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| Name | Class |
|---|---|
| DexCom, Inc. | INDUSTRY |
| Tandem Diabetes Care, Inc. | INDUSTRY |
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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
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Artificial Pancreas Therapy | Experimental | Subjects will use the Tandem t:slim X2 with Control-IQ Technology + Dexcom G6 to automatically modulate their insulin delivery and control their glycemia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tandem t:slim X2 with Control-IQ Technology + Dexcom G6 | Device | 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]. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Outcome | Percentage of subjects with less than 6% time below 70mg/dL and less than 40% time above 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Below 70 mg/dl. | Percent of time spent 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. |
| Below 60 mg/dl. |
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Inclusion Criteria:
Exclusion Criteria:
Hypoglycemia induced seizure or loss of consciousness in the past 3 months
Diabetes Ketoacidosis in the past 3 months
Use of diluted insulin
Concurrent use of any non-insulin glucose-lowering agent
Hemophilia or any other bleeding disorder
A condition, which in the opinion of the investigator or designee, would put the participant or study at risk. These conditions may include:
Participation in another pharmaceutical or device trial at the time of enrollment or during the study.
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.
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| Name | Affiliation | Role |
|---|---|---|
| Marc Breton, PhD | University of Virginia Center for Diabetes Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 94304 | United States | ||
| Barbara Davis Center, University of Colorado |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33226837 | Result | Ekhlaspour L, Schoelwer MJ, Forlenza GP, DeBoer MD, Norlander L, Hsu L, Kingman R, Boranian E, Berget C, Emory E, Buckingham BA, Breton MD, Wadwa RP. Safety and Performance of the Tandem t:slim X2 with Control-IQ Automated Insulin Delivery System in Toddlers and Preschoolers. Diabetes Technol Ther. 2021 May;23(5):384-391. doi: 10.1089/dia.2020.0507. Epub 2020 Dec 8. |
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To be determined
After manuscript publication
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All participants enrolled completed the study.
12 participants were enrolled across three clinical sites.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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]. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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]. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Primary Outcome | Percentage of subjects with less than 6% time below 70mg/dL and less than 40% time above 180mg/dL. | Posted | Number | percentage of subjects | 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. |
|
Up to 14 days
Any untoward medical occurrence in a study participant, irrespective of the relationship between the adverse event and the device(s) under investigation for reportable adverse events for this protocol.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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]. |
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Short term study in a limited number of individuals significantly limits the generalization of the results to clinical care
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marc Breton, PhD | University of Virginia Center for Diabetes Technology | 434-982-6484 | mb6nt@virginia.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 30, 2019 | Feb 15, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 27, 2019 | Feb 15, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D019397 | Pancreas, Artificial |
| ID | Term |
|---|---|
| D001187 | Artificial Organs |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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|
|
Percent of time spent below 60mg/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. |
| Below 54 mg/dl. | Percent of time spent below 54mg/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. |
| Below 50mg/dl. | Percent of time spent 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. |
| Above 180 mg/dl. | Percent of time spent above 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. |
| Above 250mg/dl. | Percent of time spent 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. |
| Above 300 mg/dl. | Percent of time spent 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. |
| Between 70-140mg/dl. | Percent of time spent between 70 mg/dl and 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. |
| Between 70-180mg/dl | Percent of time spent between 70 mg/dl and 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. |
| Number of Hypoglycemia Below 70 mg/dL | Number of hypoglycemia events (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. |
| 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 | 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 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 | 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. |
| Percent of Time Spent in Closed Loop | Percentage of the amount of time spent with the Control-IQ system running in closed loop mode. | 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. |
| CGM Consensus Goal | Percentage of subjects with more than 70% time in 70-180mg/dL range with less than 4% time below 70mg/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. |
| Aurora |
| Colorado |
| 80045 |
| United States |
| University of Virginia Center for Diabetes Technology | Charlottesville | Virginia | 22903 | United States |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Diabetes duration | Mean | Standard Deviation | years |
|
| HbA1c (%) | Mean | Standard Deviation | percentage |
|
| Weight | Mean | Standard Deviation | kg |
|
| Total insulin dose | Total insulin dose U/(kg*day) | Mean | Standard Deviation | U/(kg*day) |
|
| Total daily insulin (units) | Mean | Standard Deviation | units |
|
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| Secondary | Below 70 mg/dl. | Percent of time spent below 70 mg/dl. | Posted | Mean | Inter-Quartile Range | percentage of time | 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. |
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| Secondary | Below 60 mg/dl. | Percent of time spent below 60mg/dl. | Posted | Mean | Inter-Quartile Range | percentage of time | 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. |
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| Secondary | Below 54 mg/dl. | Percent of time spent below 54mg/dL. | Posted | Mean | Inter-Quartile Range | percentage of time | 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. |
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| Secondary | Below 50mg/dl. | Percent of time spent below 50mg/dL. | Posted | Mean | Inter-Quartile Range | percentage of time | 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. |
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| Secondary | Above 180 mg/dl. | Percent of time spent above 180mg/dl. | Posted | Mean | Standard Deviation | percentage of time | 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. |
|
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|
| Secondary | Above 250mg/dl. | Percent of time spent above 250mg/dl. | Posted | Mean | Inter-Quartile Range | percentage of time | 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. |
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| Secondary | Above 300 mg/dl. | Percent of time spent above 300 mg/dl. | Posted | Mean | Inter-Quartile Range | percentage of time | 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. |
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| Secondary | Between 70-140mg/dl. | Percent of time spent between 70 mg/dl and 140mg/dl. | Posted | Mean | Standard Deviation | percentage of time | 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. |
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| Secondary | Between 70-180mg/dl | Percent of time spent between 70 mg/dl and 180mg/dl. | Posted | Mean | Standard Deviation | percentage of time | 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. |
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| Secondary | Number of Hypoglycemia Below 70 mg/dL | Number of hypoglycemia events (below 70 mg/dL). | Posted | Mean | Standard Deviation | hypoglycemia event | 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. |
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| 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 | Posted | Mean | Inter-Quartile Range | treatments/day | 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. |
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| 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 | Posted | Mean | Standard Deviation | grams | 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. |
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| 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. | Posted | Mean | Inter-Quartile Range | percentage of time | 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. |
|
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| 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. | Posted | Number | percentage of participants | 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. |
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| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |