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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT06181721




Registration number
NCT06181721
Ethics application status
Date submitted
14/11/2023
Date registered
26/12/2023
Date last updated
2/04/2024

Titles & IDs
Public title
Evaluating Glucose Control Using a Next Generation Automated Insulin Delivery Algorithm in Patients With Type 1 and Type 2 Diabetes
Scientific title
Evaluating Glucose Control Using a Next Generation Automated Insulin Delivery Algorithm in Patients With Type 1 and Type 2 Diabetes
Secondary ID [1] 0 0
EVOLUTION
Universal Trial Number (UTN)
Trial acronym
Evolution
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 Automated Glucose Control System

Experimental: Group A with Type 1 Diabetes - Participants with Type 1 Diabetes

Experimental: Group B with Type 2 Diabetes - Participants with Type 2 Diabetes


Treatment: Devices: Omnipod 5 Automated Glucose Control System
The Omnipod 5 Automated Glucose Control System will provide automated insulin delivery
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of time in hypoglycemic range (defined as < 3.9 mmol/L (<70 mg/dL))
Timepoint [1] 0 0
At the end of Phase 3 and Phase 4 to compare to baseline values
Primary outcome [2] 0 0
Percentage of time in hyperglycemic range (defined as > 13.9 mmol/L (>250 mg/dL))
Timepoint [2] 0 0
measured during the 9 week study phase
Secondary outcome [1] 0 0
Mean glucose value of all participants
Timepoint [1] 0 0
Measured during the 9 week study phase
Secondary outcome [2] 0 0
Percentage of time < 3.0 mmol/L (<54 mg/dL)
Timepoint [2] 0 0
Measured during the 9 week study phase
Secondary outcome [3] 0 0
Percentage of time > 10.0 mmol/L (>180 mg/dL)
Timepoint [3] 0 0
Measured during the 9 week study phase
Secondary outcome [4] 0 0
Percentage of time > 16.7 mmol/L (>300 mg/dL)
Timepoint [4] 0 0
Measured during the 9 week study phase
Secondary outcome [5] 0 0
Percentage of time between 3.9-10.0 mmol/L (70-180 mg/dL)
Timepoint [5] 0 0
Measured during the 9 week study phase
Secondary outcome [6] 0 0
Standard deviation and coefficient of variation
Timepoint [6] 0 0
Measured during the 9 week study phase
Secondary outcome [7] 0 0
Average total daily insulin (TDI)
Timepoint [7] 0 0
Measured during the 9 week study phase
Secondary outcome [8] 0 0
Average TDI/kg
Timepoint [8] 0 0
Measured during the 9 week study phase
Secondary outcome [9] 0 0
Average number of manual boluses/day
Timepoint [9] 0 0
Measured during the 9 week study phase
Secondary outcome [10] 0 0
Average dose of insulin delivered by manual bolus/day
Timepoint [10] 0 0
Measured during the 9 week study phase
Secondary outcome [11] 0 0
Average number of hypoglycemic treatments when CGM is less than 3.9mmol/L
Timepoint [11] 0 0
Measured during the 9 week study phase

Eligibility
Key inclusion criteria
Inclusion Criteria-

Participants must meet all the following criteria to be included in the study:

1. Age at time of consent 16+ years

2. Individuals must be diagnosed with type 1 diabetes based on investigator's clinical
judgment for at least 1 year. Individuals diagnosed with type 2 diabetes must be on
basal and bolus insulin therapy, with no specified duration.

3. A1C between 7.5-11.0% at screening

4. Currently using U-100 rapid-acting insulin analogs with insulin pump or receiving
multiple daily injections suitable for conversion to pump therapy for at least 3
months prior to study start

5. Willing to use a Dexcom G6 CGM for the duration of the study

6. Willing to use the Omnipod® 5 Automated Insulin Delivery System during the study

7. Willing to perform all fingerstick BG testing with their personal blood glucose meter
at the frequency specified in the study protocol or per investigator discretion

8. Willing to participate in at least 45 minutes of exercise and meal challenges during
the 3 day hotel stay (Group A only)

9. Willing to use carbohydrate counting for determination of meal boluses

10. Willing and able to sign the Informed Consent Form (ICF) and/or has a parent/guardian
willing and able to sign the ICF.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants who meet any of the following criteria will be excluded from the study:

1. Any medical condition, such as untreated malignancy, unstable cardiac disease,
unstable or end-stage renal failure, eating disorders, or other conditions which in
the opinion of the investigator, would put the participant at an unacceptable safety
risk

2. Blood disorder or dyscrasia within 3 months prior to screening, including the use of
hydroxyurea, which in the investigator's opinion could interfere with determination of
HbA1C.

3. History of severe hypoglycemia within the past 6 months

4. History of diabetic ketoacidosis or hyperglycemic hyperosmolar syndrome in the past 6
months, unrelated to an intercurrent illness or infusion set failure

5. History of moderate to severe preproliferative or proliferative retinopathy based on
screening within the last 12 months.

6. Planning to start a non-insulin anti-diabetic medication during the study. If on
non-insulin medication, dose must be stable in the previous 30 days.

7. Planning to start a weight-loss agent during the study. If on a weight-loss
medication, dose must be stable in the previous 30 days.

8. Currently on a low carbohydrate diet of < 60 grams of carbohydrates per day

9. Pregnant, 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 sterilisation such as
tubal ligation or hysterectomy, or vasectomised partner)

10. Dermatological conditions at the proposed sensor/pump wear sites that in the
investigator's opinion could preclude ability to wear the Pod and/or the Dexcom sensor

11. 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 previous 12
months.

12. Currently on systemic steroids or intends to receive systemic steroid treatment in the
next 6 months, including stable treatment for adrenal insufficiency. Inhaled,
ophthalmic, topical, joint injection, and other locally applied steroids are allowed.

13. Currently participating in another clinical study using an investigational drug or
device

14. Recent (within the preceding 30 days) participation in a clinical study using an
investigational drug

15. Unable to follow the clinical protocol for the duration of the study or is otherwise
deemed unacceptable to participate in the study per the investigator's clinical
judgment

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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/09/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/01/2024
Sample size
Target
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Christchurch

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

Ethics approval
Ethics application status

Summary
Brief summary
To assess the safety and effectiveness of a next-generation automated insulin delivery
algorithm in participants aged 16+ years with type 1 or type 2 diabetes.
Trial website
https://clinicaltrials.gov/ct2/show/NCT06181721
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries