGL 3.9-10.0 mmol/L)

Timepoint [1]

For the duration of inpatient stay on the study ward, up to a maximum of 10 days of study participation

Secondary outcome [2]

CGM time-above-range (BGL >10.0mmol/L)

Timepoint [2]

For the duration of inpatient stay on the study ward, up to a maximum of 10 days of study participation

Secondary outcome [3]

CGM time-below-range (BGL <3.9mmol/L)

Timepoint [3]

For the duration of inpatient stay on the study ward, up to a maximum of 10 days of study participation

Secondary outcome [4]

Blood glucose levels

Timepoint [4]

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]

Number of hypoglycaemic events (BGL 3.0-3.8mmol/L)

Timepoint [5]

For the duration of inpatient stay on the study ward, up to a maximum of 10 days of study participation

Secondary outcome [6]

Number of hyperglycaemic events (BGL 10.1-13.9mmol/L)

Timepoint [6]

For the duration of inpatient stay on the study ward, up to a maximum of 10 days of study participation

Secondary outcome [7]

CGM time-above-range (BGL >13.9mmol/L)

Timepoint [7]

For the duration of inpatient stay on the study ward, up to a maximum of 10 days of study participation

Secondary outcome [8]

CGM time-above-range (BGL >18mmol/L)

Timepoint [8]

For the duration of inpatient stay on the study ward, up to a maximum of 10 days of study participation

Secondary outcome [9]

CGM time-below-range (BGL <3.0mmol/L)

Timepoint [9]

For the duration of inpatient stay on the study ward, up to a maximum of 10 days of study participation

Secondary outcome [10]

Number of hypoglycaemic events (BGL <3.0mmol/L)

Timepoint [10]

For the duration of inpatient stay on the study ward, up to a maximum of 10 days of study participation

Secondary outcome [11]

Number of hyperglycaemic events (BGL >13.9mmol/L)

Timepoint [11]

For the duration of inpatient stay on the study ward, up to a maximum of 10 days of study participation

Secondary outcome [12]

Number of hyperglycaemic events (BGL >18.0mmol/L)

Timepoint [12]

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?

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]

Government body

Name [1]

Australian Government Department of Education - Research Training Program

Address [1]

Country [1]

Australia

Funding source category [2]

University

Name [2]

University of Melbourne

Address [2]

Country [2]

Australia

Primary sponsor type

Other Collaborative groups

Name

Melbourne Health

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

The Royal Melbourne Hospital Human Research Ethics Committee

Ethics committee address [1]

https://www.thermh.org.au/research/researchers/ethics

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

03/04/2024

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

This study aims to answer the question: Does use of a glucose telemetry system amongst hospitalised patients with diabetes mellitus treated with multiple daily injections of insulin improve glycaemic outcomes? Eligible participants will be randomised to the glucose telemetry system or to usual care. The glucose telemetry system will provide nursing staff with real-time glucose alerts to facilitate inpatient diabetes care. We will assess whether use of a glucose telemetry system improves inpatient glycaemia. We hypothesise that use of a glucose telemetry system in hospital will improve CGM-based glycaemic outcomes.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Spiros Fourlanos

Address

Melbourne Health. 300 Grattan Street, Parkville VIC 3052

Country

Australia

Phone

+61 3 93427365

Fax

[email protected]

Contact person for public queries

Name

Spiros Fourlanos

Address

Melbourne Health. 300 Grattan Street, Parkville VIC 3052

Country

Australia

Phone

+61 3 93427365

Fax

[email protected]

Contact person for scientific queries

Name

Spiros Fourlanos

Address

Melbourne Health. 300 Grattan Street, Parkville VIC 3052

Country

Australia

Phone

+61 3 93427365

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
21994	Study protocol			[email protected]

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.

Trial Review

Documents added manually

Documents added automatically