Type 1 Diabetes (T1D)
Conditions
Keywords
Automated insulin delivery as Adaptive Network (AIDANET), Fully automated Closed Loop (FCL), Hybrid Closed Loop (HCL), Continuous subcutaneous insulin infusion (CSII), Insulin Pump, Tandem Mobi system, Anticipatory Closed Loop (ACL)
Brief summary
This study is a randomized cross-over trial comparing AIDANET with Anticipation to AIDANET in FCL without Anticipation. Participants will complete 4 weeks of AID data collection which will be used to establish baseline and initialize the control algorithm. Participants will then be randomized to one of two groups: Group A: AIDANET in FCL with Anticipation (AIDANET+ACL), and Group B: AIDANET in FCL without Anticipation (AIDANET+FCL). The study duration of each group is 4 weeks each. The order of these two phases will be dependent upon randomization.
Detailed description
The UVA AIDANET algorithm is intended for use by patients with T1D to control the subcutaneous infusion of insulin and aid in their T1D self-management. AIDANET automatically adjusts insulin delivery every 5 minutes in response to CGM values. AIDANET can be used with meal announcement (hybrid closed loop, HCL), without meal announcement (full closed loop, FCL), and with meal anticipation (anticipatory closed loop, ACL). The purpose of this study is to demonstrate superior glycemic control when using anticipation within our latest Automated Insulin Delivery as Adaptive NETwork (AIDANET) in FCL with Anticipation (AIDANET+ACL) vs. AIDANET in FCL without Anticipation.
Interventions
Usual Care
DEVICEAIDANET + Fully Closed Loop (FCL)
All participants will use AIDANET in FCL mode with instructions to avoid announcing meal boluses whenever possible during the four weeks.
DEVICEAIDANET + Anticipatory Closed Loop (ACL)
All insulin will be delivered automatically. The algorithm will review past behaviors to determine the amount of insulin that will be needed for a meal.
Sponsors
Sue Brown
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Tandem Diabetes Care, Inc.
DexCom, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participant Inclusion Criteria 1. Age ≥18.0 years old at time of consent 2. Clinical diagnosis, based on investigator assessment, of T1D for \> 1 year. 3. Having used an FDA approved AID system within the last 6 months (can be intermittent use). 4. Currently using insulin for \>6 months. 5. Willingness to switch to use an FDA-approved personal insulin for the study pump (e.g., lispro or aspart, or biosimilar FDA-approved products) as directed by the study team. 6. Has one or more supportive companions knowledgeable about emergency procedures for severe hypoglycemia and able to contact emergency services and study staff who either lives with participant or located within approximately 30 minutes of participant and able to locate participant in the event of an emergency. 7. Participant not currently known to be pregnant or breastfeeding. 8. If participant can become pregnant, they must agree to use a form of contraception to prevent pregnancy while a participant in the study. A negative serum or urine pregnancy test will be required for all participants of childbearing potential. Participants who become pregnant will be discontinued from the study. Also, participants who during the study develop and express the intention to become pregnant within the timespan of the study will be discontinued. 9. Willingness to wear a Dexcom CGM during each of the study phases. 10. Willingness to use the study AIDANET system (CGM, pump, and phone) during the relevant study periods. 11. Willingness not to start any new non-insulin glucose-lowering agent during the trial. 12. Willingness to participate in all study procedures including in person training. 13. Access to internet at home and willingness to upload data during the study as needed. 14. Investigator has confidence that the participant can successfully operate all study devices and can adhere to the protocol. 15. Participant is proficient in reading and verbal communication in English. Participant
Exclusion criteria
The participant must not have any
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time in range 70-140 mg/dL as computed by the study CGM | 8 weeks | Computed as the number of estimated glucose values ≥70mg/dL and \<140mg/dL divided by the number of valid values (defined as a number between 39 and 401) |
Countries
United States
Contacts
CONTACTAndrea Riana, MD
CONTACTLaura Kollar, RN
PRINCIPAL_INVESTIGATORSue A Brown, MD
University of Virginia Center for Diabetes Technology
Outcome results
None listed