Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000451404
Ethics application status
Approved
Date submitted
30/04/2025
Date registered
13/05/2025
Date last updated
13/05/2025
Date data sharing statement initially provided
13/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Safety and Efficacy of The iLet Bionic Pancreas System (algorithm 2.0), a new automated insulin delivery (AID) system, in people with type 1 diabetes
Scientific title
Safety and Efficacy of a new automated insulin delivery (AID) system in people with type 1 diabetes: The iLet Bionic Pancreas System Alternate Insulin Algorithms Study
Secondary ID [1] 314308 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 diabetes 337255 0
Condition category
Condition code
Metabolic and Endocrine 333659 333659 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Automated insulin delivery (AID) is a new therapy that aims to improve outcomes for people with diabetes. AID links an insulin pump and continuous glucose monitoring (CGM) to a math program (algorithm) that automatically adjusts insulin delivery to try and keep blood glucose levels in a normal range.
The purpose of this study is to test how well a new AID system can safely and effectively control blood glucose.
The iLet Bionic Pancreas (BP) System using the current insulin dosing algorithm 1.0 is commercially available in the USA. The new AID system has modified the iLet BP System to include a new insulin dosing algorithm (2.0). The version 2.0 algorithm is entirely new and uses different underlying principles to achieve a similar user experience. The system is based on the commercially available iLet Bionic Pancreas (BP) System (which uses algorithm 1.0), using an insulin infusion pump containing a new algorithm (2.0), a Dexcom G6 continuous glucose monitor (CGM), and a smartphone with the iLet App installed.
This study consists of a single-arm test-run period or periods for initial qualification of algorithm 2.0, followed by a prospective random-order, two-period crossover trial, assessing outcomes over 4 weeks of using the BP with each of the two insulin dosing algorithms (1.0 and 2.0).
Standard Therapy will involve the collection of baseline CGM data for 14 days. Participants will wear a blinded Dexcom G6 CGM sensor for 14 days. If they are a current CGM user and agree to share their last 14 days of CGM data, they are able to bypass Standard Therapy. Once baseline CGM data have been collected, participants will use the BP system running algorithm 2.0 for 2 weeks to evaluate its safety and performance. After the test-run is completed, the participants will return to their usual diabetes management regimen and the results will be analysed. If the minimum safety and efficacy standards are not met, or if they are met but the analysis of the results indicates changes to the algorithm could improve performance, algorithm 2.0 will be modified and a second test-run period will be performed. Each test-run period will be up to 4 weeks (two weeks of Standard Therapy to collect baseline CGM data followed by two weeks use of the BP system running algorithm 2.0).
During the crossover trial, participants will use the BP for a 4-week period using the 1.0 algorithm and the other 4-week period using the 2.0 algorithm, in random order. During the first 3 weeks of each 4-week study period, participants will be encouraged to use the qualitative meal announcement feature (meals announced as Breakfast, Lunch, or Dinner, and Usual for me, More, or Less). Meals are announced by tapping the Meal Announcement icon at the bottom of the home screen. The meal type is then selected as "Breakfast", "Lunch", or "Dinner". The carbohydrate amount will default to "Usual for me", reflecting the usual amount of carbohydrates typically eaten at that meal. This amount can be changed to "More" or "Less", depending on the carbohydrate content of the meal. During the last week of each 4-week study period, the participant will use the BP in fully closed-loop mode, where they will be asked to continue using the BP without meal announcements. The intervention remains exactly the same when meals are announced and not announced. The study will compare how well each of the two algorithms (1.0 and 2.0) can manage glucose levels following meal announcements and without meal announcements. Participants eat their usual diet throughout the study.
Although this is a random order crossover trial, no 'wash out' period is required between treatments. This is due to the half life of rapid acting insulin being so short that any effect has gone within 4 hours of changing treatments.
Participants will be asked to complete the following self-reported surveys and questionnaires:
Hypoglycaemia survey - every day during the use of the BP in the Test-Run period, and every other day during the use of the BP in the Crossover Trial.
iLet and Algorithm Experience Questionnaire - at the end of the Test-Run period, and after 3-weeks and 4-weeks use of the BP with algorithm 1.0 and algorithm 2.0 during the Crossover Trial.
Diabetes Constraints Scale - at the start and end of using the BP during the Test-Run period, and at the following time points during the Crossover Trial : start of BP use, and after 3-weeks and 4-weeks use of the BP with algorithm 1.0 and algorithm 2.0.
Intervention code [1] 330920 0
Treatment: Devices
Comparator / control treatment
Comparator is 14 days of baseline CGM data collected while using the participants usual method of insulin delivery prior to BP initiation.
Analysis will compare outcomes using the BP with the current algorithm (1.0) and the BP using the alternative algorithm (2.0).
A comparison of both BP algorithms will also be made to baseline CGM data collected during 14 days of the participants' usual therapy prior to enrolment in the study.
Control group
Active

Outcomes
Primary outcome [1] 341252 0
Mean CGM glucose
Timepoint [1] 341252 0
Continuously through from baseline CGM data (2 weeks) compared to 14 days of BP use with algorithm 2.0 (Test-Run period) Continuously through from baseline CGM data (2 weeks) compared to outcomes after 3 and 4 weeks of using the BP with algorithms 1.0 and 2.0 (Crossover Trial). Outcomes using the BP with algorithm 1.0 and 2.0 will also be compared.
Primary outcome [2] 341253 0
Time glucose <3.0 mmol/L
Timepoint [2] 341253 0
Continuously through from baseline CGM data (2 weeks) compared to 14 days of BP use with algorithm 2.0 (Test-Run period) Continuously through from baseline CGM data (2 weeks) compared to outcomes after 3 and 4 weeks of using the BP with algorithms 1.0 and 2.0 (Crossover Trial). Outcomes using the BP with algorithm 1.0 and 2.0 will also be compared.
Primary outcome [3] 341254 0
Severe hypoglycaemia (requiring assistance of another person due to altered consciousness to actively administer carbohydrate, glucagon, or other resuscitative actions).
Timepoint [3] 341254 0
Continuously through from baseline CGM data (14 days) compared to 14 days of BP use with algorithm 2.0 (Test-Run period) Continuously through from baseline CGM data (14 days) compared to outcomes after 3 and 4 weeks of using the BP with algorithms 1.0 and 2.0 (Crossover Trial). Outcomes using the BP with algorithm 1.0 and 2.0 will also be compared.
Secondary outcome [1] 446910 0
Time glucose in range (3.9-10 mmol/L) (TIR)
Timepoint [1] 446910 0
Continuously through from baseline CGM data (14 days) compared to 14 days of BP use with algorithm 2.0 (Test-Run period) Continuously through from baseline CGM data (14 days) compared to outcomes after 3 and 4 weeks of using the BP with algorithms 1.0 and 2.0 (Crossover Trial). Outcomes using the BP with algorithm 1.0 and 2.0 will also be compared.
Secondary outcome [2] 446911 0
CGM metrics (time glucose 10.0 mmol/L and time glucose >13.9 mmol/L)
Timepoint [2] 446911 0
Continuously through from baseline CGM data (14 days) compared to 14 days of BP use with algorithm 2.0 (Test-Run period) Continuously through from baseline CGM data (14 days) compared to outcomes after 3 and 4 weeks of using the BP with algorithms 1.0 and 2.0 (Crossover Trial). Outcomes using the BP with algorithm 1.0 and 2.0 will also be compared.
Secondary outcome [3] 446912 0
Coefficient of variation of glucose values
Timepoint [3] 446912 0
Continuously through from baseline CGM data (14 days) compared to 14 days of BP use with algorithm 2.0 (Test-Run period) Continuously through from baseline CGM data (14 days) compared to outcomes after 3 and 4 weeks of using the BP with algorithms 1.0 and 2.0 (Crossover Trial). Outcomes using the BP with algorithm 1.0 and 2.0 will also be compared.
Secondary outcome [4] 446913 0
Number of meal announcements per day
Timepoint [4] 446913 0
Daily through from baseline CGM data compared to 14 days of BP use with algorithm 2.0 (Test-Run period) Daily through from baseline CGM data compared to outcomes after 3 and 4 weeks of using the BP with algorithms 1.0 and 2.0 (Crossover Trial). Outcomes using the BP with algorithm 1.0 and 2.0 will also be compared.
Secondary outcome [5] 446914 0
Percentage of meals announced as Usual for me, More and Less (for algorithm 1.0).
Timepoint [5] 446914 0
Daily through from baseline CGM data compared to outcomes at week 3 and at week 4 of using the BP with algorithm 1.0 (Crossover Trial). Outcomes using the BP with algorithm 1.0 and 2.0 will also be compared.
Secondary outcome [6] 446915 0
Number of engagements (swipes to unlock) per day
Timepoint [6] 446915 0
Daily through from baseline CGM data compared to 14 days of BP use with algorithm 2.0 (Test-Run period) Daily through from baseline CGM data compared to outcomes after 3 and 4 weeks of using the BP with algorithms 1.0 and 2.0 (Crossover Trial). Outcomes using the BP with algorithm 1.0 and 2.0 will also be compared.
Secondary outcome [7] 446916 0
Insulin total daily dose (u/day and u/kg/day)
Timepoint [7] 446916 0
Daily through from baseline CGM data (14 days) compared to 14 days of BP use with algorithm 2.0 (Test-Run period) Daily through from baseline CGM data (14 days) compared to outcomes after 3 and 4 weeks of using the BP with algorithms 1.0 and 2.0 (Crossover Trial). Outcomes using the BP with algorithm 1.0 and 2.0 will also be compared.
Secondary outcome [8] 446917 0
Percentage of time in Higher, Usual, and Lower target.
Timepoint [8] 446917 0
Continuously through from baseline CGM data compared to 14 days of BP use with algorithm 2.0 (Test-Run period) Continuously through from baseline CGM data compared to outcomes after 3 and 4 weeks of using the BP with algorithms 1.0 and 2.0 (Crossover Trial). Outcomes using the BP with algorithm 1.0 and 2.0 will also be compared.
Secondary outcome [9] 446918 0
Number of meals announced during the period in which participants are asked not to announce meals and use the system in fully closed-loop mode
Timepoint [9] 446918 0
Daily through from baseline CGM data compared to outcomes after 3 weeks use and compared to after 4 weeks of using the BP with algorithms 1.0 and 2.0 (Crossover Trial). Outcomes using the BP with algorithm 1.0 and 2.0 will also be compared.
Secondary outcome [10] 446919 0
Composite secondary outcome: Population-based CGM outcomes (standard deviation in population mean glucose, percentage of participants with: mean glucose <8.6 mmol/L, time glucose <3.0 mmol/L 70%, time glucose <3.9 mmol/L <4%, and mean glucose 8.6 mmol/L and time glucose <3.0 mmol/L <1%.
Timepoint [10] 446919 0
Continuously through from baseline CGM data (14 days) compared to 14 days of BP use with algorithm 2.0 (Test-Run period) Continuously through from baseline CGM data (14 days) compared to outcomes after 3 and 4 weeks of using the BP with algorithms 1.0 and 2.0 (Crossover Trial). Outcomes using the BP with algorithm 1.0 and 2.0 will also be compared.
Secondary outcome [11] 446975 0
Number of times per day (week) participants take carbohydrates to prevent or treat hypoglycaemia Grams of carbohydrate taken per day (week) to prevent or treat hypoglycaemia Patient-ranked rationales for taking carbohydrates to prevent or treat hypoglycaemia
Timepoint [11] 446975 0
Hypoglycaemia survey: daily during use of BP in Test-Run, every other day during use of BP in Crossover Trial
Secondary outcome [12] 447180 0
Additional Primary outcome: Diabetic ketoacidosis (meeting definition in protocol and treatment provided in a healthcare facility)
Timepoint [12] 447180 0
Baseline CGM data (14 days) compared to 14 days of BP use with algorithm 2.0 (Test-Run period) Baseline CGM data (14 days) compared to outcomes after 3 and 4 weeks of using the BP with algorithms 1.0 and 2.0 (Crossover Trial). Outcomes using the BP with algorithm 1.0 and 2.0 will also be compared.
Secondary outcome [13] 447182 0
Percentage of meals announced as 25%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 100%, 110%, 120%, 130%, 140%, 150%, 160%, 170%, 175% (for algorithm 2.0)
Timepoint [13] 447182 0
Continuously through from baseline CGM data compared to 14 days of BP use with algorithm 2.0 (Test-Run period) Continuously through from baseline CGM data compared to outcomes after 3 and 4 weeks of using the BP with algorithms 1.0 and 2.0 (Crossover Trial). Outcomes using the BP with algorithm 1.0 and 2.0 will also be compared.
Secondary outcome [14] 447184 0
Percentage of meals announced as 25-70% of Usual, 80-120% of Usual, and 130-175% of Usual (for algorithm 2.0)
Timepoint [14] 447184 0
Continuously through from baseline CGM data compared to 14 days of BP use with algorithm 2.0 (Test-Run period) Continuously through from baseline CGM data compared to outcomes after 3 and 4 weeks of using the BP with algorithms 1.0 and 2.0 (Crossover Trial). Outcomes using the BP with algorithm 1.0 and 2.0 will also be compared.
Secondary outcome [15] 447186 0
Mean glucose target.
Timepoint [15] 447186 0
Continuously through from baseline CGM data compared to 14 days of BP use with algorithm 2.0 (Test-Run period) Continuously through from baseline CGM data compared to outcomes after 3 and 4 weeks of using the BP with algorithms 1.0 and 2.0 (Crossover Trial). Outcomes using the BP with algorithm 1.0 and 2.0 will also be compared.
Secondary outcome [16] 447228 0
Diabetes Constraints Scale score
Timepoint [16] 447228 0
Diabetes Constraints Scale: at the start and end of BP use in the Test-Run, at the following timepoints in the Crossover Trial - the start of BP use, after 3-weeks and 4-weeks use of the BP with algorithm 1.0 and 2.0.
Secondary outcome [17] 447229 0
Results from the iLet and Algorithm Experience Questionnaire
Timepoint [17] 447229 0
iLet and Algorithm Experience Questionnaire: at the end of BP use in Test-Run, after 3-weeks use and 4-weeks use of the BP using algorithm 1.0 and algorithm 2.0 in the Crossover Trial

Eligibility
Key inclusion criteria
1. Clinical diagnosis of type 1 diabetes for at least one year.
2. Diabetes managed using the same regimen (pump without automation, Hybrid Closed Loop (HCL) pump, or multiple daily injections (MDI)) for at least 3 months prior to enrolment (signing consent form).
3. Age greater than or equal to 6 years old at the time of signing the informed consent/assent.
4. If < 18 years old, living with one or more parent/legal guardian who is knowledgeable about emergency procedures for severe hypoglycaemia.
5. If greater than or equal to 18 years old, participant has a relative or acquaintance who lives within 30-minute travel time of participant and is willing to be contacted to check on participant if study staff feel that participant may be experiencing a medical emergency and can’t be reached.
6. Willing to have their CGM data and iLet data monitored remotely during study participation and to be contacted at any time of the day or night if there is concern regarding their safety based on monitoring of that data.
7. If using a rapid-acting insulin other than lispro (Humalog) or aspart (NovoRapid), willing to switch to one of these for the duration of study participation.
8. Has no plans for travel that would preclude attendance at study visits.
9. Female participants must not be a) pregnant (confirmed by negative urine hCG), b) breastfeeding, or c) planning to become pregnant during the study period and must meet one of the following criteria:
a. Participant is post-menarchal and of childbearing potential and agrees to use one of the accepted methods of contraceptive regimens (including abstinence, barrier methods such as condoms, hormonal contraceptives, intrauterine device, surgical sterilization such as tubal ligation or hysterectomy, or vasectomized partner) throughout the entire duration of the trial from screening until the last study visit.
OR
b. Participant is of non-childbearing potential due to pre-menarchal status, post-menopausal status, or surgical sterilization, as confirmed by the investigator.
Minimum age
6 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Participant and/or legal guardian are unable to speak and read English.
2. Known hemoglobinopathy (sickle cell trait is not an exclusion).
3. Current participation in another diabetes-related clinical trial other than one that is observational.
4. History of cystic fibrosis, pancreatitis, or other pancreatic disease, including pancreatic tumour or insulinoma, or history of complete pancreatectomy.
5. Established history of allergy or severe reaction to adhesive or tape that must be used in the study.
6. Use of a non-insulin glucose-lowering medication within 3 months prior to signing informed consent (except metformin or a GLP-1 agonist) that is not approved for use in T1D.
7. For people greater than or equal to 18 years old, most recent (must be within the last 2 years) estimated glomerular filtration rate (eGFR) <30 ml/min OR currently in renal failure on dialysis. If no eGFR is available for a patient greater than or equal to 18 years old during the last 2 years, one must be obtained to confirm eligibility.
8. Any medical condition, which in the opinion of the investigator would put the participant at an unacceptable risk.

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 concealed - central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
14 days of CGM data collection during which participants use their usual diabetes management regimen (Standard Therapy)
Standard Therapy is followed by a single-arm test-run period or periods to collect safety and efficacy data for algorithm 2.0.
Once minimum safety and efficacy standards have been met for algorithm 2.0, participants will be enrolled in a prospective, random-order, two-period crossover trial, in which all participants will use the BP with each of the two insulin dosing algorithms (1.0 and 2.0), in random order.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/05/2025
Actual
Date of last participant enrolment
Anticipated
20/11/2025
Actual
Date of last data collection
Anticipated
20/05/2026
Actual
Sample size
Target
28
Accrual to date
Final
Recruitment outside Australia
Country [1] 27023 0
New Zealand
State/province [1] 27023 0
Canterbury

Funding & Sponsors
Funding source category [1] 318830 0
Commercial sector/Industry
Name [1] 318830 0
Beta Bionics, Inc.
Country [1] 318830 0
United States of America
Primary sponsor type
University
Name
University of Otago, Christchurch.
Address
Country
New Zealand
Secondary sponsor category [1] 321278 0
None
Name [1] 321278 0
Address [1] 321278 0
Country [1] 321278 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317446 0
Northern A Health and Disability Ethics Committee 
Ethics committee address [1] 317446 0
Ethics committee country [1] 317446 0
New Zealand
Date submitted for ethics approval [1] 317446 0
19/02/2025
Approval date [1] 317446 0
23/04/2025
Ethics approval number [1] 317446 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 141058 0
A/Prof Martin de Bock
Address 141058 0
Department of Paediatrics, University of Otago, Terrace House, Level 3, 4 Oxford Terrace, Christchurch 8011
Country 141058 0
New Zealand
Phone 141058 0
+64 3 372 6763
Fax 141058 0
Email 141058 0
[email protected]
Contact person for public queries
Name 141059 0
Martin de Bock
Address 141059 0
Department of Paediatrics, University of Otago, Terrace House, Level 3, 4 Oxford Terrace, Christchurch 8011
Country 141059 0
New Zealand
Phone 141059 0
+64 3 372 6763
Fax 141059 0
Email 141059 0
[email protected]
Contact person for scientific queries
Name 141060 0
Martin de Bock
Address 141060 0
Department of Paediatrics, University of Otago, Terrace House, Level 3, 4 Oxford Terrace, Christchurch 8011
Country 141060 0
New Zealand
Phone 141060 0
+64 3 372 6763
Fax 141060 0
Email 141060 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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
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