Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000753459
Ethics application status
Approved
Date submitted
1/06/2016
Date registered
8/06/2016
Date last updated
8/04/2021
Date data sharing statement initially provided
8/04/2021
Date results information initially provided
8/04/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of Hybrid Closed Loop insulin delivery on glucose control in patients with type 1 diabetes aged 12 - 25 years.
Scientific title
The effect of Hybrid Closed Loop Outpatient insulin delivery on time spent in target glucose range in patients with type 1 diabetes aged 12 -25 years.
Secondary ID [1] 289352 0
Nil
Universal Trial Number (UTN)
.U1111-1183-7153
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes 298982 0
Condition category
Condition code
Metabolic and Endocrine 299047 299047 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
MiniMed (Trademark) 670G Insulin Pump Hybrid Closed Loop System.

This system consists on an insulin pump (Medtronic 670G), a continuous glucose monitoring system (3rd generation Enlite sensor), and an algorithm within the insulin pump that calculates background (basal) insulin delivery according to changes in the sensor glucose value. The insulin pump and continuous glucose monitor communicate wirelessly.
.The pump is small enough to fit in the palm of a hand, and is usually carried clipped to a belt. The pump is water resistant and is built to last 4 years. The hybrid closed-loop control algorithm is inbuilt into the insulin pump hardware.
The glucose sensor is the size of a 20 cent coin and clips on to the subcutaneously inserted glucose sensor. The sensor has an "inserter" and participants will be trained to insert the sensors themselves by a diabetes educator.
The insulin pump and glucose sensor transmitter communicate wirelessly, with a range of approximately 6 meters.

Participants who are randomised to the hybrid closed loop system will be trained by a diabetes nurse educator.

During the run-in phase all participants will receive education sessions on continuous glucose monitoring, and for those randomised to the hybrid closed loop system will have additional training. The following is an outline of the visit history during the run-in phase which also describes the duration and frequency of sessions, and also the post randomisation training required for those participants who go on to the intervention.

Visit 1: Screening and Consent (4 hours)

1. Confirm participant is able to take part in the study.
2. sign a consent form.
3. Collect baseline data including height, weight and current diabetes
treatment.
4. Ask the participant to complete some questionnaires about diabetes.
5. Collect a blood sample

Visit 2: Run in and Education Planning (2 – 8 hrs)
This visit is to plan individual education programs to review carbohydrate counting and teach those that don’t know how to do this.
1. Participants currently on pump therapy will see a dietician (1-2 hrs) to review carbohydrate counting and a diabetes educator to assess pump download capability and review settings
2. Participants on injections will have between 1 – 3 sessions with a dietician to teach carb counting if required (which may be extended over 3 weeks if required). Participants on injections will get an individually programmed Aviva Expert glucometer to help with carbohydrate counting. Participants will not be able to continue with the rest of the study until this is learned.


Visit 3: Sensor Insertion and Training (4 hours)
All participants will be asked to come in the Research clinic to be fitted with a blinded sensor
1. We will teach the participant how to insert a sensor and give you a Contour Next
glucometer (to use in addition to your usual glucometer) to record
BGLs at least 4 times a day
2. We will also give a logbook and ask participants to record signs and
treatment of a hypo, time off work/school and insulin dosing (MDI
patients)

Visits 4 and 5: Sensor Download (30 mins each)
These visits will occur at 7 and 14 days after visit 3 to:
1. Download the sensor and glucometer data
2. Change the sensor and transmitter
3. Check that the log book is up to date

Visit 4 and 5 may be able to happen at the participant location.

Visit 6: Sensor Download and Randomization (4 hours)
At this visit we will:
1. Check that sensor data is complete (if not participant will be offered a further 2 weeks of CGM collection to stay in the study)
2. Collect diabetes clinical data as in Visit 1
3. Collect logbook data
4. Participants will then be randomized to either stay on usual treatment (Control Group), or to the hybrid closed loop system (Intervention Group).


