Type 1 Diabetes
Conditions
Keywords
Type 1 Diabetes, Meal Boluses, Fully Closed Loop (FCL), AIDANET
Brief summary
A randomized 1:1 crossover trial that intends to demonstrate feasibility and safety of the Automated Insulin Delivery as Adaptive NETwork (AIDANET) system run in a new smaller network version, used in full closed loop (FCL) by adults who have been diagnosed with type 1 diabetes (T1D).
Detailed description
The study will be performed for about 36 hours at a local hotel. Following the hotel session, participants will undergo a 7 day/6-night Remote Monitored At-Home use session. A one-week control period gathering data on glycemic control and insulin administration with the participants usual care therapy will also be completed. Participants will be randomized 1:1, to either Group A (control period prior to AIDANET use) or Group B (control period after AIDANET use).
Interventions
DEVICEAIDANET
AIDANET is a fully automated, utilizing a Bolus Priming System (BPS) that recognizes meal ingestion and delivers a quick priming dose of insulin prior to extreme blood sugar excursions.
Sponsors
Tandem Diabetes Care, Inc.
DexCom, Inc.
Marc Breton
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants will be randomized 1:1 to assess a 1-week usual care period before use of the AIDANET system (Group A) or after use of the AIDANET system (Group B).
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Age ≥18.0 and ≤60 years old at time of consent 2. Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year 3. Currently using insulin pump for at least three months; Any pump, either open loop or hybrid closed loop may be used. 4. Currently using insulin for at least six months. 5. Willingness to switch to use a commercially approved personal insulin (e.g., lispro or aspart, or biosimilar approved products) within the study pump as directed by the study team. 6. Currently using a Dexcom G6 or G7 CGM. 7. Has one or more supportive companions knowledgeable about emergency procedures for severe hypoglycemia and able to contact emergency services and study staff that either lives with participant or located within approximately 30 minutes of participant and able to locate participant in the event of an emergency. 8. Participant not currently known to be pregnant or breastfeeding. 9. If participant capable of becoming pregnant, must agree to use a form of contraception to prevent pregnancy while a participant in the study (e.g. hormonal contraception, abstinence from heterosexual intercourse). A negative serum or urine pregnancy test will be required for all females 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. 10. Willingness to use the study FCL system (CGM, pump, and phone) during the relevant study period. 11. Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial. 12. Willingness to participate in all study procedures including the house/hotel session, exercise challenges (e.g., one hour per day during hotel), and to consume approximately 3 unannounced meals per day during the relevant portion of the supervised hotel session. 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 is capable of adhering to the protocol. 15. Participant is proficient in reading and writing English.
Exclusion criteria
1. Plans to start a new non-insulin glucose-lowering agent (e.g., GLP-1 receptor agonists, Symlin, DPP-4 inhibitors, sulfonylureas). Participants may be on a stable dose of such an agent for at least the past month. 2. Current use of an SGLT-2 or SGLT-1/2 inhibitor due to risk of euglycemic DKA. 3. Hemophilia or any other bleeding disorder. 4. History of severe hypoglycemic events with seizure or loss of consciousness in the last 12 months. 5. History of DKA event in the last 12 months. 6. History of chronic renal disease (Stage 4 or unstable Stage 3b per investigator judgment) or currently on peritoneal or hemodialysis. 7. History of adrenal insufficiency. 8. Currently being treated for a seizure disorder. 9. Hypothyroidism or hyperthyroidism that is not adequately treated. 10. Coronary artery disease or other heart condition that would prevent participation in moderate intensity exercise. 11. Use of oral or injectable steroids at the time of enrollment or within the last 4 weeks. 12. Planned surgery during the study period. 13. Known ongoing adhesive intolerance that is not well managed. 14. A condition, which in the opinion of the investigator or designee, would put the participant or study at risk. 15. Participation in another interventional trial at the time of enrollment. 16. Participant with a direct supervisor involved in the conduct of the trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Mean Continuous Glucose Monitor (CGM) Between the Week of the Usual Care Observational Period and the Week of AIDANET At-Home. | 2 weeks | This study represents a small pilot study to assess the safety and efficacy of the small-version AIDANET system and is not formally powered. Nevertheless, the randomized crossover design will allow for analysis of period effects between Group A and Group B. Comparison between these groups will be made to determine if a period effect can explain part of the benefit of the FCL system during the at-home period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Percent Time-in-range | 2 weeks | Difference in percent CGM samples in 70-180 mg/dL between the Week of the Usual Care Observational Period and the Week of AIDANET At-home. Represented as AIDANET minus Usual Care. |
| Difference in Percent Time-below-range | 2 weeks | Difference in CGM percent samples \< 70mg/dL between the Week of the Usual Care Observational Period and the Week of AIDANET At-home. Represented as AIDANET minus Usual Care. |
| Difference in Percent Time-in-tight-range | 2 weeks | Difference in percent CGM samples in 70-140 mg/dL between the Week of the Usual Care Observational Period and the Week of AIDANET At-home. Represented as AIDANET minus Usual Care. |
Countries
United States
Participant flow
Pre-assignment details
Eight participants with T1D provided informed consent. One did not pass the screening process and another withdrew prior to the study intervention. The remaining six participants were randomized and completed the trial in December 2024.
Participants by arm
| Arm | Count |
|---|---|
| Usual Care→AIDANET Participants will complete 7 days/6 nights at home usual care period using their personal equipment. Participants will then use the AIDANET system during a 3 days/2 nights hotel admission. Participants will continue to use the AIDANET system at home for 7 days/6 nights.
AIDANET: AIDANET is a fully automated, utilizing a Bolus Priming System (BPS) that recognizes meal ingestion and delivers a quick priming dose of insulin prior to extreme blood sugar excursions. | 4 |
| AIDANET→Usual Care Participants will use AIDANET system during a 3 days/2 nights hotel admission. Participants will continue to use the AIDANET system at home for 7 days/6 nights and then will complete 7 days/6 nights at home usual care period using their personal equipment.
AIDANET: AIDANET is a fully automated, utilizing a Bolus Priming System (BPS) that recognizes meal ingestion and delivers a quick priming dose of insulin prior to extreme blood sugar excursions. | 2 |
| Total | 6 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Usual Care→AIDANET | AIDANET→Usual Care | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 2 Participants | 6 Participants |
| Age, Continuous | 42.2 years STANDARD_DEVIATION 6.5 | 36.5 years STANDARD_DEVIATION 8.5 | 40.3 years STANDARD_DEVIATION 7.7 |
| BMI (kg/m2) | 27.7 kilograms per square-meter STANDARD_DEVIATION 3 | 33.8 kilograms per square-meter STANDARD_DEVIATION 1.5 | 29.7 kilograms per square-meter STANDARD_DEVIATION 3.9 |
| CGM use Dexcom G6 | 2 Participants | 1 Participants | 3 Participants |
| CGM use Dexcom G7 | 2 Participants | 1 Participants | 3 Participants |
| Diabetes duration (y) | 21.6 years STANDARD_DEVIATION 8.2 | 31.4 years STANDARD_DEVIATION 5.3 | 24.9 years STANDARD_DEVIATION 8.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants | 2 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Percentage of HbA1c (%) | 7.1 percentage STANDARD_DEVIATION 0.5 | 7.3 percentage STANDARD_DEVIATION 0.1 | 7.17 percentage STANDARD_DEVIATION 0.41 |
| Pump use Insulet / Omnipod 5 | 2 Participants | 0 Participants | 2 Participants |
| Pump use Tandem /t:slim X2 with Control IQ | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 2 Participants | 6 Participants |
| Region of Enrollment United States | 4 Participants | 2 Participants | 6 Participants |
| Sex: Female, Male Female | 2 Participants | 1 Participants | 3 Participants |
| Sex: Female, Male Male | 2 Participants | 1 Participants | 3 Participants |
| Weight (kg) | 81.3 kilograms STANDARD_DEVIATION 17.5 | 87.5 kilograms STANDARD_DEVIATION 0.5 | 83.4 kilograms STANDARD_DEVIATION 14.6 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 2 |
| other Total, other adverse events | 0 / 4 | 0 / 2 |
| serious Total, serious adverse events | 0 / 4 | 0 / 2 |
Outcome results
Primary
Change in the Mean Continuous Glucose Monitor (CGM) Between the Week of the Usual Care Observational Period and the Week of AIDANET At-Home.
This study represents a small pilot study to assess the safety and efficacy of the small-version AIDANET system and is not formally powered. Nevertheless, the randomized crossover design will allow for analysis of period effects between Group A and Group B. Comparison between these groups will be made to determine if a period effect can explain part of the benefit of the FCL system during the at-home period.
Time frame: 2 weeks
Population: One participant withdrew prior to study intervention. Results were only analyzed for participants who started and completed data collection.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care→AIDANET | Change in the Mean Continuous Glucose Monitor (CGM) Between the Week of the Usual Care Observational Period and the Week of AIDANET At-Home. | -6.8 miligrams per deciliter | Standard Deviation 15.1 |
| AIDANET→Usual Care | Change in the Mean Continuous Glucose Monitor (CGM) Between the Week of the Usual Care Observational Period and the Week of AIDANET At-Home. | -2.1 miligrams per deciliter | Standard Deviation 20.7 |
Secondary
Difference in Percent Time-below-range
Difference in CGM percent samples \< 70mg/dL between the Week of the Usual Care Observational Period and the Week of AIDANET At-home. Represented as AIDANET minus Usual Care.
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care→AIDANET | Difference in Percent Time-below-range | 0.93 percentage of time-below-range | Standard Deviation 2.1 |
| AIDANET→Usual Care | Difference in Percent Time-below-range | 0.06 percentage of time-below-range | Standard Deviation 0.45 |
Secondary
Difference in Percent Time-in-range
Difference in percent CGM samples in 70-180 mg/dL between the Week of the Usual Care Observational Period and the Week of AIDANET At-home. Represented as AIDANET minus Usual Care.
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care→AIDANET | Difference in Percent Time-in-range | 1.55 percentage of time-in-range | Standard Deviation 4.34 |
| AIDANET→Usual Care | Difference in Percent Time-in-range | 2.76 percentage of time-in-range | Standard Deviation 10.6 |
Secondary
Difference in Percent Time-in-tight-range
Difference in percent CGM samples in 70-140 mg/dL between the Week of the Usual Care Observational Period and the Week of AIDANET At-home. Represented as AIDANET minus Usual Care.
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care→AIDANET | Difference in Percent Time-in-tight-range | 1.69 percentage of time-in-tight-range | Standard Deviation 10.71 |
| AIDANET→Usual Care | Difference in Percent Time-in-tight-range | 4.01 percentage of time-in-tight-range | Standard Deviation 7.19 |