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Trial registered on ANZCTR


Registration number
ACTRN12621000061831
Ethics application status
Approved
Date submitted
12/10/2020
Date registered
25/01/2021
Date last updated
25/01/2021
Date data sharing statement initially provided
25/01/2021
Date results information initially provided
25/01/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Postprandial Glucose Excursions with Difficult Foods in Children with Type 1 Diabetes on Hybrid Closed Loop Therapy: A Pilot Study.
Scientific title
Postprandial Glucose Excursions with Difficult Foods in Children with Type 1 Diabetes on Hybrid Closed Loop Therapy: A Pilot Study.
Secondary ID [1] 302481 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes
Postprandial hyperglycaemia after eating high fat and high protein meals
319317 0
Condition category
Condition code
Metabolic and Endocrine 317288 317288 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is a quantitative prospective cross-over design study under free-living conditions.

Participants will be using their personal Medtronic MiniMed 670G insulin pump and their Guardian G3 continuous glucose monitoring (CGM) sensor. Each participant will be re-educated by an accredited practising dietitian on how to bolus for high fat and high protein meals using standard insulin pump therapy (Manual Mode). This will be a 20 minute phone call with each participant. After this, they will have a 2 week run-in period to help optimise their pump settings before commencing the study.

Study participants are randomised to begin the study in either Manual Mode or Auto Mode (Hybrid Closed Loop therapy). Participants will be asked to consume 2 standardised frozen beef lasagne meals and 2 standardised frozen margarita pizza meals in each Mode at dinner time (4 dinner study meals in Manual Mode, 4 dinner study meals in Auto Mode). This is a total of 2 nights a week for 4 weeks. There will be no wash out period between the meals as we will not be comparing the effects of a control drug to an intervention drug.

Postprandial glucose excursions after eating each study meal in Auto and Manual Mode will be compared. Regular phone calls and text messages will be made to each family after each meal to monitor adherence to the intervention.
Intervention code [1] 318773 0
Lifestyle
Intervention code [2] 318774 0
Treatment: Devices
Comparator / control treatment
Each participant is acting as their own control as it is a cross over study and all participants will take part in both treatment groups. No mode is considered the control treatment.
Control group
Active

Outcomes
Primary outcome [1] 325340 0
CGM sensor data will be downloaded from the participant's pump and uploaded onto to CareLink. This data will then be downloaded for analysis.

The primary outcome will be area under the curve based on the excursion values. This is equivalent to the ‘net incremental area under the blood glucose curve above baseline’ (iAUC): areas above baseline are given positive values and those below the baseline are given negative values and these are summed to calculate iAUC.
Timepoint [1] 325340 0
420 minutes (7 hours) after eating study meal
Secondary outcome [1] 387582 0
1. Percentage of time in range (3.9-10mmol/L) from baseline to 420 minutes after each of the test meals

Timepoint [1] 387582 0
All secondary time points will be during the 7 hour postprandial period after eating each study meal. This will be downloaded from each participant's CGM sensor data.
Secondary outcome [2] 388985 0
2. Peak glucose excursion with each meal
Timepoint [2] 388985 0
All secondary time points will be during the 7 hour postprandial period after eating each study meal. This will be downloaded from each participant's CGM sensor data.
Secondary outcome [3] 388986 0
3. Time to peak glucose excursion with each meal
Timepoint [3] 388986 0
All secondary time points will be during the 7 hour postprandial period after eating each study meal. This will be downloaded from each participant's CGM sensor data.
Secondary outcome [4] 388987 0
4. Number of exits from Auto Mode secondary to post-prandial hyperglycaemia
Timepoint [4] 388987 0
All secondary time points will be during the 7 hour postprandial period after eating each study meal. This will be downloaded from each participant's CGM sensor data.
Secondary outcome [5] 388988 0
5. Number of additional insulin boluses delivered as corrections in the 420 minutes following each test meal
Timepoint [5] 388988 0
All secondary time points will be during the 7 hour postprandial period after eating each study meal. This will be downloaded from each participant's CGM sensor data.
Secondary outcome [6] 388989 0
6. Number of hypoglycaemic events (sensor glucose <3mmol/L for >20 minutes)
Timepoint [6] 388989 0
All secondary time points will be during the 7 hour postprandial period after eating each study meal. This will be downloaded from each participant's CGM sensor data.

Eligibility
Key inclusion criteria
• Type 1 diabetes for more than 1 year
• Aged 8 to 18 years
• HbA1c less than or equal to 8.5%
• On hybrid closed loop therapy for more 1 month and using Auto Mode
• Willing and able to consume the test meals containing meat and gluten (pizza and pasta)
• Non Halal and non Kosher
• Access to internet


Minimum age
8 Years
Maximum age
18 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Patients with dietary restrictions (e.g. coeliac disease) – test meals contain gluten
• Patients with clinical gastroparesis

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)
permuted block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
free living study design
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The effect of meal type on iAUC will be tested using a generalised linear mixed model to account for the repeated measurements on the same participants. The outcome in the model will be iAUC based on glucose excursion, and the main predictor will meal type, which will be included as a four-level factor; fixed effects terms for period and sequence and a random effect for participant will also be included to account for the crossover design of the study.

Generalised linear mixed models will also be used to test for differences in mean peak glucose excursions and mean time to peak glucose excursions and to explore patterns of glucose excursions as a function of time post-meal consumption. Differences between meal types in the proportion of subjects who have a hypoglycaemic event will be examined using a logistic regression model within a generalised estimating equation framework. P-values <0.05 will be considered statistically significant.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 17754 0
Perth Children's Hospital - Nedlands
Recruitment postcode(s) [1] 31617 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 306948 0
Other Collaborative groups
Name [1] 306948 0
Telethon Kids Institute
Address [1] 306948 0
Perth Children's Hospital
15 Hospital Avenue
Nedlands 6009 WA
Country [1] 306948 0
Australia
Funding source category [2] 306949 0
University
Name [2] 306949 0
The University of Western Australia
Address [2] 306949 0
35 Stirling Hwy, Crawley WA, 6009
Country [2] 306949 0
Australia
Funding source category [3] 306950 0
Charities/Societies/Foundations
Name [3] 306950 0
JDRF Australia
Address [3] 306950 0
Level 4, 80 Chandos Street
St Leonards, NSW, 2065
Country [3] 306950 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Telethon Kids Institute
Address
Perth Children's Hospital
15 Hospital Avenue
Nedlands 6009 WA
Country
Australia
Secondary sponsor category [1] 307464 0
None
Name [1] 307464 0
Address [1] 307464 0
Country [1] 307464 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307058 0
WA Department of Health Human Research Ethics Committee
Ethics committee address [1] 307058 0
Department of Health
Level 1 C Block
189 Royal Street
East Perth Western Australia 6004
P: 08 9222 4278
Ethics committee country [1] 307058 0
Australia
Date submitted for ethics approval [1] 307058 0
20/01/2020
Approval date [1] 307058 0
23/04/2020
Ethics approval number [1] 307058 0
3825

Summary
Brief summary
Families of children with type 1 diabetes (T1D) have reported high fat and high protein (HF/HP) meals as ‘difficult’ foods, causing prolonged hyperglycaemia after eating. A newly developed Hybrid Closed Loop (HCL) system with an Auto-Mode function uses real-time glucose levels to deliver basal insulin in micro amounts. Yet, there is little evidence on whether Auto-Mode is more effective than standard insulin pump therapy (Manual Mode) at reducing glucose excursions caused by HF/HP foods. This pilot study examines the impact of Auto-Mode on glucose excursions following HF/HP meals compared to Manual Mode.
Participants are asked to consume standardised frozen beef lasagne and margherita pizza two nights a week for four weeks, under controlled conditions (4 meals in Manual Mode, 4 meals in Auto-Mode).

It is hypothesised that the use of the Auto Mode will reduce glucose excursions after eating HF/HP foods when compared to the participant’s preferred insulin bolus pattern delivery in Manual Mode.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 105882 0
Dr Amelia Harray
Address 105882 0
Telethon Kid's Institute
Northern Entrance
Perth Children's Hospital
15 Hospital Avenue
Nedlands WA 6009
Country 105882 0
Australia
Phone 105882 0
+61 8 64565882
Fax 105882 0
Email 105882 0
Amelia.Harray@telethonkids.org.au
Contact person for public queries
Name 105883 0
Miss Rachel Lim
Address 105883 0
Telethon Kid's Institute
Northern Entrance
Perth Children's Hospital
15 Hospital Avenue
Nedlands WA 6009
Country 105883 0
Australia
Phone 105883 0
+61 476799713
Fax 105883 0
Email 105883 0
rachel.lim@telethonkids.org.au
Contact person for scientific queries
Name 105884 0
Dr Mary Abraham and Amelia Harray
Address 105884 0
Perth Children's Hospital
15 Hospital Avenue
Nedlands WA 6009
Country 105884 0
Australia
Phone 105884 0
+61 864565027
Fax 105884 0
Email 105884 0
mary.abraham@health.wa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
IPD data will not be shared. In the instance that this changes, amendments to ethics will be submitted. The individual participant data for this study will not be publically available
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary
Results are yet be to finalised