Evaluating Glucose Control Using a Next-Generation AID Algorithm in Individuals With T1D (EVOLUTIONT1D)

Evaluation Glucose Control Using a Next-Generation Automated Insulin Delivery Algorithm in Individuals With Type 1 Diabetes: EVOLUTION T1D

Feasibility study to evaluate the safety and feasibility of Omnipod automated insulin delivery algorithms in individuals with type 1 diabetes. This study will enroll up to 80 participants to have a minimum of 48 participants to initiate the use of Omnipod. The study will include hotel and outpatient evaluation periods.

Study Overview

• Status: Recruiting
• Conditions: Type 1 Diabetes; Type 1 Diabetes Mellitus; Diabetes (DM)
• Intervention / Treatment: Device: Omnipod M System; Device: Omnipod S

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Trang Ly, MBBS, PhD; Phone Number: 978-600-7000; Email: APClinical@insulet.com
• Study Contact Backup: Name: Bonnie Dumais, RN; Phone Number: 978-600-7000; Email: APClinical@insulet.com

Study Locations

• New Zealand
  • Christchurch, New Zealand, 8140
    • Recruiting
    • University of Otago
    • Principal Investigator: Martin deBock, FRACP, PHD
    • Contact: Mercedes Burnside, MD; Email: mercedes@edgetrials.co.nz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Age at time of consent 2-70 years (inclusive)
• Type 1 diabetes diagnosis for at least 6 months, for those aged 8-70 years, or 3 months for those aged 2-7 years, based on Investigator assessment
• Basal/Bolus insulin delivery via multiple daily injections or insulin pump with or without automation
• Willing to use 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
• If using noninsulin glucose-lowering medications or weight reduction medications, dose has been stable for 6-weeks prior to screening; and participant is willing to not change the dose unless required for safety purposes.
• Investigator has confidence that the participant can safely operate all study devices and can adhere to the protocol
• Willing to wear the system continuously throughout the study
• Willing and able to sign the Informed Consent Form (ICF) or has a parent/guardian willing and able to sign the ICF. Assent will be obtained from participants per local regulatory requirements
• Able to read and understand English
• If of childbearing potential, willing and able to have pregnancy testing

Exclusion Criteria:

• Any medical condition, which in the opinion of the Investigator, would put the participant at an unacceptable safety risk. This may include untreated malignancy, unstable cardiac disease, unstable or end-stage renal disease, unstable proliferative retinopathy, unstable psychiatric conditions such as eating disorders, drug or alcohol abuse.
• Current or known history of coronary artery disease that is not stable with medical management, including unstable angina, or a history of myocardial infarction, percutaneous coronary intervention, coronary artery bypass grafting, or arrhythmias requiring intervention within the 12 months prior to screening
• Any planned surgery during the study which could be considered major in the opinion of the Investigator
• History of more than 1 severe hypoglycaemia in the past 6 months. Severe hypoglycaemia 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
• History of more than 1 diabetic ketoacidosis (DKA) in the past 6 months, unrelated to an intercurrent illness; kinked, dislodged, or occluded cannula; or initial diabetes diagnosis Unable to tolerate adhesive tape or has any unresolved skin condition that could impact sensor or pump placement
• Blood disorder or dyscrasia within 3 months prior to screening, which in the Investigator's opinion could interfere with determination of HbA1c
• Use of hydroxyurea
• Plans to receive blood transfusion over the course of the study
• Has taken systemic corticosteroids (oral or injectable) within 4 weeks or has had a local steroid injection (intraarticular, epidural) within 1 week prior to screening or plans to take oral or injectable steroids during the study
• Use of non-insulin glucose-lowering medication or weight loss medications other than metformin and/or GLP1, in the 4 weeks prior to screening. Participants taking metformin and/or GLP1 should remain on a steady dose without dose increases during study participation
• Pregnant or lactating, or is of childbearing potential and not using an 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); childbearing potential means that menstruation has started, and the participant is not surgically sterile or greater than 12 months post-menopausal).
• In the past 30-days, has participated in a clinical study using any investigational drug or any investigational device that in the opinion of the investigator may have therapeutic impact on their diabetes management. Additionally, may not intend to participate in any other interventional clinical 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 a member of Investigator's study team, or immediate family member of any of the aforementioned

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Adults with T1D using Omnipod M	Device: Omnipod M System; Participants will use the Omnipod M System
Experimental: Adults and pediatrics with T1D using Omnipod S	Device: Omnipod S; Participants will use the Omnipod S System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of time <54 mg/dL	CGM percent time <54 mg/dL compared to standard therapy	72-hour Omnipod M Hotel Period
Percentage of time <70 mg/dL	CGM percent time <70 mg/dL compared to standard therapy	72-hour Omnipod M Hotel Period
Percentage of time >180 mg/dL	CGM percent time >180 mg/dL compared to standard therapy	72-hour Omnipod M Hotel Period
Percentage of time <54 mg/dL	CGM percent time <54 mg/dL compared to standard therapy	4-week Omnipod M outpatient
Percentage of time <54 mg/dL	CGM percent time <54 mg/dL compared to initial data collection phase	Final 3 weeks of Omnipod S outpatient
Percentage of time <70 mg/dL	CGM percent time <70 mg/dL compared to standard therapy	4-week Omnipod M outpatient
Percentage of time <70 mg/dL	CGM percent time <70 mg/dL compared to initial data collection phase	Final 3-weeks Omnipod S outpatient
Percentage of time >180 mg/dL	CGM percent time >180 mg/dL compared to standard therapy	4-week Omnipod M outpatient
Percentage of time >180 mg/dL	CGM percent time >180 mg/dL compared to initial data collection phase	Final 3-weeks Omnipod S outpatient

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence rate of severe hypoglycemia (SH)	events per person months	72-hour hotel period and 4-week outpatient period
Incidence rate of diabetic ketoacidosis (DKA)	events per person months	72-hour hotel period and 4-week outpatient period
Mean glucose	Mean glucose compared to standard therapy	4-weeks Omnipod M outpatient
Mean glucose	Mean glucose compared to initial data collection	Final 3-weeks Omnipod S outpatient
Percentage of time >250 mg/dL	CGM percent time >250 mg/dL compared to baseline	4-weeks Omnipod M outpatient
Percentage of time >250 mg/dL	CGM percent time >250 mg/dL compared to initial data collection	Final 3-weeks Omnipod S outpatient
Percentage of time >300 mg/dL	CGM percent time >300 mg/dL compared to standard therapy	4-weeks Omnipod M outpatient
Percentage of time >300 mg/dL	CGM percent time >300 mg/dL compared to initial data collection phase	Final 3-weeks Omnipod S outpatient
Percentage of time 70-180 mg/dL	CGM percent time 70-180 mg/dL compared to standard therapy	4-weeks Omnipod M outpatient
Percentage of time 70-180 mg/dL	CGM percent time 70-180 mg/dL compared to initial data collection	Final 3-weeks Omnipod S outpatient
Standard Deviation	Standard deviation compared to standard therapy	4-weeks Omnipod M outpatient
Standard Deviation	Standard deviation compared to initial data collection	Final 3-weeks Omnipod S outpatient
Coefficient of variation	Coefficient of variation compared to standard therapy	4-weeks Omnipod M outpatient
Coefficient of variation	Coefficient of variation compared to standard therapy	Final 3-weeks Omnipod S outpatient
Average total daily insulin (TDI)	Average TDI compared to standard therapy	4-weeks Omnipod M outpatient
Average total daily insulin (TDI)	Average TDI compared to initial data collection	Final 3-weeks Omnipod S outpatient
Average TDI/kg	Average TDI/kg compared to standard therapy	4-weeks Omnipod M outpatient
Average TDI/kg	Average TDI/kg compared to initial data collection	Final 3-weeks Omnipod S outpatient
Post-prandial glycemic metrics	Descriptive statistics for CGM metrics during and following meals will be calculated for Omnipod M (hotel) and Omnipod S (outpatient)	Up to 4-hours following tracked meal
Post-exercise session glycemic metrics	Descriptive statistics for CGM metrics during and following exercise will be calculated for Omnipod M (hotel) and Omnipod S (outpatient)	Up to 2-hours following exercise
Incidence rate of severe hypoglycemia (SH)	events per person months	Final 3-weeks Omnipod S outpatient
Incidence rate of diabetic ketoacidosis (DKA)	events per person months	Final 3-weeks Omnipod S outpatient

Collaborators and Investigators

• Sponsor: Insulet Corporation

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: May 11, 2026
• First Submitted That Met QC Criteria: May 11, 2026
• First Posted (Actual): May 18, 2026

Study Record Updates

• Last Update Posted (Actual): July 20, 2026
• Last Update Submitted That Met QC Criteria: July 17, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Type 1 Diabetes; T1D; Omnipod; fully closed loop; Automated Insulin Delivery System; AID; FCL; Omnipod M; Omnipod S
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: EVOLUTION T1D

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes