None listed
Conditions
Brief summary
This study tests the feasibility, safety and performance of an extended wear (5-day) Omnipod 5 Pod in people with type 1 diabetes (T1D) with low total daily insulin (TDI). The Insulet Omnipod 5 (OP5) Automated Insulin Delivery (AID) System will be used with the approved 3-day OP5 Pod for 7 days during the run-in period. The OP5 AID System will be used with the 5-day OP5 Pod during the extended wear period. Participants will wear the 5-day OP5 System for up to 5 days (120 hours) for each of the 3 consecutive wear periods (upper arm, abdomen, and upper buttock/thigh).
Interventions
This is a single-arm interventional study with two cohorts.
Cohort 1: Up to 10 participants aged 6 years and older with type 1 diabetes will use the approved Insulet Omnipod 5 (OP5) Automated Insulin Delivery (AID) System with 3-day Pod wear during the 7 day run-in period. The OP5 Pod is a small adhesive patch pump worn on the body. The cannula is automatically deployed directly under the Pod, creating an infusion site without external tubing. Participants apply the Pod to their body themselv
This is a single-arm interventional study with two cohorts. Cohort 1: Up to 10 participants aged 6 years and older with type 1 diabetes will use the approved Insulet Omnipod 5 (OP5) Automated Insulin Delivery (AID) System with 3-day Pod wear during the 7 day run-in period. The OP5 Pod is a small adhesive patch pump worn on the body. The cannula is automatically deployed directly under the Pod, creating an infusion site without external tubing. Participants apply the Pod to their body themselves by exposing the adhesive and placing the Pod. The cannula is then inserted automatically by interacting with the mobile App on a smartphone Controller. Participants will then transition to the extended wear period of the study in which they will use the OP5 AID system with 5-day Pod wear for each of 3 consecutive wear periods. The OP5 Pods will be worn for up to 5 days (120 hours) on the upper arm, abdomen, and upper buttock/thigh. Skin evaluation of the previously removed Pod infusion site will be conducted by site investigators at the time of removal. The total duration of the intervention for Cohort 1 is up to approximately 6 weeks. Strategies used to assess adherence to the intervention include a daily survey received by text message or email during the extended wear period. Participants will also have in-person visits to assess the Pod infusion site of each removed Pod during the extended wear period. Cohort 2: If at least 80% of Pods remain functional for 120 hours and there are no safety concerns within the extended wear period in Cohort 1, the same schedule as described above will be carried out in up to 50 participants aged 6 years and older with type 1 diabetes. These participants will use the approved Insulet Omnipod 5 (OP5) Automated Insulin Delivery (AID) System with 3-day Pod wear during the 7 day run-in period. Participants will then transition to the extended wear period of the study in which they will use the OP5 AID system with 5-day Pod wear for each of 3 consecutive wear periods. The OP5 Pods will be worn for up to 5 days (120 hours) on the upper arm, abdomen, and upper buttock/thigh. Skin evaluation of the previously removed Pod infusion site will be conducted by site investigators at the time of removal. The total duration of the intervention for Cohort 2 is up to approximately 6 weeks. Strategies used to assess adherence to the intervention include a daily survey received by text message or email during the extended wear period. Participants will also have in-person visits to assess the Pod infusion site of each removed Pod during the extended wear period
Sponsors
Edge Trials Limited
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
6 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1) Type 1 Diabetes diagnosis based on the Investigator’s clinical judgement for more than 6 months. 2) Aged 6 years and older at time of consent. 3) Using U-100 insulin (Humalog U-100, NovoRapid, or their generic equivalents). 4) Currently using an insulin pump. 5) Total daily insulin (TDI) of less than or equal to 40 units average of the most recent 14 days at the time of screening. 6) Low TDI variability (within 200% of the mean) measured by TDI use/variability over the most recent 14 days at the time of screening. 7) Current CGM user, with at least 80% usage in the most recent 14 days at time of screening. 8) Able and willing to wear the Dexcom G7 on their arm, and OP5 Pod on their upper arm, abdomen and upper buttock/thigh. 9) Willing to perform fingerstick BG and ketone testing with their personal blood glucose meter as instructed/required. 10) Willing to photograph/have photographs taken of insertion sites pre- and post-insertion and Pod cannulas post removal. 11) Willing and able to sign the Informed Consent Form (ICF).
Exclusion criteria
1) Pregnant, breastfeeding or is 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). 2) Dermatological conditions (such as skin infection, rash, hives) 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. 3) Currently participating in another clinical study using an investigational drug or device. 4) 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.
Outcome results
None listed