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Obtain preliminary safety and performance data on a settings initialization and adaptation algorithm used in conjunction with closed-loop control.
This feasibility study is a prospective, single arm, single center study with a run-in phase, followed by 13 weeks of Control-IQ technology use. By using an algorithm to more accurately initialize insulin delivery settings and adapt them over time, faster than typical HCP visits, users onboarding from multiple daily injections (MDI) will reach optimal glycemic outcomes faster.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control-IQ Technology with Algorithm Derived Initial Profile Settings and Regular Updates | Experimental | After CGM run-in, participants will begin use of Control-IQ technology with algorithm derived initial insulin delivery settings, then have regular settings updates from the algorithm through 13 weeks of use. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Automated Insulin Delivery Settings Initialization and Adaptation Algorithm | Device | All participants wearing the t:slim X2 insulin pump with Control-IQ technology, and wearing the Dexcom G6 sensor, will have algorithm derived insulin delivery profile settings initialization and updates at regular intervals. |
| Measure | Description | Time Frame |
|---|---|---|
| Severe Hypoglycemic Events | Number of Severe Hypoglycemic Events (with altered mental status) | 15 weeks |
| Diabetic Ketoacidosis Events | Number of Diabetic Ketoacidosis events as defined by the Diabetes Control and Complications Trial (DCCT) | 15 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Time < 54 mg/dL, Overall | CGM percent time < 54 mg/dL, Overall Study Participation | 15 weeks |
| Percent Time < 54 mg/dL, Daytime Outcomes | CGM percent time < 54 mg/dL, Daytime Outcomes between 06:00-00:00 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jordan E Pinsker, MD | Tandem Diabetes Care, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barbara Davis Center | Aurora | Colorado | 80045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38323362 | Result | Shah VN, Akturk HK, Trahan A, Piquette N, Wheatcroft A, Schertz E, Carmello K, Mueller L, White K, Fu L, Sassan-Katchalski R, Messer LH, Habif S, Constantin A, Pinsker JE. Safety and Feasibility Evaluation of Automated User Profile Settings Initialization and Adaptation With Control-IQ Technology. J Diabetes Sci Technol. 2024 Nov;18(6):1281-1287. doi: 10.1177/19322968241229074. Epub 2024 Feb 7. |
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Study performed at a single clinical site, Barbara Davis Center, from March to September 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates | Participants will begin use of Control-IQ technology with algorithm derived initial insulin delivery settings, then have regular settings updates from the algorithm through 13 weeks of use |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Male and female participants ≥ 18 years of age with type 1 diabetes, who were multiple daily injection (MDI) users, who have a baseline hemoglobin A1c at screening between 7.5 to 11%.
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| ID | Title | Description |
|---|---|---|
| BG000 | Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates | After CGM run-in, participants will begin use of Control-IQ technology with algorithm derived initial insulin delivery settings, then have regular settings updates from the algorithm through 13 weeks of use. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Severe Hypoglycemic Events | Number of Severe Hypoglycemic Events (with altered mental status) | Posted | Mean | Standard Deviation | number of events | 15 weeks |
|
|
15 weeks
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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 | MDI Run-In With CGM | Run-In with MDI therapy and CGM for 2 weeks. | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Severe Hypoglycemia | Endocrine disorders | Systematic Assessment | The event required assistance of another person due to altered consciousness, and required another person to actively administer carbohydrate, glucagon, or other resuscitative actions. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ecchymosis | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Supervisor Clinical Operations | Tandem Diabetes Care | +18778016901 | clinicalaffairs@tandemdiabetes.com |
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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 | Oct 1, 2021 | Jan 17, 2024 | Prot_SAP_000.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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|
| 15 weeks |
| Percent Time < 54 mg/dL, Overnight Outcomes | CGM percent time < 54 mg/dL, Overnight Outcomes between 00:00-06:00 | 15 weeks |
| Percent Time < 70 mg/dL, Overall | CGM percent time < 70 mg/dL, Overall Study Participation | 15 weeks |
| Percent Time < 70 mg/dL, Daytime Outcomes | CGM percent time < 70 mg/dL, Daytime Outcomes between 06:00-00:00 | 15 weeks |
| Percent Time < 70 mg/dL, Overnight Outcomes | CGM percent time < 70 mg/dL, Overnight Outcomes between 00:00-06:00 | 15 weeks |
| Percent of Time 70-140 mg/dL, Overall | CGM percent time 70-140 mg/dL, Overall Study Participation | 15 weeks |
| Percent of Time 70-140 mg/dL, Daytime Outcomes | CGM percent time 70-140 mg/dL, Daytime Outcomes between 06:00-00:00 | 15 weeks |
| Percent of Time 70-140 mg/dL, Overnight Outcomes | CGM percent time 70-140 mg/dL, Overnight Outcomes between 00:00-06:00 | 15 weeks |
| Percent of Time 70-180 mg/dL, Overall | CGM percent time 70-180 mg/dL, Overall Study Participation | 15 weeks |
| Percent of Time 70-180 mg/dL, Daytime Outcomes | CGM percent time 70-180 mg/dL, Daytime Outcomes between 06:00-00:00 | 15 weeks |
| Percent of Time 70-180 mg/dL, Overnight Outcomes | CGM percent time 70-180 mg/dL, Overnight Outcomes between 00:00-06:00 | 15 weeks |
| Percent Time > 180 mg/dL, Overall | CGM percent time > 180 mg/dL, Overall Study Participation | 15 weeks |
| Percent Time > 180 mg/dL, Daytime Outcomes | CGM percent time > 180 mg/dL, Daytime Outcomes between 06:00-00:00 | 15 weeks |
| Percent Time > 180 mg/dL, Overnight Outcomes | CGM percent time > 180 mg/dL, Overnight Outcomes between 00:00-06:00 | 15 weeks |
| Percent Time > 250 mg/dL, Overall | CGM percent time > 250 mg/dL, Overall Study Participation | 15 weeks |
| Percent Time > 250 mg/dL, Daytime Outcomes | CGM percent time > 250 mg/dL, Daytime Outcomes between 06:00-00:00 | 15 weeks |
| Percent Time > 250 mg/dL, Overnight Outcomes | CGM percent time > 250 mg/dL, Overnight Outcomes between 00:00-06:00 | 15 weeks |
| Median Sensor Glucose | CGM-measured median glucose (mg/dL) | 15 weeks |
| Total Daily Insulin Use | Total Daily Insulin Use (Units/Day) | 15 weeks |
| Total Daily Bolus Insulin Use | Total Daily Bolus Insulin Use (units/day) | 15 weeks |
| Total Daily Basal Insulin Use | Total Daily Basal Insulin Use (units/day) | 15 weeks |
| Physician Overrides/Physician Initiated Changes in Pump Settings | Number of physician overrides/physician initiated changes in pump settings during the entire study. | 13 weeks |
| Device Impact Score, as Reported on the Diabetes Impact and Satisfaction (DIDS) Scale at Study Completion | The Diabetes Impact and Satisfaction (DIDS) scale is an 11-item questionnaire focused on satisfaction related to insulin delivery devices (e.g., trust and ease of use) and diabetes- elated impact on daily life, such as worry around hypoglycemia and sleep interruptions. The last 4 questions assess diabetes impact on a scale of 1-10 (1=Never, 10=always), with a lower score means a better outcome. Mean score for overall diabetes impact is reported after 13 weeks using the system with adaptive therapy settings | 13 weeks |
| Device Satisfaction Score, as Reported on the the Diabetes Impact and Satisfaction (DIDS) Scale at Study Completion | The Diabetes Impact and Satisfaction (DIDS) scale is an 11-item questionnaire focused on satisfaction related to insulin delivery devices (e.g., trust and ease of use) and diabetes- elated impact on daily life, such as worry around hypoglycemia and sleep interruptions. The first 7 questions assess device satisfaction on a scale of 1-10 (1=strongly disagree, 10=strongly agree), with a higher score means a better outcome. Mean score for overall device satisfaction is reported after 13 weeks using the system with adaptive therapy settings | 13 weeks |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| HbA1c at Enrollment | Mean | Standard Deviation | percentage of glycated hemoglobin |
|
|
| Primary | Diabetic Ketoacidosis Events | Number of Diabetic Ketoacidosis events as defined by the Diabetes Control and Complications Trial (DCCT) | Posted | Mean | Standard Deviation | number of events | 15 weeks |
|
|
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| Secondary | Percent Time < 54 mg/dL, Overall | CGM percent time < 54 mg/dL, Overall Study Participation | Posted | Median | Inter-Quartile Range | percentage of time | 15 weeks |
|
|
|
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| Secondary | Percent Time < 54 mg/dL, Daytime Outcomes | CGM percent time < 54 mg/dL, Daytime Outcomes between 06:00-00:00 | Posted | Median | Inter-Quartile Range | percentage of time | 15 weeks |
|
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|
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| Secondary | Percent Time < 54 mg/dL, Overnight Outcomes | CGM percent time < 54 mg/dL, Overnight Outcomes between 00:00-06:00 | Posted | Median | Inter-Quartile Range | percentage of time | 15 weeks |
|
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|
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| Secondary | Percent Time < 70 mg/dL, Overall | CGM percent time < 70 mg/dL, Overall Study Participation | Posted | Median | Inter-Quartile Range | percentage of time | 15 weeks |
|
|
|
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| Secondary | Percent Time < 70 mg/dL, Daytime Outcomes | CGM percent time < 70 mg/dL, Daytime Outcomes between 06:00-00:00 | Posted | Median | Inter-Quartile Range | percentage of time | 15 weeks |
|
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|
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| Secondary | Percent Time < 70 mg/dL, Overnight Outcomes | CGM percent time < 70 mg/dL, Overnight Outcomes between 00:00-06:00 | Posted | Median | Inter-Quartile Range | percentage of time | 15 weeks |
|
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|
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| Secondary | Percent of Time 70-140 mg/dL, Overall | CGM percent time 70-140 mg/dL, Overall Study Participation | Posted | Median | Inter-Quartile Range | percentage of time | 15 weeks |
|
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|
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| Secondary | Percent of Time 70-140 mg/dL, Daytime Outcomes | CGM percent time 70-140 mg/dL, Daytime Outcomes between 06:00-00:00 | Posted | Median | Inter-Quartile Range | percentage of time | 15 weeks |
|
|
|
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| Secondary | Percent of Time 70-140 mg/dL, Overnight Outcomes | CGM percent time 70-140 mg/dL, Overnight Outcomes between 00:00-06:00 | Posted | Median | Inter-Quartile Range | percentage of time | 15 weeks |
|
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| Secondary | Percent of Time 70-180 mg/dL, Overall | CGM percent time 70-180 mg/dL, Overall Study Participation | Posted | Median | Inter-Quartile Range | percentage of time | 15 weeks |
|
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| Secondary | Percent of Time 70-180 mg/dL, Daytime Outcomes | CGM percent time 70-180 mg/dL, Daytime Outcomes between 06:00-00:00 | Posted | Median | Inter-Quartile Range | percentage of time | 15 weeks |
|
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|
|
| Secondary | Percent of Time 70-180 mg/dL, Overnight Outcomes | CGM percent time 70-180 mg/dL, Overnight Outcomes between 00:00-06:00 | Posted | Median | Inter-Quartile Range | percentage of time | 15 weeks |
|
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|
|
| Secondary | Percent Time > 180 mg/dL, Overall | CGM percent time > 180 mg/dL, Overall Study Participation | Posted | Median | Inter-Quartile Range | percentage of time | 15 weeks |
|
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|
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| Secondary | Percent Time > 180 mg/dL, Daytime Outcomes | CGM percent time > 180 mg/dL, Daytime Outcomes between 06:00-00:00 | Posted | Median | Inter-Quartile Range | percentage of time | 15 weeks |
|
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|
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| Secondary | Percent Time > 180 mg/dL, Overnight Outcomes | CGM percent time > 180 mg/dL, Overnight Outcomes between 00:00-06:00 | Posted | Median | Inter-Quartile Range | percentage of time | 15 weeks |
|
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|