Visit 7: Entry into Study Arm (1 hour)
The schedule for this visit will depend on randomization and baseline therapy:

(i) Control Group
1. Both injections and pump participants will be issued with a new
logbook


(ii) Intervention Group
1. Injections to HCL: Participant to come in for the following visits to teach how to operate the pump, insert sensors and use the hybrid closed loop function (HCL):
Visit 7A: (4 hours) Initial Minimed 670G insulin pump training with a diabetes educator
Visit 7B: Return to the clinic within 3 days to observe insulin line change if required. We will contact participant by phone/email as often as required to see how they are managing and ask them to upload your pump every week
Visit 7C: (2 hours) 2 weeks after starting on the pump we will ask the participant to come in to the research clinic for sensor training. This will include inserting and changing the sensor and setting alarms. We will provide the participant with a sensor user guide and enough sensors for the duration of the study
Visit 7D: (1-2 hours) This session will occur a minimum of 3 days after sensor training and will focus on learning how to initiate and operate the hybrid closed loop function. There will also be the opportunity to practice sensor change. When starting closed loop we will ask the participant to avoid excessive exercise for 48 hours. We will issue a new logbook to include documenting problems with the pump and sensors. We will continue to contact the participant by phone/email each week (or more often if required) over the next 4 weeks and ask the participant to upload the pump weekly

Pump to HCL: We will ask the participant to come in to the clinic for the following visits to teach them how to operate the pump, insert sensors and use the closed loop function:
Visit 7A: (1 – 4 hours) This session is to provide sensor and Minimed 670G pump training. This will include linking the sensor to the pump. We will provide them with a sensor user guide and enough sensors for the duration of the study
Visit 7B: (1 – 2 hours) Following 3 – 7 days of using the sensor collection we will ask the participant to return to the clinic to change the sensor and show them how to start closed loop. This visit will be the same as Visit 7D (see above)

Visit 8 (1 - 2 hours) face to face review (all participants), 4 weeks post randomisation

Visits 9,10: (30 mins each). At week 11 and 12 post randomisation to collect blinded CGM

Visit 11 (approx 4 hours). Mid point of study 13 weeks post randomisation. Repeat collection of auxological data, clinic data, and psychology questionnaires

Visit 12,13, 14 (30 mins each), a week apart starting from week 23 post randomisation. To collected final blinded CGM.

Visit 15 (4 hours), final study visit to complete biomarkers, clinical, auxological and psychology measures.


The overall intervention period is 7 months (one month run in, and 6 months post randomisation).

Adherence will be monitored by a data monitoring service at the NHMRC clinical trials centre. This will be done by examining the hybrid closed loop system pump download data - which includes and adherence report. All data is intention to treat analysis, so participants will be under no pressure to continue the intervention if they wish to withdraw
Intervention code [1] 294929 0
Treatment: Devices
Comparator / control treatment
Standard therapy: Multiple daily injections (MDI)at least 4 injections per day (at least rapid-acting insulin and 1 long-acting insulin), or insulin pump therapy (CSII) established for at least 3months, with or without CGM
Control group
Active

Outcomes
Primary outcome [1] 298510 0
The % time sensor glucose is in target range (3.9–10 mmol/L) during HCL insulin delivery vs standard therapy (MDI and CSII).

This outcome will be measured with a continuous glucose monitor, that is uploaded onto Medtronic software.
Timepoint [1] 298510 0
Measured for 3 weeks; 23-26 weeks post-randomisation.
Secondary outcome [1] 324417 0
Glycaemic (All CGM data as per i) a - i, below will be analysed over 24hrs, daytime hours (0600 – 2400), and night time hours (0000 – 0600))


A sub analysis of Hybrid closed loop (HCL) vs. Multiple daily injection (MDI) and HCL vs. insulin pump therapy (CSII) is planned.

i. CGM data:

This outcome will be measured with a continuous glucose monitor, that is uploaded onto Medtronic software.

a. % CGM Time <2.8 mmol/L
b. % CGM Time <3.3 mmol/L
c. % CGM Time <3.9 mmol/L
d. % CGM Time 3.9-7.8 mmol/L
e. % CGM Time >10.0 mmol/L
f. % CGM Time >13.9 mmol/L
g. % CGM Time >16.7 mmol/L
h. Standard Deviation and Coefficient of Variation of CGM values
i. Mean CGM glucose
Timepoint [1] 324417 0
Continuous glucose monitoring (CGM) data will be collected in three time blocks; baseline (3 weeks CGM), 13 weeks (2 weeks CGM) and 26 weeks (3 weeks CGM) post randomisation.
Secondary outcome [2] 324418 0
Psychosocial:

i. Fear of hypoglycaemia: Hypoglycaemic Fear Survey-II Worry scale: 17- less than 25years. Children’s Hypoglycaemia Fear survey 12 – 17 years.
ii. Hypoglycaemia Awareness: Hypoglycaemia Awareness Scale (Gold Score) (all ages)
iii. Anxiety: State-Trait Anxiety Inventory (Child version for 12-15yrs, adult version =16-<25yrs)
iv. Impact and Satisfaction: The Diabetes Treatment Satisfaction Questionnaire status and change version (16 - less than 25years)
v. Quality of Life:12-less than 25years: EQ-5D-Y,
vi. Diabetes specific quality of life: PedsQL –Child version (12 year olds), Adolescent version (13 – 18) and young adult version (18 – less than 25).
vii. Diabetes distress: Problem Areas in Diabetes (Teen version for 12 – 17 years, standard version =17-less than 25yr)
viii. Impaired awareness of hypoglycaemia: GOLD SCORE, all ages.
ix. Semi structure interview (all ages)
Timepoint [2] 324418 0
Questionnaires will be conducted on 3 occasions: at baseline screening , and 13 weeks and 26 weeks post randomisation
Secondary outcome [3] 324419 0
. Human-technology interaction:

To assess participant technology interaction and explore adherence patterns and approaches that may improve it. Repeated sampling methodology will be used. Ten questions will be asked once a week via a phone app, which will take less than 1 minute to complete. The phone app is currently under development, and is specifically designed for this study. It is not named as yet.
Timepoint [3] 324419 0
Continuous measurement - once a week, for 26 weeks post randomisation.
Secondary outcome [4] 324420 0
Health-economic To assess the health economic impact of the MiniMed trademark 670G Insulin Pump Hybrid Closed Loop System vs standard therapy (MDI and CSII). The following data points will be used as part of the economic analysis: i. QALYs calculated from the EQ-5D ii. Hypoglycaemic events and HbA1c iii. Participant reporting on work interruption iv. Investigator reporting time spent on training, education and support, by the type of health professional resource used v. Diabetes management consumables (glucose strips, ketone strips, batteries, sensors, site dressings, lancets, needles, insulin).
Timepoint [4] 324420 0
End of study - 26 weeks - incorporating the measures above
Secondary outcome [5] 324421 0
Biomarkers (all ages)

To assess the impact of the MiniMe trademark 670G Insulin Pump Hybrid Closed Loop System Vs standard therapy (MDI and CSII) on the biomarkers listed below.
i. Cell Adhesion Molecules (CAM)S
ii. Soluble vascular cell adhesion molecules sVCAM
iii. Soluble intercellular adhesion molecules sICAM
iv. s-e Selectin
v. Oxidized Low density lipoprotein
vi. Myeloperoxidase.
vii. MicroRNA signatures for arterial, renal and retinal complications
viii. Telomerase
ix. DNA methylation/acetylation
x. Glycomark
xi. Isoprostanes and proteomics
xii. Clotting profile
Timepoint [5] 324421 0
Biomarkers will be tested from blood and urine samples at baseline, and 26 weeks post randomisation
Secondary outcome [6] 324422 0
HCL Performance Parameters

