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Trial registered on ANZCTR


Registration number
ACTRN12623001148662
Ethics application status
Approved
Date submitted
10/10/2023
Date registered
6/11/2023
Date last updated
6/11/2023
Date data sharing statement initially provided
6/11/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Personalising advice to target hyperglycaemia in children and adolescents with type 1 diabetes: the role of gastric emptying
Scientific title
Feasibility of using the correlation between CGM metrices and the gastric half-emptying time to personalise advice targeting hyperglycaemia in children and adolescents with type 1 diabetes
Secondary ID [1] 310765 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes 331725 0
Condition category
Condition code
Metabolic and Endocrine 328472 328472 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be recruited who access the diabetes services in Western Australia, wear continuous glucose monitor (CGM) for > 75% of the time and satisfy the inclusion criteria.

The study will involve a one week run in period to optimise participants insulin settings profiles, Participants will have regular telephone contact with the study doctor to review glucose levels. Where indicated adjustments will be made to insulin settings to optimise basal insulin dose, insulin to carbohydrate ratios and insulin sensitivity factors. This will improve the likelihood of the participants blood glucose level being in the target range between 5-10mmol/L on the study day.

For the study visit all participants will arrive early morning after an overnight fast at the outpatient clinic for approximately 5 hours. Participants will consume a standardised solid meal within 10 minutes and gastric emptying will be quantified . Gastric emptying will be measured for up to 4 hours after meal consumption using the validated breath test technique. CGM data will be exported to assess postprandial glycaemic profiles. Blood glucose levels will be measured analogue to the breath test using a glucose oxidase analyser (YSI). Additionally, blood will be collected to measure concentration of gut hormones GLP-1 and GIP. Validated questionnaires will assess meal-related GE symptoms including nausea, bloating and postprandial fullness.
The project will be supervised by the principal investigator(s) to ensure it is conducted in compliance with the protocol, GCP and regulatory requirements. Information on participant recruitment and retention, participant safety and data collection will be collated and reviewed on a regular basis. All staff will be trained to ensure appropriate data collection in accordance with ICH-GCP guidelines. They will be trained on how to fill out the CRFs to ensure quality of data
Intervention code [1] 327171 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 336291 0
Gastric half-emptying time .
Timepoint [1] 336291 0
-10 minutes, 15 minutes, 30 minutes, 60 minutes, 75 minutes, 90 minutes, 120 minutes, 180 minutes and 240 minutes post meal consumption.
Secondary outcome [1] 427711 0
Gastrointestinal symptoms (fullness, nausea, bloating, appetite, heartburn and bowel motion)
This will be assessed as a composite outcome.
Timepoint [1] 427711 0
At 30 minutes, 60 minutes, 120 minutes, 180minutes and 240 minutes after meal consumption
Secondary outcome [2] 427721 0
Concentration of gut hormones GLP-1 and GIP
Timepoint [2] 427721 0
At 30 minutes, 60 minutes, 120 minutes, 180 minutes and 240 minutes after meal consumption.
Compared to baseline (-10 minutes).
Secondary outcome [3] 428123 0
Postprandial glucose change
Timepoint [3] 428123 0
At 15 minutes, 30 minutes, 45 minutes, 60 minutes, 75 minutes, 90 minutes, 105 minutes, 120 minutes, 150 minutes, 180 minutes, 210 minutes and 240 minutes after meal consumption.

Eligibility
Key inclusion criteria
Type 1 diabetes for at least 1 year
Most recent HbA1c <9% within the last 3 months
using Hybrid closed system for at least 3 months
Using a Dexcom G6 CGM >75% of the time
Minimum age
12 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Presence of a disease affecting the digestion and absorption of nutrients, including coeliac disease and gastroparesis
An allergy or intolerance to the study meal
Medications intentionally affecting GE (e.g prokinetic agents) or medications that alter GE as a side effect (e.g narcotic analgesics)
Not using CGM

Study design
Purpose of the study
Educational / counselling / training
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size for this exploratory study will be n=13, which the research team agree is feasible and achievable over the proposed data collection period. The study has been powered to detect a medium to large effect size using the linear Pearson correlation methods (coefficient r = 0.7). To allow this, 13 participants will be recruited.
Mean and SEs (normally distributed variables) and median and interquartile ranges will be reported.
After the study day, CGM data will be downloaded as Microsoft Excel spreadsheet. For further analysis, the data will be then analysed with statistical software (SPSS).
The 13CO2 exception rate will be used to calculate the gastric half emptying time (T1/2) using a non-linear regression model.
Exploration of bivariate associations between the CGM metrices and T1/2will be achieved through Pearson product-moment correlation
Multiple linear regression will be used to analyse relationship between gastric-half emptying time (T1/2), Gastrointestional (GI) symptoms and postprandial change in BGL.
The sample size for this exploratory study will be n=13, which the research team agree is feasible and achievable over the proposed data collection period. The study has been powered to detect a medium to large effect size using the linear Pearson correlation methods (coefficient r = 0.7). To allow this, 13 participants will be recruited.
P values of < 0.05 will be used to determine statistical significance.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2023
Actual
Date of last participant enrolment
Anticipated
29/04/2024
Actual
Date of last data collection
Anticipated
13/05/2024
Actual
Sample size
Target
13
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 314995 0
Other Collaborative groups
Name [1] 314995 0
Telethon Kids Institute, Rio Tinto Children's Diabetes Centre-a JDRF Global Centre of Excellence
Country [1] 314995 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Telethon Kids Institute, Rio Tinto Children's Diabetes Centre-a JDRF Global centre of Excellence
Address
15 Hospital Avenue, 6009 Nedlands Perth, Western Australia
Country
Australia
Secondary sponsor category [1] 317017 0
None
Name [1] 317017 0
Address [1] 317017 0
Country [1] 317017 0
Other collaborator category [1] 282843 0
Individual
Name [1] 282843 0
Prof Michael Horowitz
Address [1] 282843 0
University of Adelaide, 115 Grenfall Street, 5005 Adelaide, South Australia
Country [1] 282843 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313968 0
Children and Adolescent Health Service HREC (00268)
Ethics committee address [1] 313968 0
Perth Children' s Hospital. 15 Hospital Avenue, Perth, 6009 WA
Ethics committee country [1] 313968 0
Australia
Date submitted for ethics approval [1] 313968 0
17/04/2023
Approval date [1] 313968 0
17/07/2023
Ethics approval number [1] 313968 0
RGS0000006058

Summary
Brief summary
Gastric emptying (GE) is believed to be a potential mechanism causing individual differences in insulin requirements. However, the role of GE in personalising diabetes management is not well understood, and feasible ways to assess GE in children with T1D in a clinical setting are needed.
This project aims to study GE in adolescents with type 1 diabetes (T1D) to examine the relationship between GE and blood glucose levels (BGLs) after eating a mixed meal, and to determine if continuous glucose monitoring (CGM) can be helpful in identifying rates of individuals GE. Thirteen T1D participants using a hybrid close loop system (HCL) will consume a standard meal, and both GE using the breath test technique, and BGLs will be monitored over the subsequent 4 hours. Changes in glucose levels will be monitored by CGM and regular blood sampling throughout the study. CGM traces will be assessed in its potential to use as a marker of GE.
The outcomes will provide important information about GE characteristics in young people with T1D and its potential to optimise current strategies of insulin delivery.
Trial website
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 129958 0
A/Prof Elizabeth Davis
Address 129958 0
Perth Children's Hospital, 15 Hospital Avenue, 6009 Nedlands, Western Austrlia
Country 129958 0
Australia
Phone 129958 0
+61 8 6456 5031
Fax 129958 0
Email 129958 0
Elizabeth.Davis@health.wa.gov.au
Contact person for public queries
Name 129959 0
Dr Sabrina Binkowski
Address 129959 0
Telethon Kids Institute 15 Hospital Avenue, 6009 Nedlands , Western Australia
Country 129959 0
Australia
Phone 129959 0
+61 8 6456 4617
Fax 129959 0
Email 129959 0
Sabrina.Binkowski@telethonkids.org.au
Contact person for scientific queries
Name 129960 0
Dr Sabrina Binkowski
Address 129960 0
Telethon Kids Institute 15 Hospital Avenue, 6009 Nedlands, Western Australia
Country 129960 0
Australia
Phone 129960 0
+61 8 6456 4617
Fax 129960 0
Email 129960 0
Sabrina.Binkowski@telethonkids.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?

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.