Type 1 Diabetes
Conditions
Keywords
Artificial Pancreas (AP), Continuous Glucose Monitor (CGM), Closed Loop Control (CLC), Insulin Pump
Brief summary
A single-arm, multi-center, clinical study to assess the safety profile of the Tandem t:slim X2 with Control-IQ system in children with T1D aged 2-6 years old under free living condition
Detailed description
This clinical trial aims to demonstrate the safety of the Closed-Loop Control (CLC), also known as Artificial Pancreas (AP) named t:slim X2 with Control-IQ Technology and assess usability in a supervised setting for the treatment of type 1 diabetes (T1D) in young children (2-6 years old).
Interventions
Subjects will use the Tandem t:slim X2 with Control- IQ Technology and Dexcom G6 CGM to control their glycemia. The Tandem t:slim X2 with Control-IQ device is an automated insulin delivery pump that automatically adjusts insulin delivery to predicted and prevailing glucose levels, as measured by a Dexcom G6 continuous glucose monitor \[CGM\].
Sponsors
DexCom, Inc.
Tandem Diabetes Care, Inc.
University of Virginia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 6 Years
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 2 and \< 6 years old at the time of consent 2. Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least 3 months and using insulin at the time of enrollment 3. Use of an insulin pump in the past 3 months 4. Use of Dexcom G6 for at least 11 out of the last 14 days 5. Parent/guardian(s) have familiarity with and use of carbohydrate ratios for meal boluses 6. Living with one or more parent/guardian knowledgeable about emergency procedures for severe hypoglycemia and able to contact emergency services and study staff 7. At least one parent/guardian is willing to stay with the child during the hotel/house portion of the study on the dates selected by the study team 8. Investigator has confidence that the parent/guardian(s) can successfully operate all study devices and is capable of adhering to the protocol 9. Willingness to switch to lispro (Humalog) or aspart (Novolog) if not already, and to use no other insulin besides lispro (Humalog) or aspart (Novolog) during the study 10. Total daily insulin dose (TDD) of at least 5 U/day 11. Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial 12. Child participant and parent/guardian(s) willingness to participate in all training sessions as directed by study staff 13. Willingness to discontinue non-Tandem t:slim insulin pumps during the entire study 14. Willingness to wear a Dexcom G6 sensor during the entire study 15. An understanding and willingness to follow the protocol and sign informed consent
Exclusion criteria
1. Hypoglycemia induced seizure or loss of consciousness in the past 3 months 2. Diabetes Ketoacidosis in the past 3 months 3. Use of diluted insulin 4. Concurrent use of any non-insulin glucose-lowering agent 5. Hemophilia or any other bleeding disorder 6. A condition, which in the opinion of the investigator or designee, would put the participant or study at risk. These conditions may include: * Acute illness at the time of the enrollment visit (fever of 101 or higher, vomiting, diarrhea) * Addison's disease * Diagnosed at less than 1 year of age without positive antibodies * Decreased renal function * Cystic fibrosis * Other chronic conditions, such as an underlying seizure disorder 7. Participation in another pharmaceutical or device trial at the time of enrollment or during the study. 8. Having a family member(s) employed by Tandem Diabetes Care, Inc. or having a direct supervisor at place of employment who is also directly involved in conducting the clinical trial (as a study investigator, coordinator, etc.); or having a first-degree relative who is directly involved in conducting the clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Outcome | Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home. | Percentage of subjects with less than 6% time below 70mg/dL and less than 40% time above 180mg/dL. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Below 60 mg/dl. | Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home. | Percent of time spent below 60mg/dl. |
| Below 54 mg/dl. | Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home. | Percent of time spent below 54mg/dL. |
| Below 50mg/dl. | Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home. | Percent of time spent below 50mg/dL. |
| Above 180 mg/dl. | Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home. | Percent of time spent above 180mg/dl. |
| Above 250mg/dl. | Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home. | Percent of time spent above 250mg/dl. |
| Above 300 mg/dl. | Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home. | Percent of time spent above 300 mg/dl. |
| Below 70 mg/dl. | Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home. | Percent of time spent below 70 mg/dl. |
| Between 70-180mg/dl | Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home. | Percent of time spent between 70 mg/dl and 180mg/dl. |
| Number of Hypoglycemia Below 70 mg/dL | Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home. | Number of hypoglycemia events (below 70 mg/dL). |
| Average Number of Treatments. | The 5 day period of data collection included 48 hours of supervised hotel admission. The remaining 72 hours consisted of at-home Control IQ use under parental supervision and remote study staff monitoring. | Average number of carbohydrate treatments per day. Participants were treated with \ 16g fast-acting carbohydrates for CGM readings under 80mg/dL during the day and under 70mg/dL overnight (or at higher glycemic thresholds per parent discretion). A repeat treatment was considered if CGM value was\<80mg/dL after \ 20min. Hypoglycemic treatments could occur at any time per study physician request |
| Average of Carbohydrate Treatments (g). | The 5 day period of data collection included 48 hours of supervised hotel admission. The remaining 72 hours consisted of at-home Control IQ use under parental supervision and remote study staff monitoring. | Average amount of carbohydrates (grams) used as a treatment. Participants were treated with \ 16g fast-acting carbohydrates for CGM readings under 80mg/dL during the day and under 70mg/dL overnight (or at higher glycemic thresholds per parent discretion). A repeat treatment was considered if CGM value was\<80mg/dL after \ 20min. Hypoglycemic treatments could occur at any time per study physician request |
| Percent of Time Spent in Closed Loop | The 5 day period of data collection included 48 hours of supervised hotel admission. The remaining 72 hours consisted of at-home Control IQ use under parental supervision and remote study staff monitoring. | Percentage of the amount of time spent with the Control-IQ system running in closed loop mode. |
| CGM Consensus Goal | Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home. | Percentage of subjects with more than 70% time in 70-180mg/dL range with less than 4% time below 70mg/dL. |
| Between 70-140mg/dl. | Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home. | Percent of time spent between 70 mg/dl and 140mg/dl. |
Countries
United States
Participant flow
Recruitment details
12 participants were enrolled across three clinical sites.
Pre-assignment details
All participants enrolled completed the study.
Participants by arm
| Arm | Count |
|---|---|
| Artificial Pancreas Therapy Subjects will use the Tandem t:slim X2 with Control-IQ Technology + Dexcom G6 to automatically modulate their insulin delivery and control their glycemia.
Tandem t:slim X2 with Control-IQ Technology + Dexcom G6: Subjects will use the Tandem t:slim X2 with Control- IQ Technology and Dexcom G6 CGM to control their glycemia. The Tandem t:slim X2 with Control-IQ device is an automated insulin delivery pump that automatically adjusts insulin delivery to predicted and prevailing glucose levels, as measured by a Dexcom G6 continuous glucose monitor \[CGM\]. | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | Artificial Pancreas Therapy |
|---|---|
| Age, Continuous | 4.7 years STANDARD_DEVIATION 1 |
| Diabetes duration | 2.08 years STANDARD_DEVIATION 0.89 |
| HbA1c (%) | 7.3 percentage STANDARD_DEVIATION 0.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 12 Participants |
| Region of Enrollment United States | 12 participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 4 Participants |
| Total daily insulin (units) | 14.6 units STANDARD_DEVIATION 3.5 |
| Total insulin dose | 0.76 U/(kg*day) STANDARD_DEVIATION 0.14 |
| Weight | 19.3 kg STANDARD_DEVIATION 3.1 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 12 |
| other Total, other adverse events | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
Primary
Primary Outcome
Percentage of subjects with less than 6% time below 70mg/dL and less than 40% time above 180mg/dL.
Time frame: Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Artificial Pancreas Therapy | Primary Outcome | Baseline | 33 percentage of subjects |
| Artificial Pancreas Therapy | Primary Outcome | 5 days of AP Therapy | 83 percentage of subjects |
Secondary
Above 180 mg/dl.
Percent of time spent above 180mg/dl.
Time frame: Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Artificial Pancreas Therapy | Above 180 mg/dl. | Baseline | 34.1 percentage of time | Standard Deviation 17.3 |
| Artificial Pancreas Therapy | Above 180 mg/dl. | 5 days of AP Therapy | 25.7 percentage of time | Standard Deviation 12.1 |
Secondary
Above 250mg/dl.
Percent of time spent above 250mg/dl.
Time frame: Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Artificial Pancreas Therapy | Above 250mg/dl. | Baseline | 9.7 percentage of time |
| Artificial Pancreas Therapy | Above 250mg/dl. | 5 days of AP Therapy | 4.2 percentage of time |
Secondary
Above 300 mg/dl.
Percent of time spent above 300 mg/dl.
Time frame: Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Artificial Pancreas Therapy | Above 300 mg/dl. | Baseline | 3.4 percentage of time |
| Artificial Pancreas Therapy | Above 300 mg/dl. | 5 days of AP Therapy | 0.6 percentage of time |
Secondary
Average Number of Treatments.
Average number of carbohydrate treatments per day. Participants were treated with \ 16g fast-acting carbohydrates for CGM readings under 80mg/dL during the day and under 70mg/dL overnight (or at higher glycemic thresholds per parent discretion). A repeat treatment was considered if CGM value was\<80mg/dL after \ 20min. Hypoglycemic treatments could occur at any time per study physician request
Time frame: The 5 day period of data collection included 48 hours of supervised hotel admission. The remaining 72 hours consisted of at-home Control IQ use under parental supervision and remote study staff monitoring.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Artificial Pancreas Therapy | Average Number of Treatments. | 0.8 treatments/day |
Secondary
Average of Carbohydrate Treatments (g).
Average amount of carbohydrates (grams) used as a treatment. Participants were treated with \ 16g fast-acting carbohydrates for CGM readings under 80mg/dL during the day and under 70mg/dL overnight (or at higher glycemic thresholds per parent discretion). A repeat treatment was considered if CGM value was\<80mg/dL after \ 20min. Hypoglycemic treatments could occur at any time per study physician request
Time frame: The 5 day period of data collection included 48 hours of supervised hotel admission. The remaining 72 hours consisted of at-home Control IQ use under parental supervision and remote study staff monitoring.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Artificial Pancreas Therapy | Average of Carbohydrate Treatments (g). | 17.5 grams | Standard Deviation 17.6 |
Secondary
Below 50mg/dl.
Percent of time spent below 50mg/dL.
Time frame: Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Artificial Pancreas Therapy | Below 50mg/dl. | Baseline | 0.2 percentage of time |
| Artificial Pancreas Therapy | Below 50mg/dl. | 5 days of AP Therapy | 0.2 percentage of time |
Secondary
Below 54 mg/dl.
Percent of time spent below 54mg/dL.
Time frame: Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Artificial Pancreas Therapy | Below 54 mg/dl. | Baseline | 0.6 percentage of time |
| Artificial Pancreas Therapy | Below 54 mg/dl. | 5 days of AP Therapy | 0.3 percentage of time |
Secondary
Below 60 mg/dl.
Percent of time spent below 60mg/dl.
Time frame: Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Artificial Pancreas Therapy | Below 60 mg/dl. | Baseline | 1.6 percentage of time |
| Artificial Pancreas Therapy | Below 60 mg/dl. | 5 days of AP Therapy | 0.7 percentage of time |
Secondary
Below 70 mg/dl.
Percent of time spent below 70 mg/dl.
Time frame: Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Artificial Pancreas Therapy | Below 70 mg/dl. | Baseline | 3.7 percentage of time |
| Artificial Pancreas Therapy | Below 70 mg/dl. | 5 days of AP Therapy | 3.2 percentage of time |
Secondary
Between 70-140mg/dl.
Percent of time spent between 70 mg/dl and 140mg/dl.
Time frame: Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Artificial Pancreas Therapy | Between 70-140mg/dl. | Baseline | 41.8 percentage of time | Standard Deviation 15.9 |
| Artificial Pancreas Therapy | Between 70-140mg/dl. | 5 days of AP Therapy | 51.5 percentage of time | Standard Deviation 12.8 |
Secondary
Between 70-180mg/dl
Percent of time spent between 70 mg/dl and 180mg/dl.
Time frame: Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Artificial Pancreas Therapy | Between 70-180mg/dl | Baseline | 61.7 percentage of time | Standard Deviation 16.1 |
| Artificial Pancreas Therapy | Between 70-180mg/dl | 5 days of AP Therapy | 71.3 percentage of time | Standard Deviation 12.5 |
Secondary
CGM Consensus Goal
Percentage of subjects with more than 70% time in 70-180mg/dL range with less than 4% time below 70mg/dL.
Time frame: Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Artificial Pancreas Therapy | CGM Consensus Goal | Baseline | 8 percentage of participants |
| Artificial Pancreas Therapy | CGM Consensus Goal | 5 days of AP Therapy | 58 percentage of participants |
Secondary
Number of Hypoglycemia Below 70 mg/dL
Number of hypoglycemia events (below 70 mg/dL).
Time frame: Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Artificial Pancreas Therapy | Number of Hypoglycemia Below 70 mg/dL | Baseline | 2.13 hypoglycemia event | Standard Deviation 1.36 |
| Artificial Pancreas Therapy | Number of Hypoglycemia Below 70 mg/dL | 5 days of AP Therapy | 1.79 hypoglycemia event | Standard Deviation 0.79 |
Secondary
Percent of Time Spent in Closed Loop
Percentage of the amount of time spent with the Control-IQ system running in closed loop mode.
Time frame: The 5 day period of data collection included 48 hours of supervised hotel admission. The remaining 72 hours consisted of at-home Control IQ use under parental supervision and remote study staff monitoring.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Artificial Pancreas Therapy | Percent of Time Spent in Closed Loop | 96.6 percentage of time |