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Trial registered on ANZCTR


Registration number
ACTRN12615000666527
Ethics application status
Approved
Date submitted
16/06/2015
Date registered
26/06/2015
Date last updated
26/06/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
In people with type 1 diabetes, can an artificial pancreas algorithm improve postprandial glycaemic control following an unannounced meal compared with traditional carbohydrate counting?
Scientific title
In people with type 1 diabetes, can an artificial pancreas algorithm improve postprandial glycaemic control following an unannounced meal compared with traditional carbohydrate counting?
Secondary ID [1] 286913 0
Nil
Universal Trial Number (UTN)
Trial acronym
SCENIC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 diabetes 295334 0
Condition category
Condition code
Metabolic and Endocrine 295601 295601 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Hunter New England Diabetes Research Network (HNEHRN) has developed a novel artificial pancreas algorithm with multiple future food and exercise scenarios called scenario based moving horizon stochastic dynamic programming (SCENIC). SCENIC will allow the integration of multiple inputs, learnt responses and patterning data so the system can cope with events such as food and exercise without hypoglycaemia. This study will determine if SCENIC is capable of maintaining glycaemic control during a meal.
Participants will attend the Hunter Medical Research Institute for 5 consecutive evenings at 4pm, having fasted and not adjusted their insulin since 1pm. Participants will have their blood glucose levels monitored using capillary blood sampling and a glucometer at 15 min intervals from 4-5pm. At 5pm, participants will be given the standardised test meal and their blood glucose levels will continue to be monitored at 15 min intervals until 9pm.
On the first night, no mealtime insulin dose will be administered. On the second night, the usual mealtime insulin bolus will be administered according the the participant's usual clinical care. On nights 3-5, the insulin dose will be determined using SCENIC.
In the event of hypoglycaemia prior to the session, the session will be rescheduled. In the event of hypoglycaemia during a session, the session will be terminated and the participant treated according to their routine clinical care.
Intervention code [1] 292099 0
Treatment: Devices
Comparator / control treatment
The comparator is usual care for mealtime insulin dosing in type 1 diabetes. This consists of the individualised insulin: carbohydrate ratio with a correction bolus for pre-meal hyperglycaemia.
Control group
Active

Outcomes
Primary outcome [1] 295312 0
Mean blood glucose level
Timepoint [1] 295312 0
30 minute intervals for 4 hours commencing at the time of the meal
Secondary outcome [1] 315332 0
Incidence of hypoglycaemia (<4 mmol/L) measured through capillary blood sampling and a glucometer.
Timepoint [1] 315332 0
30 minutes intervals for 4 hours commencing at the time of the meal
Secondary outcome [2] 315333 0
Peak blood glucose level
Timepoint [2] 315333 0
30 minute intervals over 4 hours commencing at the time of the meal
Secondary outcome [3] 315334 0
Time to peak blood glucose level
Timepoint [3] 315334 0
30 minute intervals over 4 hours commencing at the time of the meal
Secondary outcome [4] 315335 0
Incremental area under the curve above the target blood glucose level (10 mmol/L)
Timepoint [4] 315335 0
30 minute intervals over 4 hours commencing at the time of the meal
Secondary outcome [5] 315336 0
Incremental area under the curve below the target blood glucose level (4 mmol/L)
Timepoint [5] 315336 0
30 minute intervals over 4 hours commencing at the time of the meal
Secondary outcome [6] 315337 0
Blood glucose level at conclusion of trial
Timepoint [6] 315337 0
4 hours postprandially (i.e. 9pm)

Eligibility
Key inclusion criteria
1. Type 1 diabetes mellitus for over 1 year
2. HbA1c less than or equal to 69 mmol/mol (8.5%)
3. Age 12y to 45yo
4. Body mass index less than or equal to 97th percentile
5. No other medical conditions
6. No diabetes complications
Minimum age
12 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Unwilling/unable to comply with study protocol
2. HbA1c > 69 mmol/mol (> 8.5%)
3. Any medical condition other than type 1 diabetes
4. Diabetes complications including gastroparesis
5. Medications that would alter glycaemic response

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Eligible subjects and their families will be approached by the research nurse and/or principal investigator and they will be provided with a verbal explanation of the study as well as written information sheets. Once they have been given sufficient time to consider their participation in the trial (more than 24 hours), the parents/guardians will be asked to provide written informed consent and children to provide evidence of their assent to the study procedures. Adult participants will sign a consent form. Written consent will be obtained at or before Visit 1.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
This is a repeated measures trial - all participants will complete all test sessions in the required order (1. No insulin dose, 2. Insulin dose as per usual clinical care, 3-5. Insulin dose as per SCENIC algorithm)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
This is a repeated measures trial - all participants will complete all test sessions in the required order (1. No insulin dose, 2. Insulin dose as per usual clinical care, 3-5. Insulin dose as per SCENIC algorithm). Each subject acts as their own control.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Nine participants are required to provide 80% power to detect a 50% improvement in the proportion of time spent in the normal blood glucose range (4-10mmol/L), allowing for a standard deviation of 0.3. A final sample size of 10 participants will be recruited to allow for a 10% drop-out rate (based on previous studies).
Analysis of the primary and secondary outcome measures will be done using a paired t-test for the analysis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
29/06/2015
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 3923 0
John Hunter Children's Hospital - New Lambton
Recruitment hospital [2] 3924 0
John Hunter Hospital Royal Newcastle Centre - New Lambton

Funding & Sponsors
Funding source category [1] 291472 0
Charities/Societies/Foundations
Name [1] 291472 0
John Hunter Charitable Trust
Country [1] 291472 0
Australia
Primary sponsor type
Hospital
Name
John Hunter Children's Hospital
Address
John Hunter Hospital
Locked Bag 1, Hunter Region Mail Centre
New Lambton, NSW 2305
Country
Australia
Secondary sponsor category [1] 290150 0
None
Name [1] 290150 0
Address [1] 290150 0
Country [1] 290150 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293020 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 293020 0
Hunter New England Research Ethics & Governance Unit
Locked Bag 1 New Lambton NSW 2305
Ethics committee country [1] 293020 0
Australia
Date submitted for ethics approval [1] 293020 0
Approval date [1] 293020 0
20/04/2015
Ethics approval number [1] 293020 0
15/02/18/4.05

Summary
Brief summary
The research team have developed a novel artificial pancreas algorithm named SCENIC. The SCENIC algorithm has been shown to control insulin delivery and maintain good glycaemic control, including following exercise and food, on a diabetes simulator.
In order to advance this technology, the next stage is to test the algorithm in people with type 1 diabetes. Therefore, this study aims to compare the SCENIC algorithm with standard insulin. Adults and children with type 1 diabetes will be given a meal and either standard insulin or SCENIC controlled insulin and the blood glucose will be monitored for 4 hours after the meal.
To achieve this aim, we will recruit 10 children and adults with type 1 diabetes using insulin pump therapy (a small, programmable device that gives insulin). Participants will attend HMRI on 5 consecutive evenings, during which they will be given a test meal with the insulin dose determined using either standard clinical practice or the SCENIC algorithm. Their blood glucose levels will be monitored for 4 hours following the meal to determine whether the SCENIC algorithm can improve their blood glucose control without causing hypoglycaemia.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 58110 0
A/Prof Bruce King
Address 58110 0
John Hunter Children's Hospital
Locked Bag 1
Hunter Region Mail Centre
New Lambton Heights, NSW, 2305
Country 58110 0
Australia
Phone 58110 0
+61 2 4985 5634
Fax 58110 0
Email 58110 0
[email protected]
Contact person for public queries
Name 58111 0
A/Prof Bruce King
Address 58111 0
John Hunter Children's Hospital
Locked Bag 1
Hunter Region Mail Centre
New Lambton Heights, NSW, 2305
Country 58111 0
Australia
Phone 58111 0
+61 2 4985 5634
Fax 58111 0
Email 58111 0
[email protected]
Contact person for scientific queries
Name 58112 0
A/Prof Bruce King
Address 58112 0
John Hunter Children's Hospital
Locked Bag 1
Hunter Region Mail Centre
New Lambton Heights, NSW, 2305
Country 58112 0
Australia
Phone 58112 0
+61 2 4985 5634
Fax 58112 0
Email 58112 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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