Evaluating Glucose Control Using a Next Generation Automated Insulin Delivery Algorithm in Patients With Type 1 and Type 2 Diabetes

NCT06181721 | Completed FDA Device

• 1 other identifier: EVOLUTION
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus

Keywords

Type 2 Diabetes T2D; Type 1 Diabetes T1D; Omnipod; Automated Insulin Delivery System

Outcome Measures

Primary Outcomes (2)

• Percentage of time in hypoglycemic range (defined as < 3.9 mmol/L (<70 mg/dL))

  Glucose metric from CGM

  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 during the 9 week study phase

Secondary Outcomes (11)

• Mean glucose value of all participants

  Measured during the 9 week study phase

• Percentage of time < 3.0 mmol/L (<54 mg/dL)

  Measured during the 9 week study phase

• Percentage of time > 10.0 mmol/L (>180 mg/dL)

  Measured during the 9 week study phase

• Percentage of time > 16.7 mmol/L (>300 mg/dL)

  Measured during the 9 week study phase

• Percentage of time between 3.9-10.0 mmol/L (70-180 mg/dL)

  Measured during the 9 week study phase

Study Arms (2)

Group A with Type 1 Diabetes

EXPERIMENTAL

Participants with Type 1 Diabetes

Device: Omnipod 5 Automated Glucose Control System

Group B with Type 2 Diabetes

EXPERIMENTAL

Participants with Type 2 Diabetes

Device: Omnipod 5 Automated Glucose Control System

Interventions

Omnipod 5 Automated Glucose Control System DEVICE

The Omnipod 5 Automated Glucose Control System will provide automated insulin delivery

Group A with Type 1 Diabetes; Group B with Type 2 Diabetes

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Insulet Corporation: lead

Study Sites (1)

University of Otago

Christchurch, 8140, New Zealand

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2023
• First Posted: December 26, 2023
• Study Start: September 5, 2023
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: April 2, 2024

Record last verified: 2024-04

Locations

NZ (1)