ANZCTR - Registration

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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Type 1 diabetes

Condition category

Condition code

Metabolic and Endocrine

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]

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]

Time glucose <3.0 mmol/L

Timepoint [1]

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]

Severe hypoglycaemia (requiring assistance of another person due to altered consciousness to actively administer carbohydrate, glucagon, or other resuscitative actions).

Timepoint [2]

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.

Primary outcome [3]

Mean CGM glucose

Timepoint [3]

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.

Secondary outcome [1]

Mean glucose target.

Timepoint [1]

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 [2]

Number of engagements (swipes to unlock) per day

Timepoint [2]

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 [3]

Insulin total daily dose (u/day and u/kg/day)

Timepoint [3]

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 [4]

CGM metrics (time glucose 10.0 mmol/L and time glucose >13.9 mmol/L)

Timepoint [4]

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 [5]

Coefficient of variation of glucose values

Timepoint [5]

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 [6]

Percentage of time in Higher, Usual, and Lower target.

Timepoint [6]

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 [7]

Percentage of meals announced as Usual for me, More and Less (for algorithm 1.0).

Timepoint [7]

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 [8]

Time glucose in range (3.9-10 mmol/L) (TIR)

Timepoint [8]

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 [9]

Number of meal announcements per day

Timepoint [9]

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 [10]

Results from the iLet and Algorithm Experience Questionnaire

Timepoint [10]

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

Secondary outcome [11]

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 [11]

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 [12]

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 [12]

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 [13]

Additional Primary outcome: Diabetic ketoacidosis (meeting definition in protocol and treatment provided in a healthcare facility)

Timepoint [13]

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 [14]

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 [14]

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]

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 [15]

Hypoglycaemia survey: daily during use of BP in Test-Run, every other day during use of BP in Crossover Trial

Secondary outcome [16]

Diabetes Constraints Scale score

Timepoint [16]

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]

Percentage of meals announced as 25-70% of Usual, 80-120% of Usual, and 130-175% of Usual (for algorithm 2.0)

Timepoint [17]

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.

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

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]

New Zealand

State/province [1]

Canterbury

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Beta Bionics, Inc.

Country [1]

United States of America

Primary sponsor type

University

Name

University of Otago, Christchurch.

Country

New Zealand

Secondary sponsor category [1]

None

Name [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Northern A Health and Disability Ethics Committee

Ethics committee address [1]

https://ethics.health.govt.nz/about/northern-a-health-and-disability-ethics-committee/

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

19/02/2025

Approval date [1]

23/04/2025

Ethics approval number [1]

Summary

Brief summary

The objective of this study is to test how well a new automated insulin delivery (AID) system can safely control blood glucose in people with type 1 diabetes.  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.  Participants will use the system for 2 weeks to assess the safety and efficacy of algorithm 2.0 (Test-Run).  Once minimum safety and efficacy standards have been met in the Test-Run, a random-order two-period Crossover Trial will take place, assessing outcomes over 4 weeks of using the BP with each of the two insulin dosing algorithms (1.0 and 2.0).  Outcomes will be compared from using the BP system with algorithm 1.0 and 2.0, both with and without meal announcements.

Trial website

Public notes

Contacts

Principal investigator

Name

A/Prof Martin de Bock

Address

Department of Paediatrics, University of Otago, Terrace House, Level 3, 4 Oxford Terrace, Christchurch 8011

Country

New Zealand

Phone

+64 3 372 6763

Email

[email protected]

Contact person for public queries

Name

Martin de Bock

Address

Department of Paediatrics, University of Otago, Terrace House, Level 3, 4 Oxford Terrace, Christchurch 8011

Country

New Zealand

Phone

+64 3 372 6763

Email

[email protected]

Contact person for scientific queries

Name

Martin de Bock

Address

Department of Paediatrics, University of Otago, Terrace House, Level 3, 4 Oxford Terrace, Christchurch 8011

Country

New Zealand

Phone

+64 3 372 6763

Email

[email protected]

Trial Review

Documents added manually

Documents added automatically