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| Name | Class |
|---|---|
| University of California, San Diego | OTHER |
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This 522 post-market surveillance study is a single-arm, decentralized prospective observational cohort study designed to collect safety data on Control-IQ technology v1.5 in children with type 1 diabetes ages 2 to <6 years old. Participants will use Control-IQ technology v1.5 for 12 months in the real-world setting.
The study will recruit participants age 2 to <6 years old who begin Control-IQ technology v1.5 use in the real-world setting, with a goal of a minimum of 120 completers at 12 months. All enrolled participants will be monitored from baseline through 12 months following the initiation of therapy with the Control-IQ 1.5 system. The primary endpoint is the risk of diabetic ketoacidosis (DKA) and severe hypoglycemia (SH) events. Secondary outcomes include CGM time in range measurements, and patient reported outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control-IQ Technology v1.5 | Real-world use of Control-IQ technology v1.5 for 12 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control-IQ Technology v1.5 | Device | Tandem t:slim X2 insulin pump or Tandem Mobi insulin pump with Control-IQ technology v1.5. Every month participants will receive a survey to complete assessments including any severe hypoglycemia or diabetic ketoacidosis events experienced since the prior assessment. Participants will also complete surveys related to patient reported outcomes at baseline, 6 months, and 12 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence Rates of Severe Hypoglycemia (SH) | Overall incidence rate of SH events per 100 patient years during 12 months of Control-IQ use | 12 months |
| Incidence Rates of Diabetic Ketoacidosis (DKA) | Overall incidence rate of DKA events per 100 patient years during 12 months of Control-IQ use | 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 >180 mg/dL during 12 months of Control-IQ use |
| Measure | Description | Time Frame |
|---|---|---|
| Diabetes Impact and Satisfaction Scale (DIDS), Satisfaction Score | DIDS satisfaction score at baseline, and after 6 and 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 |
Inclusion Criteria:
Exclusion Criteria:
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Enrollment in the study will be available to all individuals age 2 to <6 years of age at time of screening who start therapy with Control-IQ Technology v1.5.
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| Name | Affiliation | Role |
|---|---|---|
| Jordan Pinsker, MD | Chief Medical Officer, Tandem Diabetes Care | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tandem Diabetes Care | San Diego | California | 92130 | United States |
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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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| 12 months |
| Percent Time Greater Than 250 mg/dL | CGM measured percent time >250 mg/dL during 12 months of Control-IQ use | 12 months |
| Percent Time Less Than 70 mg/dL | CGM measured percent time <70 mg/dL during 12 months of Control-IQ use | 12 months |
| Percent Time Less Than 54 mg/dL | CGM measured percent time <54 mg/dL during 12 months of Control-IQ use | 12 months |
| Mean Glucose mg/dL | CGM measured mean glucose during 12 months of Control-IQ use | 12 months |
DIDS impact score at baseline, and after 6 and 12 months of Control-IQ use. Score range from 0 -10 with lower scores indicating better outcome. |
| 12 months |
| EQ-5D (inclusive of the Visual Analogue Scale (VAS)) | Questionnaire score at baseline, and after 6 and 12 months of Control-IQ use. | 12 months |
| Hypoglycemia Fear Survey - Parent for Young Children Version (HFS-P-YC) | Questionnaire score at baseline, and after 6 and 12 months of Control-IQ use. | 12 months |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |