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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06547918




Registration number
NCT06547918
Ethics application status
Date submitted
1/08/2024
Date registered
9/08/2024
Date last updated
9/08/2024

Titles & IDs
Public title
SmartAdjust 2.0 System 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] 0 0
SA2.0 Feasibility (NZ)
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Omnipod 5 SA2.0 System

Experimental: Experimental: Participants with Type 1 and Type 2 diabetes -


Treatment: Devices: Omnipod 5 SA2.0 System
The Omnipod 5 SA2.0 System provides automated insulin delivery based on Continuous Glucose Monitoring (CGM) values.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of time in hypoglycemic range <3.9 mmol/L (<70 mg/dL) (assessed by diabetes type (type 1 and type 2))
Timepoint [1] 0 0
End of Period 1 and Period 2 (optional) compared to Standard Therapy
Primary outcome [2] 0 0
Percentage of time in hyperglycemic range >13.9 mmol/L (>250 mg/dL) (assessed by diabetes type (type 1 and type 2))
Timepoint [2] 0 0
End of Period 1 which is upto 6 weeks and Period 2 which is upto 6 months (optional) compared to Standard Therapy
Secondary outcome [1] 0 0
Mean glucose (assessed by diabetes type (type 1 and type 2))
Timepoint [1] 0 0
End of Period 1 which is upto 6 weeks and Period 2 which is upto 6 months (optional) compared to Standard Therapy
Secondary outcome [2] 0 0
Percentage of time < 3.0 mmol/L (<54 mg/dL) (assessed by diabetes type (type 1 and type 2))
Timepoint [2] 0 0
End of Period 1 which is upto 6 weeks and Period 2 which is upto 6 months (optional) compared to Standard Therapy
Secondary outcome [3] 0 0
Percentage of time > 10.0 mmol/L (>180 mg/dL) (assessed by diabetes type (type 1 and type 2))
Timepoint [3] 0 0
End of Period 1 which is upto 6 weeks and Period 2 which is upto 6 months (optional) compared to Standard Therapy
Secondary outcome [4] 0 0
Percentage of time > 16.7 mmol/L (>300 mg/dL) (assessed by diabetes type (type 1 and type 2))
Timepoint [4] 0 0
End of Period 1 which is upto 6 weeks and Period 2 which is upto 6 months (optional) compared to Standard Therapy
Secondary outcome [5] 0 0
Percentage of time between 3.9-10.0 mmol/L (70-180 mg/dL) (assessed by diabetes type (type 1 and type 2))
Timepoint [5] 0 0
End of Period 1 which is upto 6 weeks and Period 2 which is upto 6 months (optional) compared to Standard Therapy
Secondary outcome [6] 0 0
Standard deviation (assessed by diabetes type (type 1 and type 2))
Timepoint [6] 0 0
End of Period 1 which is upto 6 weeks and Period 2 which is upto 6 months (optional) compared to Standard Therapy
Secondary outcome [7] 0 0
Coefficient of variation (assessed by diabetes type (type 1 and type 2))
Timepoint [7] 0 0
End of Period 1 which is upto 6 weeks and Period 2 which is upto 6 months (optional) compared to Standard Therapy
Secondary outcome [8] 0 0
Average total daily insulin (TDI) (assessed by diabetes type (type 1 and type 2))
Timepoint [8] 0 0
End of Period 1 which is upto 6 weeks and Period 2 which is upto 6 months (optional) compared to Standard Therapy
Secondary outcome [9] 0 0
Average TDI/kg (assessed by diabetes type (type 1 and type 2))
Timepoint [9] 0 0
End of Period 1 which is upto 6 weeks and Period 2 which is upto 6 months (optional) compared to Standard Therapy
Secondary outcome [10] 0 0
Incidence rate of severe hypoglycemia (events per person months) (assessed by diabetes type (type 1 and type 2))
Timepoint [10] 0 0
End of Period 1 upto 6 weeks and Period 2 upto 6 months (optional) compared to participant reported events over the preceding year prior to Visit 4
Secondary outcome [11] 0 0
Incidence rate of diabetic ketoacidosis (DKA) and/or hyperosmolar (assessed by diabetes type (type 1 and type 2)) hyperglycemic state (HHS) (events per person months)
Timepoint [11] 0 0
End of Period 1 which is upto 6 weeks and Period 2 which is upto 6 months (optional) compared to participant reported events over the preceding year prior to Visit 4

Eligibility
Key inclusion criteria
Individuals must meet all the following criteria at screening to be included in the study:

1. Age at time of consent 2-70 years (inclusive)
2. Diabetes diagnosis, based on Investigator's clinical judgement, and meets the following:

* Type 1 Diabetes: 2-70 years old with A1c <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 A1c < 12.0%. For basal only users must have A1c > 7.0% and < 12.0%.
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
Individuals who meet any of the following criteria at screening will be excluded from study participation:

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
Not applicable
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
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/07/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
28/08/2025
Actual
Sample size
Target
75
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Christchurch
Country [2] 0 0
New Zealand
State/province [2] 0 0
Wellington

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Insulet Corporation
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study will evaluate the safety and effectiveness of the Omnipod 5 SmartAdjust 2.0 System in individuals aged 2-70 years with type 1 or type 2 diabetes.
Trial website
https://clinicaltrials.gov/study/NCT06547918
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Trang Ly, MD, PhD
Address 0 0
Country 0 0
Phone 0 0
978-600-7000
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06547918