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A prospective, single-arm study of 13 weeks of home use of the t:slim X2 insulin pump with Control-IQ technology in individuals with type 1 diabetes who will plan to use at least one basal rate > 3 units/hr.
The objectives of the study are to assess safety and explore glycemic outcomes with use of an automated insulin dosing (AID) system (t:slim X2 insulin pump with Control-IQ technology v1.5) in adults with type 1 diabetes who will plan to use at least one basal rate > 3 units/hr. Up to 60 participants may be recruited.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| t:slim X2 insulin pump with Control-IQ technology | Experimental | Adults with type 1 diabetes will use the t:slim X2 insulin pump with Control-IQ technology 1.5 for 3-months of outpatient use. Meal and exercise challenges will be performed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| t:slim X2 insulin pump with Control-IQ technology 1.5 | Device | t:slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 CGM. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Severe Hypoglycemic Events | Number of severe hypoglycemia events (with cognitive impairment such that assistance of another individual is needed for treatment) during the entire study period | 3 months |
| Number of Diabetic Ketoacidosis Events | Number of diabetic ketoacidosis events during the entire study period | 3 months |
| Unanticipated Adverse Device Effects | Number of unanticipated adverse device effects during the entire study period | 3 months |
| Other Serious Adverse Events | Number of serious adverse events during the entire study period | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| CGM Time <54 mg/dL Overall | Percent time CGM glucose <54 mg/dL overall | 3 months |
| CGM Time <54 mg/dL Daytime Only | Percent time CGM glucose <54 mg/dL daytime only (06:00 - 24:00) |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin A1c | Change in Hemoglobin A1c from baseline | 3 months |
| CGM Time in Range 70-180 mg/dL Overall | Percent time CGM glucose in range 70-180 mg/dl overall |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jordan Pinsker, MD | Tandem Diabetes Care | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barbara Davis Center | Aurora | Colorado | 80045 | United States | ||
| Rocky Mountain Diabetes Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38439656 | Result | Carlson AL, Graham TE, Akturk HK, Liljenquist DR, Bergenstal RM, Sulik B, Shah VN, Sulik M, Zhao P, Briggs P, Sassan-Katchalski R, Pinsker JE. Control-IQ Technology Use in Individuals With High Insulin Requirements: Results From the Multicenter Higher-IQ Trial. J Diabetes Sci Technol. 2024 Nov;18(6):1288-1292. doi: 10.1177/19322968241234072. Epub 2024 Mar 5. |
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| ID | Title | Description |
|---|---|---|
| FG000 | t:Slim X2 Insulin Pump With Control-IQ Technology | Adults with type 1 diabetes will use the t:slim X2 insulin pump with Control-IQ technology 1.5 for 3-months of outpatient use. Meal and exercise challenges will be performed. t:slim X2 insulin pump with Control-IQ technology 1.5: t:slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 CGM. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
adults with type 1 diabetes (T1D) who planned to use at least one basal rate > 3 units/hour
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| ID | Title | Description |
|---|---|---|
| BG000 | t:Slim X2 Insulin Pump With Control-IQ Technology | Adults with type 1 diabetes will use the t:slim X2 insulin pump with Control-IQ technology 1.5 for 3-months of outpatient use. Meal and exercise challenges will be performed. t:slim X2 insulin pump with Control-IQ technology 1.5: t:slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 CGM. |
| 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 | Number of Severe Hypoglycemic Events | Number of severe hypoglycemia events (with cognitive impairment such that assistance of another individual is needed for treatment) during the entire study period | Posted | Number | events | 3 months |
|
|
13 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 | t:Slim X2 Insulin Pump With Control-IQ Technology | Adults with type 1 diabetes will use the t:slim X2 insulin pump with Control-IQ technology 1.5 for 3-months of outpatient use. Meal and exercise challenges will be performed. t:slim X2 insulin pump with Control-IQ technology 1.5: t:slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 CGM. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| New onset atrial fibrillation | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Otitis media | Ear and labyrinth disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Supervisor, Clinical Operations | Tandem Diabetes Care | (858) 366-6900 | 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 | Mar 21, 2022 | Dec 11, 2023 | 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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| 3 months |
| CGM Time <54 mg/dL Nighttime Only | Percent time CGM glucose <54 mg/dL nighttime only (00:00 - 06:00) | 3 months |
| CGM Time <70 mg/dL Overall | Percent time CGM glucose <70 mg/dL overall | 3 months |
| CGM Time <70 mg/dL Daytime Only | Percent time CGM glucose <70 mg/dL daytime only (06:00 - 24:00) | 3 months |
| CGM Time <70 mg/dL Nighttime Only | Percent time CGM glucose <70 mg/dL nighttime only (00:00 - 06:00) | 3 months |
| 3 months |
| CGM Time in Range 70-180 mg/dL Daytime Only | Percent time CGM glucose in range 70-180 mg/dl daytime only (06:00 - 24:00) | 3 months |
| CGM Time in Range 70-180 mg/dL Nighttime Only | Percent time CGM glucose in range 70-180 mg/dl nighttime only (00:00 - 06:00) | 3 months |
| CGM Time >180 mg/dL Overall | Percent time CGM glucose> 180 mg/dL overall | 3 months |
| CGM Time >180 mg/dL Daytime Only | Percent time CGM glucose> 180 mg/dL daytime only (06:00 - 24:00) | 3 months |
| CGM Time >180 mg/dL Nighttime Only | Percent time CGM glucose> 180 mg/dL nighttime only (00:00 - 06:00) | 3 months |
| CGM Time >250 mg/dL Overall | Percent time CGM glucose >250 mg/dL overall | 3 months |
| CGM Time >250 mg/dL Daytime Only | Percent time CGM glucose >250 mg/dL daytime only (06:00 - 24:00) | 3 months |
| CGM Time >250 mg/dL Nighttime Only | Percent time CGM glucose >250 mg/dL nighttime only (00:00 - 06:00) | 3 months |
| CGM Time in Range 70-140 mg/dL Overall | Percent time CGM glucose in range 70-140 mg/dl overall | 3 months |
| CGM Time in Range 70-140 mg/dL Daytime Only | Percent time CGM glucose in range 70-140 mg/dl daytime only (06:00 - 24:00) | 3 months |
| CGM Time in Range 70-140 mg/dL Nighttime Only | Percent time CGM glucose in range 70-140 mg/dl nighttime only (00:00 - 06:00) | 3 months |
| CGM Mean Glucose mg/dL Overall | CGM-measured mean glucose (mg/dL) overall | 3 months |
| CGM Mean Glucose mg/dL Daytime Only | CGM-measured mean glucose (mg/dL) daytime only (06:00 - 24:00) | 3 months |
| CGM Mean Glucose mg/dL Nighttime Only | CGM-measured mean glucose (mg/dL) nighttime only (00:00 - 06:00) | 3 months |
| Coefficient of Variation Overall | CGM measured glucose variability measured with the coefficient of variation overall | 3 months |
| Coefficient of Variation Daytime Only | CGM measured glucose variability measured with the coefficient of variation daytime only (06:00 - 24:00) | 3 months |
| Coefficient of Variation Nighttime Only | CGM measured glucose variability measured with the coefficient of variation nighttime only (00:00 - 06:00) | 3 months |
| Standard Deviation of Glucose, Overall | CGM measured standard deviation of glucose (mg/dL) overall | 3 months |
| Standard Deviation of Glucose, Daytime | CGM measured standard deviation of glucose (mg/dL), daytime only (06:00 - 24:00) | 3 months |
| Standard Deviation of Glucose, Nighttime Only | CGM measured standard deviation of glucose (mg/dL), nighttime only (00:00 - 06:00) | 3 months |
| Idaho Falls |
| Idaho |
| 83404 |
| United States |
| International Diabetes Center | Minneapolis | Minnesota | 55416 | United States |
| Diabetes & Endocrine Treatment Specialists | Sandy City | Utah | 84093 | United States |
| Participants |
|
| Age, Continuous | Median | Full Range | 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 |
|
| Socio-economic factors (income) | Number | participants |
|
| Socio-economic factors (education) | Number | participants |
|
| Duration of Diabetes | Mean | Standard Deviation | years |
|
| HbA1c at Control-IQ Start | Mean | Standard Deviation | percentage of glycated hemoglobin |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| Total daily insulin | Mean | Standard Deviation | units/kg/day |
|
| Participants |
|
|
| Primary | Number of Diabetic Ketoacidosis Events | Number of diabetic ketoacidosis events during the entire study period | Posted | Number | events | 3 months |
|
|
|
| Primary | Unanticipated Adverse Device Effects | Number of unanticipated adverse device effects during the entire study period | Posted | Number | events | 3 months |
|
|
|
| Primary | Other Serious Adverse Events | Number of serious adverse events during the entire study period | Posted | Number | events | 3 months |
|
|
|
| Secondary | CGM Time <54 mg/dL Overall | Percent time CGM glucose <54 mg/dL overall | Posted | Mean | Standard Deviation | percentage of time | 3 months |
|
|
|
| Secondary | CGM Time <54 mg/dL Daytime Only | Percent time CGM glucose <54 mg/dL daytime only (06:00 - 24:00) | Posted | Mean | Standard Deviation | percentage of time | 3 months |
|
|
|
| Secondary | CGM Time <54 mg/dL Nighttime Only | Percent time CGM glucose <54 mg/dL nighttime only (00:00 - 06:00) | Posted | Mean | Standard Deviation | percentage of time | 3 months |
|
|
|
| Secondary | CGM Time <70 mg/dL Overall | Percent time CGM glucose <70 mg/dL overall | Posted | Mean | Standard Deviation | percentage of time | 3 months |
|
|
|
| Secondary | CGM Time <70 mg/dL Daytime Only | Percent time CGM glucose <70 mg/dL daytime only (06:00 - 24:00) | Posted | Mean | Standard Deviation | percentage of time | 3 months |
|
|
|
| Secondary | CGM Time <70 mg/dL Nighttime Only | Percent time CGM glucose <70 mg/dL nighttime only (00:00 - 06:00) | Posted | Mean | Standard Deviation | percentage of time | 3 months |
|
|
|
| Other Pre-specified | Hemoglobin A1c | Change in Hemoglobin A1c from baseline | Posted | Mean | Standard Deviation | percentage of glycated hemoglobin | 3 months |
|
|
|
|
| Other Pre-specified | CGM Time in Range 70-180 mg/dL Overall | Percent time CGM glucose in range 70-180 mg/dl overall | Posted | Mean | Standard Deviation | percentage of time | 3 months |
|
|
|
| Other Pre-specified | CGM Time in Range 70-180 mg/dL Daytime Only | Percent time CGM glucose in range 70-180 mg/dl daytime only (06:00 - 24:00) | Posted | Mean | Standard Deviation | percentage of time | 3 months |
|
|
|
| Other Pre-specified | CGM Time in Range 70-180 mg/dL Nighttime Only | Percent time CGM glucose in range 70-180 mg/dl nighttime only (00:00 - 06:00) | Posted | Mean | Standard Deviation | percentage of time | 3 months |
|
|
|
| Other Pre-specified | CGM Time >180 mg/dL Overall | Percent time CGM glucose> 180 mg/dL overall | Posted | Mean | Standard Deviation | percentage of time | 3 months |
|
|
|
| Other Pre-specified | CGM Time >180 mg/dL Daytime Only | Percent time CGM glucose> 180 mg/dL daytime only (06:00 - 24:00) | Posted | Mean | Standard Deviation | percentage of time | 3 months |
|
|
|
| Other Pre-specified | CGM Time >180 mg/dL Nighttime Only | Percent time CGM glucose> 180 mg/dL nighttime only (00:00 - 06:00) | Posted | Mean | Standard Deviation | percentage of time | 3 months |
|
|
|
| Other Pre-specified | CGM Time >250 mg/dL Overall | Percent time CGM glucose >250 mg/dL overall | Posted | Mean | Standard Deviation | percentage of time | 3 months |
|
|
|
| Other Pre-specified | CGM Time >250 mg/dL Daytime Only | Percent time CGM glucose >250 mg/dL daytime only (06:00 - 24:00) | Posted | Mean | Standard Deviation | percentage of time | 3 months |
|
|
|
| Other Pre-specified | CGM Time >250 mg/dL Nighttime Only | Percent time CGM glucose >250 mg/dL nighttime only (00:00 - 06:00) | Posted | Mean | Standard Deviation | percentage of time | 3 months |
|
|
|
| Other Pre-specified | CGM Time in Range 70-140 mg/dL Overall | Percent time CGM glucose in range 70-140 mg/dl overall | Posted | Mean | Standard Deviation | percentage of time | 3 months |
|
|
|
| Other Pre-specified | CGM Time in Range 70-140 mg/dL Daytime Only | Percent time CGM glucose in range 70-140 mg/dl daytime only (06:00 - 24:00) | Posted | Mean | Standard Deviation | percentage of time | 3 months |
|
|
|
| Other Pre-specified | CGM Time in Range 70-140 mg/dL Nighttime Only | Percent time CGM glucose in range 70-140 mg/dl nighttime only (00:00 - 06:00) | Posted | Mean | Standard Deviation | percentage of time | 3 months |
|
|
|
| Other Pre-specified | CGM Mean Glucose mg/dL Overall | CGM-measured mean glucose (mg/dL) overall | Posted | Mean | Standard Deviation | mg/dL | 3 months |
|
|
|
| Other Pre-specified | CGM Mean Glucose mg/dL Daytime Only | CGM-measured mean glucose (mg/dL) daytime only (06:00 - 24:00) | Posted | Mean | Standard Deviation | mg/dL | 3 months |
|
|
|
| Other Pre-specified | CGM Mean Glucose mg/dL Nighttime Only | CGM-measured mean glucose (mg/dL) nighttime only (00:00 - 06:00) | Posted | Mean | Standard Deviation | mg/dL | 3 months |
|
|
|
| Other Pre-specified | Coefficient of Variation Overall | CGM measured glucose variability measured with the coefficient of variation overall | Posted | Mean | Standard Deviation | percentage of coefficient of variation | 3 months |
|
|
|
| Other Pre-specified | Coefficient of Variation Daytime Only | CGM measured glucose variability measured with the coefficient of variation daytime only (06:00 - 24:00) | Posted | Mean | Standard Deviation | percentage of coefficient of variation | 3 months |
|
|
|
| Other Pre-specified | Coefficient of Variation Nighttime Only | CGM measured glucose variability measured with the coefficient of variation nighttime only (00:00 - 06:00) | Posted | Mean | Standard Deviation | percentage of coefficient of variation | 3 months |
|
|
|
| Other Pre-specified | Standard Deviation of Glucose, Overall | CGM measured standard deviation of glucose (mg/dL) overall | Posted | Mean | Standard Deviation | mg/dL | 3 months |
|
|
|
| Other Pre-specified | Standard Deviation of Glucose, Daytime | CGM measured standard deviation of glucose (mg/dL), daytime only (06:00 - 24:00) | Posted | Mean | Standard Deviation | mg/dL | 3 months |
|
|
|
| Other Pre-specified | Standard Deviation of Glucose, Nighttime Only | CGM measured standard deviation of glucose (mg/dL), nighttime only (00:00 - 06:00) | Posted | Mean | Standard Deviation | mg/dL | 3 months |
|
|
|
| 0 |
| 34 |
| 1 |
| 34 |
| 19 |
| 34 |
| Tympanic membrane perforation | Ear and labyrinth disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Tooth fracture | Gastrointestinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Influenza like illness | General disorders | Systematic Assessment |
|
| Bronchitis | Infections and infestations | Systematic Assessment |
|
| COVID-19 | Infections and infestations | Systematic Assessment |
|
| Ear Infection | Infections and infestations | Systematic Assessment |
|
| Influenza | Infections and infestations | Systematic Assessment |
|
| Otitis Externa | Infections and infestations | Systematic Assessment |
|
| Pharyngitis streptococcal | Infections and infestations | Systematic Assessment |
|
| Tooth abscess | Infections and infestations | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
|
| Skin abrasion | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Ketonemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Dyslipidemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Ligament sprain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Stiff person syndrome | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Migraine | Nervous system disorders | Systematic Assessment |
|
| Chronic kidney disease | Renal and urinary disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Sleep apnea syndrome | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Hypertension | Vascular disorders | Systematic Assessment |
|
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |