AzTrials
AzTrials

Diabetes MellitusNCT06547918

SmartAdjust 2.0 System With Type 1 and Type 2 Diabetes

A study testing Omnipod 5 SA2.0 System in people with Diabetes Mellitus, run by Insulet Corporation at 2 sites in New Zealand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 2 to 70 years
Conditions the study is for
Diabetes Mellitus
What is being tested?
Omnipod 5 SA2.0 System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
2 sitesNew Zealand
Study dates
18 Jul 2024to 8 Sep 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 70 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Individuals must meet all the following criteria at screening to be included in the study:
  • Age at time of consent 2-70 years (inclusive)
  • 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%.
  • Living with a parent or guardian if < 16 years old
Show all 14Show fewer
  • 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
  • Willing to use only the following types of U-100 insulin during the study: Humalog U-100, Novorapid, or their generic equivalents
  • Deemed appropriate for pump therapy per Investigator's assessment considering previous history of severe hypoglycemic and hyperglycemic events, and other comorbidities
  • Stable doses over the preceding 4 weeks of other glucose-lowering medications, as determined by Investigator, including within class dose equivalent medication
  • Stable doses over the preceding 4 weeks of weight loss medications that may affect glycemic control directly and/or indirectly, as determined by Investigator
  • Investigator has confidence that the participant and/or caregiver can safely operate all study devices and can adhere to the protocol
  • Willing to wear the system, including Pods, continuously throughout the study
  • If female of childbearing potential, willing and able to have pregnancy testing

Who cannot join

  • Individuals who meet any of the following criteria at screening will be excluded from study participation:
  • Any medical condition, which in the opinion of the Investigator, would put the participant at an unacceptable safety risk
  • 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
  • Any planned surgery during the study which could be considered major in the opinion of the Investigator
  • Severe retinopathy based on retinal screening performed within the last 24 months
  • 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
Show all 14Show fewer
  • History of diabetic ketoacidosis (DKA) or hyperosmolar hyperglycemic state (HHS) in the past 6 months, unrelated to an intercurrent illness or infusion failure
  • Unable to tolerate adhesive tape or has any unresolved skin condition in the area of sensor or pump placement
  • 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
  • Plans to receive blood transfusion over the course of the study
  • 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)
  • 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
  • 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
  • Participant is an employee of Insulet, an Investigator or Investigator's study team, or immediate family member of any of the aforementioned

Trial locations and contacts

2 sites in 1 country.

New Zealand2 sites

  • University of Otago, Christchurch

    Christchurch, 8011

  • Wellington Regional Hospital

    Wellington, 6021

Other trials in New Zealand

About this study

Official title: Safety and Effectiveness of the Omnipod® 5 SmartAdjust 2.0 System in Individuals With Type 1 and Type 2 Diabetes

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.

Read the detailed description

This is a single-arm study that will enroll up to 75 participants aged 2-70 years with Type 1 diabetes and aged 16-70 years with Type 2 diabetes in order to have a minimum of 48 participants (24 with Type 1 Diabetes and 24 with Type 2 Diabetes) initiate the use of the Omnipod 5 SA2.0 System.

The Study will take part in two periods. Participants who do not have the minimum requirement of CGM data will undergo 2 weeks of Standard Therapy while using a Dexcom G6 in an outpatient setting before proceeding to Period 1.

During period 1, all participants will use the Omnipod SmartAdjust 2.0 System in an outpatient setting for up to six weeks. Period 2 is an optional extension of time that allows participants to continue using the Omnipod 2.0 SmartAdjust System for an additional six months.

Being tested
Omnipod 5 SA2.0 System
Keywords
Type 1 Diabetes T1D, Type 2 Diabetes T2D, Omnipod
Medical subject headings
Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Omnipod 5 SA2.0 SystemDevice

    The Omnipod 5 SA2.0 System provides automated insulin delivery based on Continuous Glucose Monitoring (CGM) values.

Study groups in NCT06547918
Study groupRoleWhat they receive
Experimental: Participants with Type 1 and Type 2 diabetesExperimentalNot described
Receives: Device: Omnipod 5 SA2.0 System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of time in hypoglycemic range <3.9 mmol/L (<70 mg/dL) (assessed by diabetes type (type 1 and type 2))

    Glucose metric from study provided continuous glucose monitor (CGM)

    Measured: End of Period 1 and Period 2 (optional) compared to Standard Therapy

  2. Percentage of time in hyperglycemic range >13.9 mmol/L (>250 mg/dL) (assessed by diabetes type (type 1 and type 2))

    Glucose metric from study provided continuous glucose monitor (CGM)

    Measured: End of Period 1 which is upto 6 weeks and Period 2 which is upto 6 months (optional) compared to Standard Therapy

Secondary outcomes (11)

  1. Mean glucose (assessed by diabetes type (type 1 and type 2))

    Glucose metric from study provided continuous glucose monitor (CGM)

    Measured: End of Period 1 which is upto 6 weeks and Period 2 which is upto 6 months (optional) compared to Standard Therapy

  2. Percentage of time < 3.0 mmol/L (<54 mg/dL) (assessed by diabetes type (type 1 and type 2))

    Glucose metric from study provided continuous glucose monitor (CGM)

    Measured: End of Period 1 which is upto 6 weeks and Period 2 which is upto 6 months (optional) compared to Standard Therapy

  3. Percentage of time > 10.0 mmol/L (>180 mg/dL) (assessed by diabetes type (type 1 and type 2))

    Glucose metric from study provided continuous glucose monitor (CGM)

    Measured: End of Period 1 which is upto 6 weeks and Period 2 which is upto 6 months (optional) compared to Standard Therapy

  4. Percentage of time > 16.7 mmol/L (>300 mg/dL) (assessed by diabetes type (type 1 and type 2))

    Glucose metric from study provided continuous glucose monitor (CGM)

    Measured: End of Period 1 which is upto 6 weeks and Period 2 which is upto 6 months (optional) compared to Standard Therapy

  5. Percentage of time between 3.9-10.0 mmol/L (70-180 mg/dL) (assessed by diabetes type (type 1 and type 2))

    Glucose metric from study provided continuous glucose monitor (CGM)

    Measured: End of Period 1 which is upto 6 weeks and Period 2 which is upto 6 months (optional) compared to Standard Therapy

  6. Standard deviation (assessed by diabetes type (type 1 and type 2))

    Glucose metric from the continuous glucose monitor (CGM)-measured glucose variability with the standard deviation (SD)

    Measured: End of Period 1 which is upto 6 weeks and Period 2 which is upto 6 months (optional) compared to Standard Therapy

  7. Coefficient of variation (assessed by diabetes type (type 1 and type 2))

    Glucose metric from the continuous glucose monitor (CGM)-measured glucose variability with the coefficient of variation (CV)

    Measured: End of Period 1 which is upto 6 weeks and Period 2 which is upto 6 months (optional) compared to Standard Therapy

  8. Average total daily insulin (TDI) (assessed by diabetes type (type 1 and type 2))

    Measure of insulin requirements

    Measured: End of Period 1 which is upto 6 weeks and Period 2 which is upto 6 months (optional) compared to Standard Therapy

  9. Average TDI/kg (assessed by diabetes type (type 1 and type 2))

    Measure of insulin requirements

    Measured: End of Period 1 which is upto 6 weeks and Period 2 which is upto 6 months (optional) compared to Standard Therapy

  10. Incidence rate of severe hypoglycemia (events per person months) (assessed by diabetes type (type 1 and type 2))

    Measure of insulin requirements

    Measured: 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

  11. 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)

    Measure of insulin requirements

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Aug 2024
  2. Study start18 Jul 2024
  3. Primary completion8 Sep 2025
  4. Study completion8 Sep 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06547918
Sponsor's protocol ID
SA2.0 Feasibility (NZ)
Status last verified
Jan 2026
First submitted
1 Aug 2024
Last updated
22 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Omnipod 5 SA2.0 System in people with Diabetes Mellitus, run by Insulet Corporation at 2 sites in New Zealand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of time in hypoglycemic range <3.9 mmol/L (<70 mg/dL) (assessed by diabetes type (type 1 and type 2)) (time frame: End of Period 1 and Period 2 (optional) compared to Standard Therapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06547918.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in