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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT07039981




Registration number
NCT07039981
Ethics application status
Date submitted
10/06/2025
Date registered
26/06/2025
Date last updated
14/07/2025

Titles & IDs
Public title
Evaluating Glucose Control Using a Next Generation Automated Insulin Delivery Algorithm in Adults With Type 2 Diabetes
Scientific title
Evaluating Glucose Control Using a Next Generation Automated Insulin Delivery Algorithm in Adults With Type 2 Diabetes
Secondary ID [1] 0 0
Evolution2
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 M system

Experimental: Experimental- Participants with Type 2 diabetes -


Treatment: Devices: Omnipod M system
The Omnipod M system will allow user to use a lower glucose target and improve systems glucose control
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of time in hypoglycaemic range (defined as < 3.9 mmol/L (<70 mg/dL))
Timepoint [1] 0 0
Between Day1 and Day 56
Primary outcome [2] 0 0
Percentage of time in hyperglycaemic range (defined as > 10.0 mmol/L (180 mg/dL))
Timepoint [2] 0 0
Between Day1 and Day 56
Primary outcome [3] 0 0
Incidence rate of hyperosmolar hyperglycaemic state (HHS) and/or diabetic ketoacidosis (DKA) (events per person months)
Timepoint [3] 0 0
Between Day1 and Day 56
Primary outcome [4] 0 0
Incidence rate of severe hypoglycaemia (SH) (events per person months)
Timepoint [4] 0 0
Between Day1 and Day 56

Eligibility
Key inclusion criteria
1. Age at time of consent aged 16-70 years (inclusive)
2. Type 2 Diabetes diagnosis based on Investigator's clinical judgement and meets the following:

* Currently using U-100 rapid-acting insulin analogs with insulin pump OR
* Basal-bolus, pre-mix, or basal only users and suitable for conversion to pump therapy for at least 3 months prior to screening. For basal-bolus and premix users, must have A1c < 12%. For basal only users must have A1c = 7% and < 12.0%.
3. Willing to use only the following types of U-100 insulin during the study: Humalog U-100, Novorapid, or their generic equivalents
4. Stable doses over the preceding 30 days of other glucose-lowering medications as determined by Investigator
5. Willing to use a Dexcom CGM for the duration of the study
6. Willing to use the investigational system(s) 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 receive real-time glucose alerts
9. Willing and able to sign the Informed Consent Form (ICF).
Minimum age
16 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Any medical condition, such as untreated malignancy, unstable cardiac disease, unstable 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), 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 A1c.
3. History of severe hypoglycaemia within the past 6 months
4. History of diabetic ketoacidosis or hyperglycaemic hyperosmolar syndrome in the past 6 months, unrelated to an intercurrent illness or infusion set failure.
5. History of 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. Pregnant, or is 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)
9. 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.
10. 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.
11. Currently participating in another clinical study using an investigational drug or device except for the SmartAdjust 2.0 Feasibility Study (Protocol #2024 FULL 20405)
12. Recent (within the preceding 30 days) participation in a clinical study using an investigational drug, excluding Omnipod device studies.
13. 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
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
1/07/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
8/12/2025
Actual
Sample size
Target
48
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT07039981