To assess the performance of the MiniMed trademark 670G Insulin Pump Hybrid Closed Loop System, and components. The following measures will be used:

i. Proportion of time hybrid closed loop is active - assessed from pump upload
ii. Unplanned exits from closed loop (n) - assessed from pump upload
iii. Sensor performance – mean absolute relative difference (MARD), sensor failures (n) - assessed by comparing continuous glucose monitor sensor readings to capillary blood glucose samples - data collected from the pump upload.
iv. Insulin delivery line performance – reported delivery line failures (n) - assessed from participant report in the issued logbook
Timepoint [6] 324422 0
Continuous data over the 26 weeks from randomisation
Secondary outcome [7] 324485 0
Average Fasting blood glucose (mmol/L),
Timepoint [7] 324485 0
As measured during the three CGM time blocks at baseline, 13 weeks and 26 weeks. Defined as fasting capillary blood glucose level on waking (between 5am and 9am), at least 6 hrs after an insulin bolus for carbohydrate.
Secondary outcome [8] 324486 0
Average Glycaemic control
Timepoint [8] 324486 0
Measured by HbA1c collected at baseline, 13 weeks and 26 weeks post randomisation.
Secondary outcome [9] 324487 0
Hospitalisations rate for diabetic ketoacidosis
Timepoint [9] 324487 0
Assessed continuously over the 7 month study period by patient report in an issued logbook
Secondary outcome [10] 324488 0
Episodes of severe hypoglycaemia
Timepoint [10] 324488 0
Assessed continuously over the 7 month study period ( coma +/- convulsions and may require parenteral therapy (glucagon or i.v.glucose). This will be assessed by patient report in an issued logbook.

Eligibility
Key inclusion criteria
1. Type 1 diabetes (diagnosis consistent with American Diabetes Association Classification of Diabetes Mellitus) diagnosed at least 1 year ago
2. Fasting C peptide less than 0.1nmol/L (in the absence of hypoglycaemia)
3. Insulin regimen either: Multiple daily injections (MDI) more than 4 injections per day (greater than 3 rapid-acting insulin and 1 long-acting insulin), or insulin pump therapy (CSII) established for greater than 3months.
4. Aged 12- less than 25years
5. HbA1c less than 10.5%
6. Living in an area with internet and cellular phone coverage
7. English speaking
Minimum age
12 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Chronic kidney disease (eGFR <45mL/min/1.73m2)
2. Use of any non-insulin glucose-lowering agent within the past 3 months
3 Oral or injected steroid use within the past 3 months
4. Pregnancy, or planned pregnancy within study period
5. Uncontrolled coeliac disease (not following a gluten free diet), or other untreated malabsorption
6 Uncontrolled thyroid disease
7. Clinically-significant gastroparesis
8. Uncontrolled hypertension (DBP >100 mmHg and/or SBP >160 mmHg)
9. History of myocardial infarction, severe uncontrolled heart failure, unstable angina, transient ischaemic attack (TIA), stroke, or thromboembolic disease in the past 3 months.
10. Poor visual acuity precluding use of the investigational technology
11 Inability or unwillingness to meet protocol requirements (including carbohydrate-counting, CGM use as per allocated study group only).
12. Severe or unstable medical or psychological condition which, in the opinion of the investigator, would compromise the ability to meet protocol requirements

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)
Randomization will be stratified based on 4 variables: Time spent in target sensor glucose range (3.9 – 10mmol/L) – with participants evenly split above and below 55% time in target range, age, diabetes duration, and centre site.

Minimisation of variation in gender, age, diabetes duration, and centre site will be undertaken at randomization (baseline visit 2). Minimisation is a method of ensuring excellent balance between groups for known prognostic factors. It is a method of dynamic or adaptive randomization, in which the allocation of the next participant into the trial depends on the characteristics and allocation of participants already randomized. The algorithm works by minimizing the imbalance across multiple factors during each participant allocation. This will be performed using appropriate software, for example MinimPy.
http://sourceforge.net/projects/minimpy.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis
All statistical analyses will be performed using SAS for Windows, version 9.3 (SAS Institute Inc) and STATA version 11.2 (StataCorp). The analysis population will be the intention-to-treat population, which will be defined as all participants who are randomised and have at least 1 visit after baseline. P-values <.05 will be considered statistically significant and 2-sided P-values will be reported. Descriptive statistics will be used to characterize participants at study entry


The primary objective, average % time spent in target glycaemic range (sensor glucose level 3.9 - 10 mmol/l) during 6 months, will be analysed using Analysis of covariance (ANCOVA) adjusting for baseline percentage score and site. Least square means and least square mean differences and their associated 95% confidence intervals will be presented for each treatment group and between groups. In the event that data are not normally distributed the Mann–Whitney–Wilcoxon (Wilcoxon Rank-Sum) Test will be employed which tests the medians. In addition if data are skewed, bootstrap methods will be used which allows for a non-parametric test of the arithmetic means. Bootstrap methods simply estimate the distribution of the statistic through resampling with replacement (many times) from the original data population. These methods will also be employed for average % CGM as outlined in the secondary objectives.

Coefficient of variation will be reported for each group: bootstrap methods will be used to estimate variability as appropriate

Rates of hospitalisations for severe hypoglycaemia and moderate hypoglycaemia as per participant log will be analysed as unadjusted incidence rates based on the Poisson distribution. Incidence rates and incidence rate differences will be presented with their associated 95%confidence intervals calculated as exact Poisson confidence limits. In addition, where appropriate Poisson or negative binomial regression models will be fitted e.g. moderate hypoglycaemia events from the participant log. If there are a high proportion of zero counts, zero inflated Poisson (ZIP) or zero inflated negative binomial models (ZINB) will be considered. If counts are sparse then rates will be reported descriptively only. Number of hospitalisations due to diabetic ketoacidosis events and other safety outcomes will be tabulated and presented as n and %.

Continuous outcome measures (including psychosocial) collected at baseline and endpoint will be analysed using ANCOVA adjusting for baseline score and site. Measures collected at baseline, 3 months and endpoint (e.g. HbA1c, Fasting blood glucose , Mean CGM glucose, Hypoglycaemic Fear Survey-II Worry scale, Child State-Trait Anxiety Inventory, The Diabetes Treatment Satisfaction Questionnaire status and change version , Problem Areas in Diabetes, Impaired awareness of hypoglycaemia: GOLD SCORE) will be analysed using mixed models repeated measures (MMRM) adjusting for baseline score (where appropriate), group, period (baseline, 3 months, 6 months) and site. A random term for ‘individual’ will also be employed if deemed appropriate. Least square means and least square mean differences and their associated 95% confidence intervals will be presented for each group and between groups. Unstructured covariance matrix will be used unless other covariance structures are more appropriate as determined by the Bayesian information criteria (BIC). Human technology interaction analysis will be reported Exploratory; descriptive analysis.

A separate economic analysis will be conducted. using measures (e.g. QALYs calculated from the EQ-5D) collected during the trial.

Performance Parameters will be reported descriptively (n, % for categorical measures and n, mean, median, standard deviation, minimum and maximum for continuous measures)

Sample Size Calculations:

Sample size is computed for a parallel design RCT with 2 groups comparing a hybrid closed-loop system with usual care in individuals with type 1 diabetes with HbA1c <10.5%; with time in range 3.9 – 10mmol/L at 6 months as primary outcome. Sample size is computed for a paediatric study age 12-<25 years old.
To estimate the total sample size, data from the JDRF CGM RCT were used.. There were N=97 12-<25 years of age, who used injections or pumps at enrolment, had a baseline HbA1c value <10.5%, were randomized to the control group (usual care), and had blinded CGM data at randomization and at 6 months. The confidence interval for the effective SD (after adjusting for baseline) was 15% for the younger group.
Assuming parallel groups, normal distribution for the treatment effect, a 1:1 allocation, a 2-tailed test with null hypothesis stating that the difference is zero, no corrections for multiple comparisons, and a type I error = 5%, the following total sample size is required:

To detect a 10% difference, using an SD of 13%, and 85% power, 64 subjects are required in each arm. Allowing for 20% predicted drop-out, 80 subjects will be enrolled to each arm (160 total participants).

This study is also powered to detect a difference in time spent in the hypoglycaemic range (<3.9mmol/L) using the same JDRF CGM RCT data. Since time below 3.9mmol/L at 6 months is not normally distributed, its mean was estimated using a robust procedure. On the other hand, since differences in time below 3.9mmol/L from randomization to 6 months are normally distributed, the SD and the effective SD were estimated using the raw/untransformed data.
The two point estimate and 95% CI confidence intervals for the effective SD 6% (95% CI: 5% to 7%). The estimated robust (MM estimate that down-weights outliers means for % time below 3.9mmol/L at 6 months is 5.7%.
The required total sample size (assuming parallel groups, normal distribution for the change in treatment effect, a 1:1 allocation, a 2-tailed test with null hypothesis stating that the difference is zero, no corrections for multiple comparisons, and a type I error = 5%) is:

12-<25 years: 100 participants required to detect a 60% reduction in time spent <3.9mmol/L (using a 6%SD and 80% power). This is less than the 160 recruitment target to demonstrate an improved time spent in range.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/03/2017
Actual
1/06/2017
Date of last participant enrolment
Anticipated
20/09/2018
Actual
31/10/2019
Date of last data collection
Anticipated
20/10/2018
Actual
31/03/2020
Sample size
Target
160
Accrual to date
Final
133
Recruitment in Australia
Recruitment state(s)
NSW,SA,WA,VIC
Recruitment hospital [1] 5881 0
Princess Margaret Hospital - Subiaco
Recruitment hospital [2] 5882 0
Womens and Childrens Hospital - North Adelaide
Recruitment hospital [3] 5883 0
The Royal Childrens Hospital - Parkville
Recruitment hospital [4] 5884 0
John Hunter Children's Hospital - New Lambton
Recruitment hospital [5] 5885 0
The Children's Hospital at Westmead - Westmead
Recruitment hospital [6] 19075 0
Perth Children's Hospital - Nedlands
Recruitment postcode(s) [1] 13354 0
2145 - Westmead
Recruitment postcode(s) [2] 13353 0
2305 - New Lambton
Recruitment postcode(s) [3] 13330 0
3052 - Melbourne University
Recruitment postcode(s) [4] 13329 0
5006 - North Adelaide
Recruitment postcode(s) [5] 13328 0
6008 - Subiaco
Recruitment postcode(s) [6] 33625 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 293733 0
Government body
Name [1] 293733 0
National Health and Medical Research Council
Country [1] 293733 0
Australia
Funding source category [2] 293734 0
Charities/Societies/Foundations
Name [2] 293734 0
Juvenile Diabetes Research Foundation
Country [2] 293734 0
Australia
Funding source category [3] 293735 0
Commercial sector/Industry
Name [3] 293735 0
Medtronic
Country [3] 293735 0
United States of America
Primary sponsor type
Other
Name
Telethon Kids Institute
Address
Telethon Kids Institute
Perth Children's Hospital
Northern Entrance
15 Hospital Avenue
Nedlands WA 6009
Country
Australia
Secondary sponsor category [1] 292564 0
University
Name [1] 292564 0
National Health and Medical Research Council Clinical Trials Centre, University of Sydney
Address [1] 292564 0
NHMRC Clinical Trials Centre, University of Sydney
Locked Bag 77
Camperdown NSW 1450
Country [1] 292564 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295165 0
Princess Margaret Hospital Ethics Committee
Ethics committee address [1] 295165 0
1 Roberts Road
Subiaco
Western Australia
6008
Ethics committee country [1] 295165 0
Australia
Date submitted for ethics approval [1] 295165 0
07/06/2016
Approval date [1] 295165 0
02/08/2016
Ethics approval number [1] 295165 0
2016087EP
Ethics committee name [2] 308277 0
Women's and Children's Hospital Network HREC
Ethics committee address [2] 308277 0
Women's & Children's Hospital
Level 2, Samuel Way Building
72 King William Road
SA 5006
Ethics committee country [2] 308277 0
Australia
Date submitted for ethics approval [2] 308277 0
26/08/2016
Approval date [2] 308277 0
16/11/2016
Ethics approval number [2] 308277 0
HREC/16/WCHN/100
Ethics committee name [3] 308278 0
Child and Adolescent Health Service HREC
Ethics committee address [3] 308278 0
Perth Children's Hospital
15 Hospital Avenue
Nedlands WA 6009
Ethics committee country [3] 308278 0
Australia
Date submitted for ethics approval [3] 308278 0
25/06/2019
Approval date [3] 308278 0
09/08/2019
Ethics approval number [3] 308278 0
RGS0000002555

Summary
Brief summary
BACKGROUND: Hybrid closed-loop (HCL) insulin delivery, with automatic glucose sensing and insulin delivery reducing patient intervention, offers the potential to improve glycaemic control compared to conventional therapy in patients with type 1 diabetes. Superior glucose control has been demonstrated with lower rates of hypoglycaemia in many in-clinic studies, diabetes camp studies, hotel studies, and now in the first emerging short term outpatient studies using HCL systems.
The primary rationale is to assess glycaemic control with the use of the HCL system versus standard therapy (either injections or standard pump therapy), including time in target range, as well as glycaemic excursions either hypoglycaemia or hyperglycaemia. We will explore the impact of this system on fear of hypoglycaemia and quality of life and other psychological measures. We seek to quantify the economic impact of HCL compared to standard therapy for translational purposes.

AIM: To compare the proportion of time spent in target glycaemic range (sensor glucose level 3.9 - 10 mmol/l) while using HCL or using standard therapy (MDI and CSII).

METHOD: Multi-centre randomized controlled trial in 160 patients aged 12 – 25 years with type 1 diabetes, comparing HCL with standard therapy (MDI or CSII) for 6 months.

OUTCOMES: The primary outcome is the difference in the proportion of time the sensor glucose level is in target range (3.9–10 mmol/L) during HCL insulin delivery vs standard therapy (MDI and CSII), measured 23-26 weeks post-randomisation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 66366 0
Prof Timothy Jones
Address 66366 0
Department of Endocrinology & Diabetes
Perth Children's Hospital
15 Hospital Avenue
Nedlands WA 6009
Country 66366 0
Australia
Phone 66366 0
+61 8 6456 5033
Fax 66366 0
Email 66366 0
Tim.Jones@health.wa.gov.au
Contact person for public queries
Name 66367 0
Prof Timothy Jones
Address 66367 0
Department of Endocrinology & Diabetes
Perth Children's Hospital
15 Hospital Avenue
Nedlands WA 6009
Country 66367 0
Australia
Phone 66367 0
+61 8 64565033
Fax 66367 0
Email 66367 0
Tim.Jones@health.wa.gov.au
Contact person for scientific queries
Name 66368 0
Prof Timothy Jones
Address 66368 0
Department of Endocrinology & Diabetes
Perth Children's Hospital
15 Hospital Avenue
Nedlands WA 6009
Country 66368 0
Australia
Phone 66368 0
+61 8 64565033
Fax 66368 0
Email 66368 0
Tim.Jones@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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
11309Study protocol    370827-(Uploaded-19-06-2020-16-42-12)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEffect of a Hybrid Closed-Loop System on Glycemic and Psychosocial Outcomes in Children and Adolescents with Type 1 Diabetes: A Randomized Clinical Trial.2021https://dx.doi.org/10.1001/jamapediatrics.2021.3965
EmbaseImpact of Missing Data on the Accuracy of Glucose Metrics from Continuous Glucose Monitoring Assessed Over a 2-Week Period.2023https://dx.doi.org/10.1089/dia.2022.0101
EmbaseEffect of 6 months hybrid closed-loop insulin delivery in young people with type 1 diabetes: A randomised controlled trial protocol.2018https://dx.doi.org/10.1136/bmjopen-2017-020275
N.B. These documents automatically identified may not have been verified by the study sponsor.