None listed
Conditions
Brief summary
Studies indicate that a substantial proportion of people with type 2 diabetes do not meet recommended targets for blood glucose control; this highlights the need for better approaches to type 2 diabetes management. Automated Insulin Delivery (AID) is a gold standard therapy that aims to improve outcomes for people with diabetes. AID links an insulin pump and continuous glucose monitoring (CGM) to a mathematical program (algorithm) that automatically adjusts insulin delivery, to try and keep blood glucose levels in a normal range. In order to decrease burden, this study is testing how well a new AID system designed to be used without the announcement of meal boluses and using a concentrated insulin formulation, can safely control blood glucose.
Interventions
This is a multi-arm, non-randomised feasibility study with two participant cohorts.
Cohort A: EVOLUTION 2 participants and new T2D participants who have used the Omnipod M System configured for U-100 insulin for at least 2-weeks. A subset of Cohort A participants will start in a Supervised Hotel Phase. These are all Christchurch-based EVOLUTION2 participants and up to two additional new participants recruited from Christchurch. All Cohort A participants will proceed to an Outpatient Treatment
This is a multi-arm, non-randomised feasibility study with two participant cohorts. Cohort A: EVOLUTION 2 participants and new T2D participants who have used the Omnipod M System configured for U-100 insulin for at least 2-weeks. A subset of Cohort A participants will start in a Supervised Hotel Phase. These are all Christchurch-based EVOLUTION2 participants and up to two additional new participants recruited from Christchurch. All Cohort A participants will proceed to an Outpatient Treatment Phase following the completion of the Hotel Phase. Cohort B: New T2D participants who proceed directly to an Outpatient Treatment Phase. The study consists of up to 4 Phases in which Cohort A and Cohort B will take part in all or a subset of phases. Omnipod M Lead-In Phase (Cohort A (new participants only) - participants will complete a 2-week lead in phase using the Omnipod M System with U-100 insulin once they have the minimum CGM data requirement. Participants will be trained by study staff to use the Omnipod M system and will receive written training materials as well as access to phone contact with clinical staff for support. Participants will continue their usual lifestyle and have no specific exercise or diet requirements during the lead-in phase. Review of device data will be used to monitor adherence to the lead-in phase Omnipod M system use. New participants in Cohort A may participate in both the lead-in phase and the supervised hotel phase. Supervised Hotel Phase (subset of Cohort A (EVOLUTION 2 participants and/or new participants)) - participants will use the Omnipod M System with a novel insulin combination without changes to the system settings from using U-100 insulin. A minimum of 8 participants will be supervised by clinical staff for approximately 48 hours while undergoing meal and exercise challenges. Meal challenges will take place over 2 days and participants will consume at least 2 meals that consist of a minimum of 60g carbohydrates during the hotel stay. These are the only meal challenges to be completed. Study staff will document all meals and snacks consumed during the hotel stay, including a description and the grams of carbohydrate eaten. At least one exercise session will take place during the hotel stay and should occur immediately following a meal challenge. The exercise will consist of 45 minutes of mild intensity exercise (walking) and must be completed all at once. The exercise will be supervised by study staff who will carry emergency supplies to support participants if required. 7 participants will transition from the EVOLUTION2 study and 1 new participant will be enrolled to make the 8 participants who will take part in the supervised hotel phase. There are no specific inclusion criteria for the supervised hotel phase. There is no rest period between the supervised hotel phase and the commencement of the outpatient treatment phase. Outpatient Treatment Phase (Cohort A (all) and B participants) - once the Supervised Hotel Phase concludes, all of Cohort A will use the Omnipod M System with a novel insulin combination in an outpatient setting for 6 weeks. Safety criteria from the Supervised Hotel Phase will be reviewed to determine the insulin settings that all of Cohort A will use to best support outpatient use. Participants will be trained by study staff to use the Omnipod M system and will receive written training materials as well as access to phone contact with clinical staff for support. Participants of Cohort B will begin the use of the Omnipod M System with a novel insulin combination for 6 weeks following the Standard Therapy Phase at a standard starting insulin dose. The standard starting insulin dose is yet to be determined for Cohort B, however it will be determined from the results of previous feasibility studies including EVOLUTION2 in New Zealand. Participants who will be enrolled into Cohort B have never used the Omnipod M system previously. Cohort A and Cohort B participants may start the outpatient treatment phase at the same time. The novel insulin combination used will be the same for both Cohorts A and B. This is a concentrated insulin formulation that is currently approved for use, but not in the investigational device to be used in this study. During the outpatient treatment phase participants will have unrestricted meals and activity designed to emulate real world use. Participants will have an in-person or virtual visit approximately every 2 weeks. The visits will include review of concomitant medications, adverse events, device deficiencies and Omnipod M system and sensor data review. The visits will be conducted by qualified clinical study staff (doctors or nurses) experienced in the management of diabetes. Review of device data will be used to monitor adherence to the outpatient phase Omnipod M system use. A description of the EVOLUTION2 study (NCT07039981) can be found in the public trial registry at https://clinicaltrials.gov/.
Sponsors
Edge Trials Limited
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
16 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Age 16-70 years (inclusive) 2. Clinical diagnosis of type 2 diabetes for at least 6 months 3. On current insulin regimen (basal-bolus, basal only or premix) for at least 3 months 4. Basal-bolus users with HbA1c less than 108 mmol/mol, or basal only users with HbA1c greater than or equal to 64 mmol/mol and less than 108 mmol/mol 5. Willing to use the novel insulin combination 6. Deemed appropriate for pump therapy per Investigator's assessment 7. If using noninsulin glucose-lowering medications or weight-reduction medications, dose has been stable for 6 weeks and participant is willing to not change the dose unless required for safety purposes 8. If of childbearing potential, willing and able to have pregnancy testing 9. If enrolled into Cohort A and participating in the Hotel Phase, willing and able to participate in meal and exercise challenges 10. If currently enrolled in the EVOLUTION2 study (NCT07039981 - described at https://clinicaltrials.gov/), you may be eligible to enroll into Cohort A only of this study 11. If not currently enrolled in the EVOLUTION2 study, you may be eligible to enroll into Cohort A (new participants) if you are willing to take part in the lead-in phase. If not currently enrolled in the EVOLUTION2 study, you may be eligible to enroll into Cohort B and take part in the outpatient treatment phase following standard therapy.
Exclusion criteria
1. Any medical condition, which in the opinion of the Investigator, would put the participant at an unacceptable safety risk 2. Current or known history of coronary artery disease that is not stable with medical management, within the 12 months prior to screening 3. Any planned surgery during the study which could be considered major in the opinion of the Investigator 4. History of more than 1 severe hypoglycaemia in the past 6 months 5. History of more than 1 diabetic ketoacidosis (DKA) or hyperosmolar hyperglycaemic state (HHS) in the past 6 months, unrelated to an intercurrent illness; kinked, dislodged, or occluded cannula; or initial diabetes diagnosis 6. Unable to tolerate adhesive tape or has any skin condition that could impact sensor or pump placement 7. History of severe preproliferative or proliferative retinopathy based on screening within the last 24 months or per New Zealand screening guidelines 8. Pregnant or lactating, or is of childbearing potential and not using an acceptable form of birth control 9. Participation in another clinical study using an investigational drug or device, except for the EVOLUTION2 study, within 30-days or intends to participate in any other study during this study period 10. If currently participating in the EVOLUTION2 study, you may be eligible to enroll in Cohort A only of this study
Outcome results
None listed