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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
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Scientific title
Evaluating Glucose Control Using a Next Generation Automated Insulin Delivery Algorithm in Patients With Type 1 and Type 2 Diabetes
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Secondary ID [1]
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EVOLUTION
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Universal Trial Number (UTN)
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Trial acronym
Evolution
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus
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Condition category
Condition code
Metabolic and Endocrine
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Diabetes
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of time in hypoglycemic range (defined as < 3.9 mmol/L (<70 mg/dL))
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Assessment method [1]
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Glucose metric from CGM
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Timepoint [1]
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At the end of Phase 3 and Phase 4 to compare to baseline values
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Primary outcome [2]
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Percentage of time in hyperglycemic range (defined as > 13.9 mmol/L (>250 mg/dL))
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Assessment method [2]
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Glucose metric from CGM
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Timepoint [2]
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measured during the 9 week study phase
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Secondary outcome [1]
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Mean glucose value of all participants
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Assessment method [1]
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Glucose metric from study provided continuous glucose monitor (CGM)
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Timepoint [1]
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Measured during the 9 week study phase
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Secondary outcome [2]
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Percentage of time < 3.0 mmol/L (<54 mg/dL)
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Assessment method [2]
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Glucose metric from CGM
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Timepoint [2]
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Measured during the 9 week study phase
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Secondary outcome [3]
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Percentage of time > 10.0 mmol/L (>180 mg/dL)
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Assessment method [3]
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Glucose metric from CGM
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Timepoint [3]
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Measured during the 9 week study phase
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Secondary outcome [4]
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Percentage of time > 16.7 mmol/L (>300 mg/dL)
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Assessment method [4]
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Glucose metric from CGM
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Timepoint [4]
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Measured during the 9 week study phase
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Secondary outcome [5]
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Percentage of time between 3.9-10.0 mmol/L (70-180 mg/dL)
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Assessment method [5]
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Glucose metric from CGM
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Timepoint [5]
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Measured during the 9 week study phase
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Secondary outcome [6]
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Standard deviation and coefficient of variation
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Assessment method [6]
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Glucose metric from CGM measured glucose variability with the coefficient of variation (CV)
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Timepoint [6]
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Measured during the 9 week study phase
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Secondary outcome [7]
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Average total daily insulin (TDI)
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Assessment method [7]
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measure of insulin
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Timepoint [7]
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Measured during the 9 week study phase
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Secondary outcome [8]
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Average TDI/kg
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Assessment method [8]
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measure of insulin
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Timepoint [8]
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Measured during the 9 week study phase
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Secondary outcome [9]
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Average number of manual boluses/day
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Assessment method [9]
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count of average number of insulin boluses
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Timepoint [9]
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Measured during the 9 week study phase
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Secondary outcome [10]
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Average dose of insulin delivered by manual bolus/day
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Assessment method [10]
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measure of insulin
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Timepoint [10]
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Measured during the 9 week study phase
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Secondary outcome [11]
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Average number of hypoglycemic treatments when CGM is less than 3.9mmol/L
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Assessment method [11]
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Glucose metric from CGM
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Timepoint [11]
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Measured during the 9 week study phase
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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.
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Minimum age
16
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
5/09/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
31/01/2024
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Sample size
Target
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Accrual to date
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Final
20
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Christchurch
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Insulet Corporation
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT06181721
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT06181721
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