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| Name | Class |
|---|---|
| University of California, San Diego | OTHER |
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Post-approval 522 study designed to collect primarily safety data on the US FDA-cleared product, t:slim X2 insulin pump with Control-IQ technology (Control-IQ system).
Post-approval study designed to collect primarily safety data on the US FDA-cleared product, t:slim X2 insulin pump with Control-IQ technology (Control-IQ system), by assessing the rate of severe hypoglycemia (SH) and diabetic ketoacidosis (DKA) during the first 12 months of use. Secondary endpoints assessing the effectiveness of this product in real-world use by assessing the impact on patients' glycemic outcomes and user experience will also be collected. The Control-IQ system will be used as intended and in accordance with FDA-approved labeling.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pump Naive | New to insulin pump use |
| |
| 6-13 YO | Subjects between the age of 6-13 years old. |
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| 14-17 YO | Subjects between the age of 14-17 years old. |
| |
| Adults (18+) | Subjects are 18 years old and older. |
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| CGM Naive | Subjects have not used CGM in the 30 days prior to enrollment. |
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| HbA1c more than or equal to 8.5% | Subjects have an HbA1c of more than or equal to 8.5% in the 3 months prior to enrollment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| t:slim X2 pump with Control-IQ technology | Device | Real-world use |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence Rates of Severe Hypoglycemia (SH) | Overall incidence rate of events per 100 patient years | 12 months |
| Incidence Rates of Diabetic Ketoacidosis (DKA) | Overall incidence rate of events per 100 patient years | 12 months |
| Percent of Boluses Using the Auto Population Feature Resulting in Fewer Readings Less Than 70 mg/dL Than Those Not Using the Feature | Percent of boluses using the auto population feature resulting in at least one reading less than 70 mg/dL than those not using the feature, in every pre-bolus glucose range examined. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Time in Range 70 - 180 mg/dL | CGM measured percent time in range 70 - 180 mg/dL during 12 months of Control-IQ use | 12 months |
| Percent Time Greater Than 180 mg/dL | CGM measured percent time greater than 180 mg/dL during 12 months of Control-IQ use |
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Inclusion Criteria:
Exclusion Criteria:
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All subjects who start therapy with the Control-IQ System once the study is approved to start, that meet the indications for use and the study eligibility criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Jordan Pinsker, MD | Tandem Diabetes Care, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tandem Diabetes | San Diego | California | 92121 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37782904 | Result | Graham R, Mueller L, Manning M, Habif S, Messer LH, Pinsker JE, Aronoff-Spencer E. Real-World Use of Control-IQ Technology Is Associated with a Lower Rate of Severe Hypoglycemia and Diabetic Ketoacidosis Than Historical Data: Results of the Control-IQ Observational (CLIO) Prospective Study. Diabetes Technol Ther. 2024 Jan;26(1):24-32. doi: 10.1089/dia.2023.0341. Epub 2023 Oct 26. |
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3157 participants completed the baseline survey and were enrolled, but only 3061 had started closed-loop and had adequate data available for analysis.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Enrolled Participants | All participants with analyzable data (minimum of 75% CGM data available for at least 21 days) t:slim X2 pump with Control-IQ technology: Real-world use |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Enrolled Participants | All participants who started the monthly surveys. t:slim X2 pump with Control-IQ technology: Real-world use |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Incidence Rates of Severe Hypoglycemia (SH) | Overall incidence rate of events per 100 patient years | Posted | Mean | Standard Deviation | events per 100 patient years | 12 months |
|
12 months
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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 | All Enrolled Participants | All participants with analyzable data t:slim X2 pump with Control-IQ technology: Real-world use |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ketosis | Endocrine disorders | Systematic Assessment | Ketosis without DKA, evaluated in medical facility. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Affairs | Tandem Diabetes Care | 877-801-6901 | 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 | Feb 17, 2022 | Dec 6, 2023 | Prot_SAP_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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| HbA1c less than or equal to 8.5% | Subjects have an HbA1c of less than or equal to 8.5% in the 3 months prior to enrollment. |
|
| 12 months |
| Percent Time Greater Than 250 mg/dL | CGM measured percent time greater than 250 mg/dL during 12 months of Control-IQ use | 12 months |
| Percent Time Less Than 70 mg/dL | CGM measured percent time less than 70 mg/dL during 12 months of Control-IQ use | 12 months |
| Percent Time Less Than 54 mg/dL | CGM measured percent time less than 54 mg/dL during 12 months of Control-IQ use | 12 months |
| Diabetes Impact and Satisfaction Scale (DIDS), Satisfaction Score | DIDS satisfaction score after 12 months of Control-IQ use. Score range from 0-10 with higher scores indicating better outcome. | 12 months |
| Diabetes Impact and Satisfaction Scale (DIDS), Impact Score | DIDS impact score after 12 months of Control-IQ use. Score range from 0 -10 with lower scores indicating better outcome. | 12 months |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | not mutually exclusive, not all participants answered. | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| OG003 | No Prior CGM Experience | Subjects have not used CGM in the 30 days prior to enrollment. t:slim X2 pump with Control-IQ technology: Real-world use |
| OG004 | HbA1c Greater Than or Equal to 8% | Subjects have an HbA1c greater than or equal to 8% in the 6 months prior to enrollment. t:slim X2 pump with Control-IQ technology: Real-world use |
| OG005 | HbA1c Less Than 8% | Subjects have an HbA1c of less than 8% in the 6 months prior to enrollment. t:slim X2 pump with Control-IQ technology: Real-world use |
| OG006 | Prior Pump User | Existing insulin pump user t:slim X2 pump with Control-IQ technology: Real-world use |
| OG007 | Prior CGM Experience | Subjects have used CGM in the 30 days prior to enrollment. t:slim X2 pump with Control-IQ technology: Real-world use |
|
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| Primary | Incidence Rates of Diabetic Ketoacidosis (DKA) | Overall incidence rate of events per 100 patient years | Posted | Mean | Standard Deviation | events per 100 patient years | 12 months |
|
|
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| Primary | Percent of Boluses Using the Auto Population Feature Resulting in Fewer Readings Less Than 70 mg/dL Than Those Not Using the Feature | Percent of boluses using the auto population feature resulting in at least one reading less than 70 mg/dL than those not using the feature, in every pre-bolus glucose range examined. | Posted | Number | percentage of boluses | 12 months |
|
|
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| Secondary | Percent Time in Range 70 - 180 mg/dL | CGM measured percent time in range 70 - 180 mg/dL during 12 months of Control-IQ use | Posted | Median | Inter-Quartile Range | percentage of time | 12 months |
|
|
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| Secondary | Percent Time Greater Than 180 mg/dL | CGM measured percent time greater than 180 mg/dL during 12 months of Control-IQ use | Posted | Median | Inter-Quartile Range | percentage of time | 12 months |
|
|
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| Secondary | Percent Time Greater Than 250 mg/dL | CGM measured percent time greater than 250 mg/dL during 12 months of Control-IQ use | Posted | Median | Inter-Quartile Range | percentage of time | 12 months |
|
|
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| Secondary | Percent Time Less Than 70 mg/dL | CGM measured percent time less than 70 mg/dL during 12 months of Control-IQ use | Posted | Median | Inter-Quartile Range | percentage of time | 12 months |
|
|
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| Secondary | Percent Time Less Than 54 mg/dL | CGM measured percent time less than 54 mg/dL during 12 months of Control-IQ use | Posted | Median | Inter-Quartile Range | percentage of time | 12 months |
|
|
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| Secondary | Diabetes Impact and Satisfaction Scale (DIDS), Satisfaction Score | DIDS satisfaction score after 12 months of Control-IQ use. Score range from 0-10 with higher scores indicating better outcome. | Posted | Median | Inter-Quartile Range | score on a scale | 12 months |
|
|
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| Secondary | Diabetes Impact and Satisfaction Scale (DIDS), Impact Score | DIDS impact score after 12 months of Control-IQ use. Score range from 0 -10 with lower scores indicating better outcome. | Posted | Median | Inter-Quartile Range | score on a scale | 12 months |
|
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| 1 |
| 3,061 |
| 14 |
| 3,061 |
| 0 |
| 3,061 |
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| Severe Hyperglycemia | Endocrine disorders | Systematic Assessment | Hyperglycemia without ketones or DKA, evaluated in medical facility. |
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| Death | Cardiac disorders | Systematic Assessment | Death secondary to complications of longstanding congenital heart disease, unrelated to blood sugar. |
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| Chest pain | Cardiac disorders | Systematic Assessment | Chest pain evaluated in emergency department unrelated to blood sugar. |
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| 181 to 250 mg/dL Correction Bolus Results within 5 hours after bolus (no CGM auto population) |
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| > 250 mg/dL Correction Bolus Results within 5 hours after bolus (with CGM auto population) |
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| > 250 mg/dL Correction Bolus Results within 5 hours after bolus (no CGM auto population) |
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| All (with CGM auto population) |
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| All (no CGM auto population) |
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