EVOLUTION trial (EValuating glucose contrOL Using a next generaTION automated insulin delivery algorithm in patients with type 1 and type 2 diabetes: EVOLUTION)

Not Applicable

Completed

• Conditions: Type 1 diabetes mellitus; Type 2 diabetes mellitus; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12623000623695
• Lead Sponsor: niversity of Otago

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-07
• Study Completion: 2023-12-22
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Age at time of consent 16+ years
2. 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.
3. A1C between 7.5-11.0% at screening
4. 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
5. Willing to use a Dexcom G6 CGM for the duration of the study
6. Willing to use the Omnipod® 5 Automated Insulin Delivery System during the study
7. 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
8. Willing to participate in at least 45 minutes of exercise and meal challenges during the 3 day hotel stay (participants with type 1 diabetes only)
9. Willing to use carbohydrate counting for determination of meal boluses
10. Willing and able to sign the Informed Consent Form (ICF) and/or has a parent/guardian willing and able to sign the ICF.

Exclusion Criteria

1. 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
2. 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.
3. History of severe hypoglycemia within the past 6 months
4. History of diabetic ketoacidosis or hyperglycemic hyperosmolar syndrome in the past 6 months, unrelated to an intercurrent illness or infusion set failure
5. History of moderate to severe preproliferative or proliferative retinopathy based on screening within the last 12 months.
6. 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.
7. 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.
8. Currently on a low carbohydrate diet of < 60 grams of carbohydrates per day
9. 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)
10. 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
11. 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.
12. 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.
13. Currently participating in another clinical study using an investigational drug or device
14. Recent (within the preceding 30 days) participation in a clinical study using an investigational drug
15. 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of time that glucose is <3.9 mmol/L as measured by continuous glucose monitor and further stratified as daytime (0600-2359hrs) or nighttime (0000-0559hrs).[ Continuous glucose monitoring throughout duration of phase 3 (3 days/2 nights), as compared to phase 1 (2 weeks). Further stratified by recommended bolus therapy.];Percentage of time that glucose is >13.9 mmol/L as measured by continuous glucose monitor and further stratified as daytime (0600-2359hrs) or nighttime (0000-0559hrs).[ Continuous glucose monitoring throughout duration of phase 3 (3 days/2 nights), as compared to phase 1 (2 weeks). Further stratified by recommended bolus therapy.]