Type 2 Diabetes MellitusNCT04617795
Omnipod® 5 Automated Insulin Delivery System in Patients With Type 2 Diabetes
A study testing Omnipod 5 Automated Insulin Delivery System in people with Type 2 Diabetes Mellitus, run by Insulet Corporation at 4 sites in United States.
Trial summary
The study subjects will be separated into 2 groups, depending on their previous insulin therapy with approximately 50% of subjects from each group, continuous glucose monitoring (CGM) naive. Group A will complete a 2-week Standard Therapy Phase followed by 8 weeks of Omnipod 5 system use. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Omnipod 5 Automated Insulin Delivery System
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 4 sitesUnited States
- Study dates
- 23 Nov 2020to 6 Mar 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age at time of consent 18-75 years
- Diagnosed with type 2 diabetes on insulin therapy by injection: basal-bolus (12 subjects) or basal only (12 subjects) regimens
- A1C 8.0-12.0%
- Has not used an insulin pump within 3 months of screening
- Willing to use only the following types of insulin during the study: Humalog, Novolog, Admelog or Apidra during the study
- Maximum insulin dose of 200 units/day
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- Stable doses over the last 4 weeks of other glucose-lowering medications as determined by Investigator
- Willing to wear the system continuously throughout the study
- Deemed appropriate for pump therapy per investigator's assessment considering previous history of severe hypoglycemic and hyperglycemic events, and other comorbidities
- Investigator has confidence that the subject has the cognitive ability and can successfully operate all study devices and can adhere to the protocol
- Must be willing to use the Dexcom App on the Omnipod 5 PDM as the sole source of Dexcom data (except for the Dexcom Follow App) during Automated Mode
- Subjects scoring ≥ 4 on the Clarke Questionnaire must agree to have an overnight companion, defined as someone who resides in the same home or building as the study subject and who can be available overnight
- Able to read and speak English fluently
- Willing and able to sign the Informed Consent Form (ICF)
Who cannot join
- A medical condition, which in the opinion of the investigator, would put the subject at an unacceptable safety risk
- Planned major surgery during the study
- History of severe hypoglycemia in the past 6 months
- History of diabetic ketoacidosis (DKA) in the past 6 months, unrelated to an intercurrent illness, infusion set failure or initial diagnosis
- Diagnosed with a blood dyscrasia or bleeding disorder
- Plans to receive blood transfusion over the course of the study
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- Currently diagnosed with anorexia nervosa or bulimia
- Currently on hemodialysis
- History of adrenal insufficiency
- Has taken oral or injectable steroids within the past 8-weeks or plans to take oral or injectable steroids during the study
- Unable to tolerate adhesive tape or has any unresolved skin condition in sensor or pump placement
- Plans to use insulin other than U-100 insulin during the Omnipod 5 phase of the study
- Cardiac disease with functional status New York Heart Association Class III or IV or 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.
- Pregnant or lactating, or is a woman of childbearing potential and not on acceptable form of birth control (acceptable includes abstinence, condoms, oral/injectable contraceptives, IUD, or implant)
- Participation in another clinical study using an investigational drug or device other than the Omnipod 5 in the preceding 30-days or intends to participate during the 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Emory University
Atlanta, Georgia, 30303
Atlanta Diabetes
Atlanta, Georgia, 30318
University of California
Los Angeles, California, 90022
International Diabetes Center
Saint Louis Park, Minnesota, 55416
About this study
Official title: Evaluating the Safety and Effectiveness of the Omnipod® 5 Automated Insulin Delivery System in Patients With Type 2 Diabetes
The study subjects will be separated into 2 groups, depending on their previous insulin therapy with approximately 50% of subjects from each group, continuous glucose monitoring (CGM) naive.
Group A will complete a 2-week Standard Therapy Phase followed by 8 weeks of Omnipod 5 system use.
Group B will complete a 2-week Standard Therapy Phase followed by 10 weeks of Omnipod 5 system use.
Group A and Group B will have an optional 6-month extension of Omnipod 5 system use
Read the detailed description
Basal-Bolus - Group A (N=12)
- 2 weeks standard therapy - using multiple daily injections (MDI) and Dexcom G6 continuous glucose monitoring (CGM) , followed by:
- 4 weeks Omnipod 5 system use in Automated Mode with optional bolus, followed by:
- 4 weeks Omnipod 5 system use in Automated Mode with simplified bolus
- 6-month optional extension using Automated Mode
Basal - Group B (N=12)
- 2 weeks standard therapy - using basal injection only and Dexcom G6 continuous glucose monitoring (CGM) , followed by:
- 2 weeks Omnipod 5 system use in Manual Mode with Dexcom G6 continuous glucose monitoring (CGM) - with fixed basal rate, no bolus, followed by:
- 4 weeks Omnipod 5 system use in Automated Mode with optional bolus, followed by:
- If % time in range 70-180 mg/dL during Automated Mode is ≤50%, 4 weeks Omnipod 5 system use in Automated Mode with simplified bolus, OR
- If % time in range 70-180 mg/dL during Automated Mode is >50%, 4 weeks Omnipod 5 system use in Automated Mode with optional bolus
- 6-month optional extension using Automated Mode
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Omnipod 5 Automated Insulin Delivery System
- Keywords
- T2D, Omnipod
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omnipod 5 Automated Insulin Delivery SystemDevice
The Omnipod 5 is a single hormone insulin delivery system intended for the management of diabetes in persons requiring insulin. Continuous subcutaneous insulin infusion may be delivered by user-defined settings (manual mode) or automatically adjusted in response to feedback from a continuous glucose monitor (CGM).
The Omnipod 5 can automatically increase insulin delivery based on sensor glucose values from the continuous glucose monitor (CGM) and can decrease or suspend delivery of insulin when the glucose value falls below or is predicted to fall below predefined threshold values.
The Omnipod 5 is designed to assist patients with diabetes in achieving glycemic targets set by their health care providers.
| Study group | Role | What they receive |
|---|---|---|
| Basal-Bolus (Group A) | Experimental | * 2 weeks standard therapy - using multiple daily injections (MDI) and Dexcom G6 Continuous Glucose Monitor (CGM), followed by:
* 4 weeks Omnipod 5 system use in Automated Mode with optional bolus, followed by:
* 4 weeks Omnipod 5 system use in Automated Mode with simplified bolus
* 6-month optional extension using Automated Mode Receives: Device: Omnipod 5 Automated Insulin Delivery System |
| Basal (Group B) | Experimental | * 2 weeks standard therapy - using basal injection only and Dexcom G6 Continuous Glucose Monitor (CGM), followed by:
* 2 weeks Omnipod 5 system use in Manual Mode with Dexcom G6 Continuous Glucose Monitor (CGM) - with fixed basal rate, no bolus, followed by:
* 4 weeks Omnipod 5 system use in Automated Mode with optional bolus, followed by:
* If % time in range 70-180 mg/dL during Automated Mode is ≤50%, 4 weeks Omnipod 5 system use in Automated Mode with simplified bolus, OR
* If % time in range 70-180 mg/dL during Automated Mode is >50%, 4 weeks Omnipod 5 system use in Automated Mode with optional bolus
* 6-month optional extension using Automated Mode Receives: Device: Omnipod 5 Automated Insulin Delivery System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hyperglycemia
Overall percentage of time ≥250 mg/dL during standard therapy phase and ALL phases of Automated Mode
Measured: 8-10 weeks and after 6-month optional extension
Hypoglycemia
Overall percentage of time <54 mg/dL during standard therapy phase and all phases of Automated Mode
Measured: 8-10 weeks and after 6-month optional extension
Secondary outcomes (10)
Percent of Time in Range 70-180 mg/dL
Glucose metric from study continuous glucose monitoring system
Measured: Automated Mode use (8-10 weeks and after 6-month optional extension) will be compared to the standard therapy phase (2 weeks) overall, separately for Group A and Group B
Percent of Time > 180 mg/dL
Glucose metric from study continuous glucose monitoring system
Measured: Automated Mode use (8-10 weeks and after 6-month optional extension) will be compared to the standard therapy phase (2 weeks) overall, separately for Group A and Group B
Percent of Time ≥ 300 mg/dL
Glucose metric from study continuous glucose monitoring system
Measured: Automated Mode use (8-10 weeks and after 6-month optional extension) will be compared to the standard therapy phase (2 weeks) overall, separately for Group A and Group B
Percent of Time < 70 mg/dL
Glucose metric from study continuous glucose monitoring system
Measured: Automated Mode use (8-10 weeks and after 6-month optional extension) will be compared to the standard therapy phase (2 weeks) overall, separately for Group A and Group B
Standard Deviation
Glucose metric from study continuous glucose monitoring system-measured glucose variability with the standard deviation
Measured: Automated Mode use (8-10 weeks and after 6-month optional extension) will be compared to the standard therapy phase (2 weeks) overall, separately for Group A and Group B
Coefficient of Variation (of Glucose)
Glucose metric from study continuous glucose monitoring system (CGM)-measured glucose variability with the coefficient of variation (CV). Calculated by dividing the standard deviation of CGM values by the mean CGM values in the observation period.
Measured: Automated Mode use (8-10 weeks and after 6-month optional extension) will be compared to the standard therapy phase (2 weeks) overall, separately for Group A and Group B
Mean Glucose
Glucose metric from study continuous glucose monitoring system
Measured: Automated Mode use (8-10 weeks and after 6-month optional extension) will be compared to the standard therapy phase (2 weeks) overall, separately for Group A and Group B
Total Daily Insulin (Units)
Measure of insulin requirements
Measured: Automated Mode use (8-10 weeks and after 6-month optional extension) will be compared to the standard therapy phase (2 weeks) overall, separately for Group A and Group B
Total Daily Insulin (Units/kg)
Measure of insulin requirements
Measured: Automated Mode use (8-10 weeks and after 6-month optional extension) will be compared to the standard therapy phase (2 weeks) overall, separately for Group A and Group B
Change in Hemoglobin A1c (HbA1c)
Measures average blood sugar levels over the past 3 months
Measured: End of study (8-10 weeks) and during extension (21-23 weeks and 24-26 weeks) compared to baseline (Days 57, 147, and 237 (Group A) or Days 71, 161, and 251 (Group B) compared to Day -30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2020
- Study start23 Nov 2020
- Primary completion6 Mar 2022
- Study completion6 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 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
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insulet Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anders Carlson, MD, Study chair, International Diabetes Center at Park NicolletAnne Peters, MD, Study chair, Keck School of Medicine of USC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04617795
- Sponsor's protocol ID
- OP5 in T2D Study G190270
- Status last verified
- Apr 2025
- First submitted
- 2 Nov 2020
- Last updated
- 18 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Davis GM, Peters AL, Bode BW, Carlson AL, Dumais B, Vienneau TE, Huyett LM, Ly TT. Glycaemic outcomes in adults with type 2 diabetes over 34 weeks with the Omnipod(R) 5 Automated Insulin Delivery System. Diabetes Obes Metab. 2025 Jan;27(1):143-154. doi: 10.1111/dom.15993. Epub 2024 Oct 9.
PubMed 39382001
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Safety and Effectiveness of the Omnipod® 5 Automated Insulin Delivery System in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT04617795
- Acronym / sponsor ID
- OP5 in T2D Study G190270
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- T2D, Omnipod
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Insulet CorporationIndustry (pharma, biotech, devices)
- Study start
- 23 Nov 2020 (actual)
- Primary completion
- 6 Mar 2022 (actual)
- Study completion
- 6 Mar 2022 (actual)
- First posted
- 5 Nov 2020 (actual)
- Results
- Posted 18 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study subjects will be separated into 2 groups, depending on their previous insulin therapy with approximately 50% of subjects from each group, continuous glucose monitoring (CGM) naive.
Group A will complete a 2-week Standard Therapy Phase followed by 8 weeks of Omnipod 5 system use.
Group B will complete a 2-week Standard Therapy Phase followed by 10 weeks of Omnipod 5 system use.
Group A and Group B will have an optional 6-month extension of Omnipod 5 system use
Detailed description
Basal-Bolus - Group A (N=12)
- 2 weeks standard therapy - using multiple daily injections (MDI) and Dexcom G6 continuous glucose monitoring (CGM) , followed by:
- 4 weeks Omnipod 5 system use in Automated Mode with optional bolus, followed by:
- 4 weeks Omnipod 5 system use in Automated Mode with simplified bolus
- 6-month optional extension using Automated Mode
Basal - Group B (N=12)
- 2 weeks standard therapy - using basal injection only and Dexcom G6 continuous glucose monitoring (CGM) , followed by:
- 2 weeks Omnipod 5 system use in Manual Mode with Dexcom G6 continuous glucose monitoring (CGM) - with fixed basal rate, no bolus, followed by:
- 4 weeks Omnipod 5 system use in Automated Mode with optional bolus, followed by:
- If % time in range 70-180 mg/dL during Automated Mode is ≤50%, 4 weeks Omnipod 5 system use in Automated Mode with simplified bolus, OR
- If % time in range 70-180 mg/dL during Automated Mode is >50%, 4 weeks Omnipod 5 system use in Automated Mode with optional bolus
- 6-month optional extension using Automated Mode
Study design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Basal-Bolus (Group A) | Experimental | Device: Omnipod 5 Automated Insulin Delivery System* 2 weeks standard therapy - using multiple daily injections (MDI) and Dexcom G6 Continuous Glucose Monitor (CGM), followed by: * 4 weeks Omnipod 5 system use in Automated Mode with optional bolus, followed by: * 4 weeks Omnipod 5 system use in Automated Mode with simplified bolus * 6-month optional extension using Automated Mode |
| Basal (Group B) | Experimental | Device: Omnipod 5 Automated Insulin Delivery System* 2 weeks standard therapy - using basal injection only and Dexcom G6 Continuous Glucose Monitor (CGM), followed by: * 2 weeks Omnipod 5 system use in Manual Mode with Dexcom G6 Continuous Glucose Monitor (CGM) - with fixed basal rate, no bolus, followed by: * 4 weeks Omnipod 5 system use in Automated Mode with optional bolus, followed by: * If % time in range 70-180 mg/dL during Automated Mode is ≤50%, 4 weeks Omnipod 5 system use in Automated Mode with simplified bolus, OR * If % time in range 70-180 mg/dL during Automated Mode is >50%, 4 weeks Omnipod 5 system use in Automated Mode with optional bolus * 6-month optional extension using Automated Mode |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Age at time of consent 18-75 years
- Diagnosed with type 2 diabetes on insulin therapy by injection: basal-bolus (12 subjects) or basal only (12 subjects) regimens
- A1C 8.0-12.0%
- Has not used an insulin pump within 3 months of screening
- Willing to use only the following types of insulin during the study: Humalog, Novolog, Admelog or Apidra during the study
Key exclusion criteria (16 listed)
- A medical condition, which in the opinion of the investigator, would put the subject at an unacceptable safety risk
- Planned major surgery during the study
- History of severe hypoglycemia in the past 6 months
- History of diabetic ketoacidosis (DKA) in the past 6 months, unrelated to an intercurrent illness, infusion set failure or initial diagnosis
- Diagnosed with a blood dyscrasia or bleeding disorder
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 Insulin Delivery SystemThe Omnipod 5 is a single hormone insulin delivery system intended for the management of diabetes in persons requiring insulin. Continuous subcutaneous insulin infusion may be delivered by user-defined settings (manual mode) or automatically adjusted in response to feedback from a continuous glucose monitor (CGM). The Omnipod 5 can automatically increase insulin delivery based on sensor glucose values from the continuous glucose monitor (CGM) and can decrease or suspend delivery of insulin when the glucose value falls below or is predicted to fall below predefined threshold values. The Omnipod 5 is designed to assist patients with diabetes in achieving glycemic targets set by their health care providers. | Device | Basal (Group B), Basal-Bolus (Group A) |
Primary outcome
Hyperglycemia
Time frame: 8-10 weeks and after 6-month optional extension
Overall percentage of time ≥250 mg/dL during standard therapy phase and ALL phases of Automated Mode
Hypoglycemia
Time frame: 8-10 weeks and after 6-month optional extension
Overall percentage of time <54 mg/dL during standard therapy phase and all phases of Automated Mode
10 secondary outcomes
Percent of Time in Range 70-180 mg/dL
Time frame: Automated Mode use (8-10 weeks and after 6-month optional extension) will be compared to the standard therapy phase (2 weeks) overall, separately for Group A and Group B
Percent of Time > 180 mg/dL
Time frame: Automated Mode use (8-10 weeks and after 6-month optional extension) will be compared to the standard therapy phase (2 weeks) overall, separately for Group A and Group B
Percent of Time ≥ 300 mg/dL
Time frame: Automated Mode use (8-10 weeks and after 6-month optional extension) will be compared to the standard therapy phase (2 weeks) overall, separately for Group A and Group B
Percent of Time < 70 mg/dL
Time frame: Automated Mode use (8-10 weeks and after 6-month optional extension) will be compared to the standard therapy phase (2 weeks) overall, separately for Group A and Group B
Standard Deviation
Time frame: Automated Mode use (8-10 weeks and after 6-month optional extension) will be compared to the standard therapy phase (2 weeks) overall, separately for Group A and Group B
Coefficient of Variation (of Glucose)
Time frame: Automated Mode use (8-10 weeks and after 6-month optional extension) will be compared to the standard therapy phase (2 weeks) overall, separately for Group A and Group B
Mean Glucose
Time frame: Automated Mode use (8-10 weeks and after 6-month optional extension) will be compared to the standard therapy phase (2 weeks) overall, separately for Group A and Group B
Total Daily Insulin (Units)
Time frame: Automated Mode use (8-10 weeks and after 6-month optional extension) will be compared to the standard therapy phase (2 weeks) overall, separately for Group A and Group B
Total Daily Insulin (Units/kg)
Time frame: Automated Mode use (8-10 weeks and after 6-month optional extension) will be compared to the standard therapy phase (2 weeks) overall, separately for Group A and Group B
Change in Hemoglobin A1c (HbA1c)
Time frame: End of study (8-10 weeks) and during extension (21-23 weeks and 24-26 weeks) compared to baseline (Days 57, 147, and 237 (Group A) or Days 71, 161, and 251 (Group B) compared to Day -30
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39382001Davis GM, Peters AL, Bode BW, Carlson AL, Dumais B, Vienneau TE, Huyett LM, Ly TT. Glycaemic outcomes in adults with type 2 diabetes over 34 weeks with the Omnipod(R) 5 Automated Insulin Delivery System. Diabetes Obes Metab. 2025 Jan;27(1):143-154. doi: 10.1111/dom.15993. Epub 2024 Oct 9.
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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.
Anders Carlson, MD study chair
International Diabetes Center at Park Nicollet
Anne Peters, MD study chair
Keck School of Medicine of USC
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omnipod 5 Automated Insulin Delivery System in people with Type 2 Diabetes Mellitus, run by Insulet Corporation at 4 sites in United States.
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 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 18 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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?
Yes. Results are posted in the registry (first posted 18 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Hyperglycemia (time frame: 8-10 weeks and after 6-month optional extension). 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 NCT04617795, which also lists 1 linked publication.
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 18 Apr 2025.