Diabetes MellitusEvolutionNCT06181721
Evaluating Glucose Control Using a Next Generation Automated Insulin Delivery Algorithm in Patients With Type 1 and Type 2 Diabetes
A study of Diabetes Mellitus, run by Insulet Corporation at 1 site in New Zealand.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Diabetes Mellitus
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNew Zealand
- Study dates
- 5 Sep 2023to 31 Jan 2024
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participants must meet all the following criteria to be included in the study:
- Age at time of consent 16+ years
- 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.
- A1C between 7.5-11.0% at screening
- 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
- Willing to use a Dexcom G6 CGM for the duration of the study
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- Willing to use the Omnipod® 5 Automated Insulin Delivery System during the study
- 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
- Willing to participate in at least 45 minutes of exercise and meal challenges during the 3 day hotel stay (Group A only)
- Willing to use carbohydrate counting for determination of meal boluses
- Willing and able to sign the Informed Consent Form (ICF) and/or has a parent/guardian willing and able to sign the ICF.
Who cannot join
- Participants who meet any of the following criteria will be excluded from the study:
- 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
- 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.
- History of severe hypoglycemia within the past 6 months
- History of diabetic ketoacidosis or hyperglycemic hyperosmolar syndrome in the past 6 months, unrelated to an intercurrent illness or infusion set failure
- History of moderate to severe preproliferative or proliferative retinopathy based on screening within the last 12 months.
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- 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.
- 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.
- Currently on a low carbohydrate diet of < 60 grams of carbohydrates per day
- 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)
- 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
- 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.
- 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.
- Currently participating in another clinical study using an investigational drug or device
- Recent (within the preceding 30 days) participation in a clinical study using an investigational drug
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
This study is a single-arm, observational clinical study that will enroll a maximum of 72 participants.
Participants between the ages of 16+ years with type 1 or type 2 diabetes currently using an insulin pump or receiving basal and bolus multiple daily injections (MDI), with an A1C between 7.5-11.0% at screening, will be recruited for the study.
Two participant groups will be recruited and will participate in up to 4 Phases:
- Group A (Participants with type 1 diabetes) will participate in Phase 1, Phase 2, Phase 3, and Phase 4
- Group B (Participants with type 2 diabetes) will participate in Phase 1, and Phase 4
Phase 1 (Group A and B) will include:
- 14 days of Standard Therapy while using a blinded Dexcom G6 CGM in an outpatient setting
Phase 2 (Group A only) will include:
- 48 hours of using build 1b.x of the Omnipod 5 System in Manual Mode in an outpatient setting
Phase 3 (Group A only) will include:
- 3 day/2 night supervised hotel stay using build 1b.x of the Omnipod 5 System in Automated Mode while also participating in meal and exercise challenges at a defined target glucose setting of 5.6 mmol/L (100 mg/dL). During the first 24 hours, participants will be instructed to not bolus for meals. For the following 24 hours, participants will be instructed to bolus for meals. At least 2 meals each day must contain at least 60 grams of carbohydrates. In addition, each day participants will take part in 45 minutes of exercise.
Phase 4 (Group A and B) will include:
- A total of 6 weeks using the Omnipod 5 System in Automated Mode in an outpatient setting at a defined target glucose setting of 5.6 mmol/L (100 mg/dL). During weeks 1-3, participants will be instructed to bolus for meals. During weeks 4-6, participants will be instructed to not bolus for meals.
After completion of a minimum of 10 participants for Group A, Phase 3, the data will be analysed and must meet prespecified criteria for Group A to proceed to Phase 4 and Group B to proceed to Phase 1 followed by Phase 4.
If the prespecified criteria are not met, software changes will be made and Group A, Phase 3 may be repeated either with the same participants or additional participants that meet the study criteria. Iterations of Group A, Phase 3 may continue until prespecified criteria are met.
- Conditions
- Diabetes Mellitus
- Being tested
- Omnipod 5 Automated Glucose Control System
- Keywords
- Type 2 Diabetes T2D, Type 1 Diabetes T1D, Omnipod, Automated Insulin Delivery System
- 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 Automated Glucose Control SystemDevice
The Omnipod 5 Automated Glucose Control System will provide automated insulin delivery
| Study group | Role | What they receive |
|---|---|---|
| Group A with Type 1 Diabetes | Experimental | Participants with Type 1 Diabetes Receives: Device: Omnipod 5 Automated Glucose Control System |
| Group B with Type 2 Diabetes | Experimental | Participants with Type 2 Diabetes Receives: Device: Omnipod 5 Automated Glucose Control System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of time in hypoglycemic range (defined as < 3.9 mmol/L (<70 mg/dL))
Glucose metric from CGM
Measured: At the end of Phase 3 and Phase 4 to compare to baseline values
Percentage of time in hyperglycemic range (defined as > 13.9 mmol/L (>250 mg/dL))
Glucose metric from CGM
Measured: measured during the 9 week study phase
Secondary outcomes (11)
Mean glucose value of all participants
Glucose metric from study provided continuous glucose monitor (CGM)
Measured: Measured during the 9 week study phase
Percentage of time < 3.0 mmol/L (<54 mg/dL)
Glucose metric from CGM
Measured: Measured during the 9 week study phase
Percentage of time > 10.0 mmol/L (>180 mg/dL)
Glucose metric from CGM
Measured: Measured during the 9 week study phase
Percentage of time > 16.7 mmol/L (>300 mg/dL)
Glucose metric from CGM
Measured: Measured during the 9 week study phase
Percentage of time between 3.9-10.0 mmol/L (70-180 mg/dL)
Glucose metric from CGM
Measured: Measured during the 9 week study phase
Standard deviation and coefficient of variation
Glucose metric from CGM measured glucose variability with the coefficient of variation (CV)
Measured: Measured during the 9 week study phase
Average total daily insulin (TDI)
measure of insulin
Measured: Measured during the 9 week study phase
Average TDI/kg
measure of insulin
Measured: Measured during the 9 week study phase
Average number of manual boluses/day
count of average number of insulin boluses
Measured: Measured during the 9 week study phase
Average dose of insulin delivered by manual bolus/day
measure of insulin
Measured: Measured during the 9 week study phase
Average number of hypoglycemic treatments when CGM is less than 3.9mmol/L
Glucose metric from CGM
Measured: Measured during the 9 week study phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2023
- Study start5 Sep 2023
- Primary completion31 Jan 2024
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insulet Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06181721
- Sponsor's protocol ID
- EVOLUTION
- Acronym
- Evolution
- Status last verified
- Apr 2024
- First submitted
- 14 Nov 2023
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Glucose Control Using a Next Generation Automated Insulin Delivery Algorithm in Patients With Type 1 and Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT06181721
- Acronym / sponsor ID
- Evolution / EVOLUTION
- Conditions
- Diabetes Mellitus
- Keywords
- Type 2 Diabetes T2D, Type 1 Diabetes T1D, Omnipod, Automated Insulin Delivery System
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Insulet CorporationIndustry (pharma, biotech, devices)
- Study start
- 5 Sep 2023 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 26 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is a single-arm, observational clinical study that will enroll a maximum of 72 participants.
Participants between the ages of 16+ years with type 1 or type 2 diabetes currently using an insulin pump or receiving basal and bolus multiple daily injections (MDI), with an A1C between 7.5-11.0% at screening, will be recruited for the study.
Two participant groups will be recruited and will participate in up to 4 Phases:
- Group A (Participants with type 1 diabetes) will participate in Phase 1, Phase 2, Phase 3, and Phase 4
- Group B (Participants with type 2 diabetes) will participate in Phase 1, and Phase 4
Phase 1 (Group A and B) will include:
- 14 days of Standard Therapy while using a blinded Dexcom G6 CGM in an outpatient setting
Phase 2 (Group A only) will include:
- 48 hours of using build 1b.x of the Omnipod 5 System in Manual Mode in an outpatient setting
Phase 3 (Group A only) will include:
- 3 day/2 night supervised hotel stay using build 1b.x of the Omnipod 5 System in Automated Mode while also participating in meal and exercise challenges at a defined target glucose setting of 5.6 mmol/L (100 mg/dL). During the first 24 hours, participants will be instructed to not bolus for meals. For the following 24 hours, participants will be instructed to bolus for meals. At least 2 meals each day must contain at least 60 grams of carbohydrates. In addition, each day participants will take part in 45 minutes of exercise.
Phase 4 (Group A and B) will include:
- A total of 6 weeks using the Omnipod 5 System in Automated Mode in an outpatient setting at a defined target glucose setting of 5.6 mmol/L (100 mg/dL). During weeks 1-3, participants will be instructed to bolus for meals. During weeks 4-6, participants will be instructed to not bolus for meals.
After completion of a minimum of 10 participants for Group A, Phase 3, the data will be analysed and must meet prespecified criteria for Group A to proceed to Phase 4 and Group B to proceed to Phase 1 followed by Phase 4.
If the prespecified criteria are not met, software changes will be made and Group A, Phase 3 may be repeated either with the same participants or additional participants that meet the study criteria. Iterations of Group A, Phase 3 may continue until prespecified criteria are met.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A with Type 1 Diabetes | Experimental | Device: Omnipod 5 Automated Glucose Control SystemParticipants with Type 1 Diabetes |
| Group B with Type 2 Diabetes | Experimental | Device: Omnipod 5 Automated Glucose Control SystemParticipants with Type 2 Diabetes |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Age at time of consent 16+ years
- 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.
- A1C between 7.5-11.0% at screening
- 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
- Willing to use a Dexcom G6 CGM for the duration of the study
Key exclusion criteria (16 listed)
- 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
- 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.
- History of severe hypoglycemia within the past 6 months
- History of diabetic ketoacidosis or hyperglycemic hyperosmolar syndrome in the past 6 months, unrelated to an intercurrent illness or infusion set failure
- History of moderate to severe preproliferative or proliferative retinopathy based on screening within the last 12 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omnipod 5 Automated Glucose Control SystemThe Omnipod 5 Automated Glucose Control System will provide automated insulin delivery | Device | Group A with Type 1 Diabetes, Group B with Type 2 Diabetes |
Primary outcome
Percentage of time in hypoglycemic range (defined as < 3.9 mmol/L (<70 mg/dL))
Time frame: At the end of Phase 3 and Phase 4 to compare to baseline values
Glucose metric from CGM
Percentage of time in hyperglycemic range (defined as > 13.9 mmol/L (>250 mg/dL))
Time frame: measured during the 9 week study phase
Glucose metric from CGM
11 secondary outcomes
Mean glucose value of all participants
Time frame: Measured during the 9 week study phase
Percentage of time < 3.0 mmol/L (<54 mg/dL)
Time frame: Measured during the 9 week study phase
Percentage of time > 10.0 mmol/L (>180 mg/dL)
Time frame: Measured during the 9 week study phase
Percentage of time > 16.7 mmol/L (>300 mg/dL)
Time frame: Measured during the 9 week study phase
Percentage of time between 3.9-10.0 mmol/L (70-180 mg/dL)
Time frame: Measured during the 9 week study phase
Standard deviation and coefficient of variation
Time frame: Measured during the 9 week study phase
Average total daily insulin (TDI)
Time frame: Measured during the 9 week study phase
Average TDI/kg
Time frame: Measured during the 9 week study phase
Average number of manual boluses/day
Time frame: Measured during the 9 week study phase
Average dose of insulin delivered by manual bolus/day
Time frame: Measured during the 9 week study phase
Average number of hypoglycemic treatments when CGM is less than 3.9mmol/L
Time frame: Measured during the 9 week study phase
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Diabetes Mellitus, run by Insulet Corporation at 1 site 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 11 inclusion and 16 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 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 (defined as < 3.9 mmol/L (<70 mg/dL)) (time frame: At the end of Phase 3 and Phase 4 to compare to baseline values). 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?
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 2 Apr 2024.