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| Secondary | Percent Time > 250 mg/dL, Overall | CGM percent time > 250 mg/dL, Overall Study Participation | Posted | Median | Inter-Quartile Range | percentage of time | 15 weeks |
|
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|
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| Secondary | Percent Time > 250 mg/dL, Daytime Outcomes | CGM percent time > 250 mg/dL, Daytime Outcomes between 06:00-00:00 | Posted | Median | Inter-Quartile Range | percentage of time | 15 weeks |
|
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|
|
| Secondary | Percent Time > 250 mg/dL, Overnight Outcomes | CGM percent time > 250 mg/dL, Overnight Outcomes between 00:00-06:00 | Posted | Median | Inter-Quartile Range | percentage of time | 15 weeks |
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| Secondary | Median Sensor Glucose | CGM-measured median glucose (mg/dL) | Posted | Median | Inter-Quartile Range | mg/dL | 15 weeks |
|
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| Secondary | Total Daily Insulin Use | Total Daily Insulin Use (Units/Day) | Posted | Median | Inter-Quartile Range | units/day | 15 weeks |
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| Secondary | Total Daily Bolus Insulin Use | Total Daily Bolus Insulin Use (units/day) | Posted | Median | Inter-Quartile Range | units/day | 15 weeks |
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| Secondary | Total Daily Basal Insulin Use | Total Daily Basal Insulin Use (units/day) | Posted | Median | Inter-Quartile Range | units/day | 15 weeks |
|
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| Secondary | Physician Overrides/Physician Initiated Changes in Pump Settings | Number of physician overrides/physician initiated changes in pump settings during the entire study. | Posted | Mean | Standard Deviation | number of events | 13 weeks |
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| Secondary | Device Impact Score, as Reported on the Diabetes Impact and Satisfaction (DIDS) Scale at Study Completion | The Diabetes Impact and Satisfaction (DIDS) scale is an 11-item questionnaire focused on satisfaction related to insulin delivery devices (e.g., trust and ease of use) and diabetes- elated impact on daily life, such as worry around hypoglycemia and sleep interruptions. The last 4 questions assess diabetes impact on a scale of 1-10 (1=Never, 10=always), with a lower score means a better outcome. Mean score for overall diabetes impact is reported after 13 weeks using the system with adaptive therapy settings | Participants who completed the study | Posted | Mean | Standard Deviation | units on a scale | 13 weeks |
|
|
|
| Secondary | Device Satisfaction Score, as Reported on the the Diabetes Impact and Satisfaction (DIDS) Scale at Study Completion | The Diabetes Impact and Satisfaction (DIDS) scale is an 11-item questionnaire focused on satisfaction related to insulin delivery devices (e.g., trust and ease of use) and diabetes- elated impact on daily life, such as worry around hypoglycemia and sleep interruptions. The first 7 questions assess device satisfaction on a scale of 1-10 (1=strongly disagree, 10=strongly agree), with a higher score means a better outcome. Mean score for overall device satisfaction is reported after 13 weeks using the system with adaptive therapy settings | Participants who completed the study | Posted | Mean | Standard Deviation | units on a scale | 13 weeks |
|
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|
| 33 |
| 0 |
| 33 |
| 0 |
| 33 |
| EG001 | Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates | All participants wearing the t:slim X2 insulin pump with Control-IQ technology, and wearing the Dexcom G6 sensor, will have algorithm derived insulin delivery profile settings initialization and updates at regular intervals through 13 weeks of use. | 0 | 33 | 2 | 33 | 8 | 33 |
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| Pancreatitis | Infections and infestations | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Ketonemia | Endocrine disorders | Systematic Assessment |
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| COVID-19 | Infections and infestations | Systematic Assessment |
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| Edema | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |