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Trial registered on ANZCTR


Registration number
ACTRN12624000712505p
Ethics application status
Submitted, not yet approved
Date submitted
24/05/2024
Date registered
7/06/2024
Date last updated
7/06/2024
Date data sharing statement initially provided
7/06/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Safety and Effectiveness of the Omnipod 5 SmartAdjust 2.0 System in Individuals with Type 1 and Type 2 Diabetes
Scientific title
Safety and Effectiveness of the Omnipod 5 SmartAdjust 2.0 System in Individuals with Type 1 and Type 2 Diabetes
Secondary ID [1] 312151 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes 333799 0
Type 2 Diabetes 333980 0
Condition category
Condition code
Metabolic and Endocrine 330470 330470 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This single-arm study will enroll up to 75 participants aged 2-70 years with Type 1 diabetes and aged 16-70 years with Type 2 diabetes to initiate the use of the Omnipod 5 SmartAdjust 2.0 (SA 2.0) System. This is an Automated Insulin Delivery (AID) system which requires Continuous Glucose Monitoring (CGM) combined with an insulin pump and an algorithm that adapts insulin delivery in real time to target normal glucose levels. The Omnipod 5 AID System has a novel algorithm with customizable glucose targets and unique configuration utilizing a tubeless insulin pump (Pod), which is a small adhesive patch pump worn on the body. The cannula is automatically deployed directly under the Pod, creating an infusion site without external tubing. The Pod is worn continuously for up to 72 hours. All user interactions are conducted wirelessly through a mobile App on a Smartphone.
The Omnipod 5 System is FDA cleared for patients with Type 1 Diabetes with over 250,000 users on the product. The investigational Omnipod 5 SA2.0 AID System is comprised of the following components: a modified version of the current US commercial Omnipod 5 Pod (Omnipod 5 SA2.0 Pod), and a modified version of the current US commercial Omnipod 5 App on a compatible Smartphone (Omnipod 5 SA2.0 App).
Participants will undergo 2 weeks of Standard Therapy while using a Dexcom G6 CGM in an outpatient setting before proceeding to Period 1. Participants will have a blinded Dexcom G6 placed on body, marking commencement of Standard Therapy. During Standard Therapy, participants will continue to wear the blinded Dexcom G6 and manage their diabetes at home using their current insulin therapy routine.
After the completion of Standard Therapy, participants will receive specific training to use the Omnipod SA2.0 System. The training will be face-to-face, in a single two-hour session, and be provided by a member of the research team. Clinical study staff will go through step-by-step instruction and confirm that participants understand how to use the Omnipod 5 SA2.0 System, including how to change the Pods and administer a bolus.
Period 1: Participants will use the Omnipod 5 SA2.0 System in an outpatient setting for up to 6 weeks. Participants will use U-100 rapid-acting insulin analogs (Humalog U-100, Novorapid) with the Omnipod 5 SA2.0 System. During weeks 1-2, participants will have to manually prompt meal boluses through the Omnipod 5 SA2.0 App. During weeks 3-6, participants will be instructed not to exceed 3 meal boluses/day.
Period 2: At the conclusion of Period 1, participants may transition to the optional extension portion of the study for up to an additional 6 months using the Omnipod 5 SA2.0 System. There will not be any meal bolus restrictions during Period 2, participants may use the Omnipod 5 SA2.0 System freely.
Device analytics will be used to monitor adherence to the intervention.
Intervention code [1] 328587 0
Treatment: Devices
Comparator / control treatment
Comparator is Standard Therapy and participants will act as their own control. Participants who do not have the minimum requirement of CGM data will undergo 2 weeks of Standard Therapy while using Dexcom G6 CGM in an outpatient setting. Participants will continue their usual diabetes treatment regimen during this period. All participants use insulin in their diabetes treatment regimen, which includes insulin pump, basal-bolus, premix and basal only.
Control group
Active

Outcomes
Primary outcome [1] 338242 0
Percentage of time in hypoglycaemic range <3.9 mmol/L (<70 mg/dL)
Timepoint [1] 338242 0
At the end of Period 1 and Period 2 (optional) compared to Standard Therapy
Primary outcome [2] 338243 0
Percentage of time in hyperglycaemic range >13.9 mmol/L (>250 mg/dL)
Timepoint [2] 338243 0
At the end of Period 1 and Period 2 (optional) compared to Standard Therapy
Secondary outcome [1] 435104 0
Per-participant Mean glucose
Timepoint [1] 435104 0
At the end of Period 1 and Period 2 (optional) compared to Standard Therapy
Secondary outcome [2] 435105 0
Per-participant Percentage of time < 3.0 mmol/L (<54 md/dL)
Timepoint [2] 435105 0
At the end of Period 1 and Period 2 (optional) compared to Standard Therapy
Secondary outcome [3] 435106 0
Per-participant Percentage of time > 10.0 mmol/L (>180 mg/dL)
Timepoint [3] 435106 0
At the end of Period 1 and Period 2 (optional) compared to Standard Therapy
Secondary outcome [4] 435107 0
Per-participant Percentage of time > 16.7 mmol/L (>300 mg/dL)
Timepoint [4] 435107 0
At the end of Period 1 and Period 2 (optional) compared to Standard Therapy
Secondary outcome [5] 435108 0
Per-participant Percentage of time between 3.9-10.0 mmol/L (70-180 mg/dL)
Timepoint [5] 435108 0
At the end of Period 1 and Period 2 (optional) compared to Standard Therapy
Secondary outcome [6] 435109 0
Per-participant glycaemic variability (Standard deviation (SD) and coefficient of variation (CV))
Timepoint [6] 435109 0
At the end of Period 1 and Period 2 (optional) compared to Standard Therapy
Secondary outcome [7] 435110 0
Per-participant Average total daily insulin (TDI)
Timepoint [7] 435110 0
At the end of Period 1 and Period 2 (optional) compared to Standard Therapy
Secondary outcome [8] 435111 0
Per-participant Average total daily insulin/kilogram (TDI/kg)
Timepoint [8] 435111 0
At the end of Period 1 and Period 2 (optional) compared to Standard Therapy
Secondary outcome [9] 435112 0
Per-participant incidence rate of severe hypoglycaemia (with cognitive impairment such that assistance of another individual is needed for treatment) (events per person months)
Timepoint [9] 435112 0
At the end of Period 1 and Period 2 (optional) compared to participant reported events (patient recall) over the preceding year prior to the start of Period 1
Secondary outcome [10] 435113 0
Per-participant incidence rate of diabetic ketoacidosis (DKA) (events per person months)
Timepoint [10] 435113 0
At the end of Period 1 and Period 2 (optional) compared to participant reported events (patient recall) over the preceding year prior to the start of Period 1
Secondary outcome [11] 435761 0
Per-participant incidence rate of hyperosmolar hyperglycaemic state (HHS) (events per person months)
Timepoint [11] 435761 0
At the end of Period 1 and Period 2 (optional) compared to participant reported events (patient recall) over the preceding year prior to the start of Period 1

Eligibility
Key inclusion criteria
1. Age at time of consent 2-70 years
2. Diabetes diagnosis, based on Investigator's clinical judgement, and meets the following:
-Type 1 diabetes: 2-70 years old with HbA1c <11%. Diagnosed for at least 6 months for participants aged 2-<7 years or at least 1 year for participants aged 7-70 years.
Or
-Type 2 diabetes: 16-70 years old, diagnosed with T2D and on current insulin regimen for at least 3 months. Includes basal-bolus, pre-mix, or basal only users. For basal-bolus and premix users, must have HbA1c <12%. For basal only users must have HbA1c >=7.0% and <12%.
3. Living with a parent or guardian if < 16 years old
4. Currently using U-100 rapid-acting insulin analogs with insulin pump or basal-bolus, pre-mix, or basal only users suitable for conversion to pump therapy for at least 3 months prior to study start
5. Willing to use only the following types of U-100 insulin during the study: Humalog U-100, Novorapid, or their generic equivalents
6. Deemed appropriate for pump therapy per Investigator’s assessment considering previous history of severe hypoglycemic and hyperglycemic events, and other
comorbidities
7. Stable doses over the preceding 4 weeks of other glucose lowering medications, as determined by Investigator, including within class dose equivalent medication
8. Stable doses over the preceding 4 weeks of weight loss medications that may affect glycemic control directly and/or indirectly, as determined by Investigator
9. Investigator has confidence that the participant and/or caregiver can safely operate all study devices and can adhere to the protocol
10. Willing to wear the system, including Pods, continuously throughout the study
11. If female of childbearing potential, willing and able to have pregnancy testing
Minimum age
2 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Any medical condition, which in the opinion of the Investigator, would put the participant at an unacceptable safety risk
2. Current or known history of coronary artery disease that is not stable with medical management, including unstable angina, or angina that prevents moderate exercise despite medical management, or a history of myocardial infarction, percutaneous coronary intervention, or coronary artery bypass grafting within the 12 months prior to screening
3. Any planned surgery during the study which could be considered major in the opinion of the Investigator
4. Severe retinopathy based on retinal screening performed within the last 24 months
5. History of severe hypoglycemia in the past 6 months. Severe hypoglycemia is defined as an event that requires the assistance of another person due to altered consciousness, and
requires another person to actively administer carbohydrate, glucagon, or other resuscitative actions
6. History of diabetic ketoacidosis (DKA) or hyperosmolar hyperglycemic state (HHS) in the past 6 months, unrelated to an intercurrent illness or infusion failure
7. Unable to tolerate adhesive tape or has any unresolved skin condition in the area of sensor or pump placement
8. Blood disorder or dyscrasia within 3 months prior to screening, including use of hydroxyurea, which in the Investigator’s opinion could interfere with determination of HbA1c
9. Plans to receive blood transfusion over the course of the study
10. Pregnant or lactating, or is a woman of childbearing potential and not on acceptable form of birth control (acceptable forms of contraception include abstinence, barrier methods such as condoms, hormonal contraceptives, intrauterine device, surgical
sterilization such as tubal ligation or hysterectomy, or vasectomized partner)
11. Participation in another clinical study using an investigational drug or device within 30-days or intends to participate in any other study during this study period
12. Unable to follow clinical protocol for the duration of the study or is otherwise deemed unacceptable to participate in the study per the Investigator’s clinical judgment
13. Participant is an employee of Insulet, an Investigator or Investigator’s study team, or immediate family member of any of the aforementioned

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The primary objective of the study is the assessment of safety. Therefore, there are no formal statistical hypotheses associated with any of the endpoints. Outcomes will be primarily descriptive in nature.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2024
Actual
Date of last participant enrolment
Anticipated
31/10/2024
Actual
Date of last data collection
Anticipated
31/07/2025
Actual
Sample size
Target
48
Accrual to date
Final
Recruitment outside Australia
Country [1] 26336 0
New Zealand
State/province [1] 26336 0

Funding & Sponsors
Funding source category [1] 316516 0
Commercial sector/Industry
Name [1] 316516 0
Insulet Corporation
Country [1] 316516 0
United States of America
Primary sponsor type
University
Name
University of Otago, Christchurch.
Address
Country
New Zealand
Secondary sponsor category [1] 318695 0
None
Name [1] 318695 0
Address [1] 318695 0
Country [1] 318695 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 315310 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 315310 0
https://ethics.health.govt.nz/about/central-health-and-disability-ethics-committee/
Ethics committee country [1] 315310 0
New Zealand
Date submitted for ethics approval [1] 315310 0
15/05/2024
Approval date [1] 315310 0
Ethics approval number [1] 315310 0

Summary
Brief summary
This feasibility study is a prospective, single arm study evaluating the Omnipod 5 SmartAdjust 2.0 System in adults and children with type 1 diabetes, and in adults with type 2 diabetes. Participants will undergo 2 weeks of Standard Therapy while using a Dexcom G6 CGM in an outpatient setting before proceeding to Period 1. In Period 1, participants will use the Omnipod 5 SA2.0 System in an outpatient setting for up to 6 weeks. During weeks 3-6, participants will be instructed not to exceed 3 meal boluses/day. At the conclusion of Period 1, participants may transition to the optional extension portion of the study (Period 2), for up to an additional 6 months of unrestricted use of the Omnipod 5 SA2.0 System.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 134294 0
A/Prof Martin de Bock
Address 134294 0
Department of Paediatrics, University of Otago, Terrace House, Level 3, 4 Oxford Terrace, Christchurch 8011
Country 134294 0
New Zealand
Phone 134294 0
+64 3 372 6763
Fax 134294 0
Email 134294 0
martin.debock@otago.ac.nz
Contact person for public queries
Name 134295 0
Martin de Bock
Address 134295 0
Department of Paediatrics, University of Otago, Terrace House, Level 3, 4 Oxford Terrace, Christchurch 8011
Country 134295 0
New Zealand
Phone 134295 0
+64 3 372 6763
Fax 134295 0
Email 134295 0
martin.debock@otago.ac.nz
Contact person for scientific queries
Name 134296 0
Martin de Bock
Address 134296 0
Department of Paediatrics, University of Otago, Terrace House, Level 3, 4 Oxford Terrace, Christchurch 8011
Country 134296 0
New Zealand
Phone 134296 0
+64 3 372 6763
Fax 134296 0
Email 134296 0
martin.debock@otago.ac.nz

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?

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
No additional documents have been identified.