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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1307-6267 | Other Identifier | ICTRP |
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This feasibility study is a prospective, single arm study evaluating the Tandem Freedom system in adults with type 1 diabetes. Existing Control-IQ technology users will use Control-IQ technology at home for a 1 week run-in, then will use Tandem Freedom in a supervised hotel setting.
After a 1 week Control-IQ run-in at home, 10 adults who are existing Control-IQ users with type 1 diabetes will use the Tandem Freedom System for 1 day with boluses, and 1 day without boluses, in a supervised hotel setting. Participants will perform meal and exercise challenges. The primary outcome is safety events. CGM time in ranges will also be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tandem Freedom | Experimental | After a one week run-in period with Control-IQ technology, participants used the Tandem Freedom system for one day with insulin boluses and one day without insulin boluses. Participants performed meal and exercise challenges in a supervised hotel setting. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| t:slim X2 insulin pump with Tandem Freedom Algorithm | Device | Participants will use the Tandem Freedom system for one day with insulin boluses and one day without insulin boluses. |
| Measure | Description | Time Frame |
|---|---|---|
| Severe Hypoglycemia Events | Number of severe hypoglycemia events (with cognitive impairment such that assistance of another individual is needed for treatment) | Control-IQ Run-in with boluses 7 days, day 8 freedom with meal bolus and day 9 freedom without meal bolus |
| Diabetic Ketoacidosis Events | Number of diabetic ketoacidosis events | Control-IQ Run-in with boluses 7 days, day 8 freedom with meal bolus and day 9 freedom without meal bolus |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Time <54 mg/dL | CGM measured percent time <54 mg/dL | Control-IQ Run-in with boluses 7 days, day 8 freedom with meal bolus and day 9 freedom without meal bolus |
| Percent Time <70 mg/dL | CGM measured percent time <70 mg/dL |
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Inclusion Criteria:
Exclusion Criteria:
More than 1 episode of diabetic ketoacidosis (DKA) in the past 6 months
More than 1 episode of severe hypoglycemia (needing assistance) in the past 6 months
Inpatient psychiatric treatment in the past 6 months
For Female: Currently pregnant or planning to become pregnant during the time period of study participation
Concurrent use of any non-insulin glucose-lowering agent, other than metformin (for example, GLP-1 agonists, Symlin, DPP-4 inhibitors, SGLT-2 inhibitors, sulfonylureas).
Hemophilia or any other bleeding disorder
Hemoglobinopathy
History of heart, liver, lung or kidney disease determined by investigator to interfere with the study
History of allergic reaction to Humalog or Novorapid
Use of any medications determined by investigator to interfere with study
Significant chronic kidney disease (which could impact CGM accuracy in investigator's judgment) or hemodialysis
Concurrent use of any medication that could interfere with the study CGM, such as hydroxyurea
History of adrenal insufficiency
History of abnormal TSH consistent with hypothyroidism or hyperthyroidism that is not appropriately treated
History of gastroparesis
A condition, which in the opinion of the investigator or designee, would put the participant or study at risk
Participation in another pharmaceutical or device trial at the time of enrollment or anticipated for during the time period of study participation
Employed by, or having immediate family members 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 |
|---|---|---|
| Jordan Pinsker, MD | Tandem Diabetes Care | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Otago | Christchurch | 8140 | New Zealand |
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Ten adults with type 1 diabetes (all existing Control-IQ users) were recruited for this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tandem Freedom | After a 1 week Control-IQ run-in, adults with type 1 diabetes will complete a supervised hotel study with the Tandem Freedom system 1 day with boluses, and 1 day without boluses, performing meal and exercise challenges. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
10 adults with type 1 diabetes, who were existing users of the t:slim X2 insulin pump with Control-IQ technology for at least 3 months
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| ID | Title | Description |
|---|---|---|
| BG000 | t:Slim X2 Insulin Pump With Tandem Freedom Algorithm | After a 1 week Control-IQ run-in, adults with type 1 diabetes will complete a supervised hotel study with the Tandem Freedom system 1 day with boluses, and 1 day without boluses, performing meal and exercise challenges. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Sex: Female, Male | 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 Hypoglycemia Events | Number of severe hypoglycemia events (with cognitive impairment such that assistance of another individual is needed for treatment) | Posted | Number | number of events | Control-IQ Run-in with boluses 7 days, day 8 freedom with meal bolus and day 9 freedom without meal bolus |
|
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9 days, to include a 7 day run-in with Control-IQ technology, followed by one day of Freedom with boluses and one day of Freedom without boluses.
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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 Tandem Freedom Algorithm | After a 1 week Control-IQ run-in, adults with type 1 diabetes will complete a supervised hotel study with the Tandem Freedom system 1 day with boluses, and 1 day without boluses, performing meal and exercise challenges. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperglycemia with ketosis, due to infusion set failure | Endocrine disorders | Systematic Assessment | While using Freedom with boluses, resolved with infusion set change. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Manager, Clinical Affairs | Tandem Diabetes Care | 8583666900 | 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 | Apr 30, 2024 | Oct 30, 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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| Control-IQ Run-in with boluses 7 days, day 8 freedom with meal bolus and day 9 freedom without meal bolus |
| Percent Time in Range 70 - 180 mg/dL | CGM measured percent time in range 70 - 180 mg/dL | Control-IQ Run-in with boluses 7 days, day 8 freedom with meal bolus and day 9 freedom without meal bolus |
| Percent Time in Range 70 - 140 mg/dL | CGM measured percent time in range 70 - 140 mg/dL | Control-IQ Run-in with boluses 7 days, day 8 freedom with meal bolus and day 9 freedom without meal bolus |
| Percent Time >180 mg/dL | CGM measured percent time >180 mg/dL | Control-IQ Run-in with boluses 7 days, day 8 freedom with meal bolus and day 9 freedom without meal bolus |
| Percent Time >250 mg/dL | CGM measured percent time >250mg/dL | Control-IQ Run-in with boluses 7 days, day 8 freedom with meal bolus and day 9 freedom without meal bolus |
| Mean Glucose (mg/dL) | CGM measured mean glucose (mg/dL) | Control-IQ Run-in with boluses 7 days, day 8 freedom with meal bolus and day 9 freedom without meal bolus |
| Glucose Coefficient of Variation (%) | CGM measured Coefficient of Variation (%) | Control-IQ Run-in with boluses 7 days, day 8 freedom with meal bolus and day 9 freedom without meal bolus |
| Glucose Standard Deviation (mg/dL) | CGM measured Standard Deviation (mg/dL) | Control-IQ Run-in with boluses 7 days, day 8 freedom with meal bolus and day 9 freedom without meal bolus |
| Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| HbA1c at Enrollment | Mean | Standard Deviation | percentage of glycated hemoglobin |
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| Total Daily Insulin Dose at Enrollment | Mean | Standard Deviation | units/day |
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| Duration of Diabetes | Mean | Standard Deviation | years |
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| BMI at Enrollment | Mean | Standard Deviation | kg/m^2 |
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| Number of DKA events in the last 6 months | Number | DKA events |
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| Number of severe hypoglycemic events (required assistance) in the last 6 months | Number | Severe Hypoglycemic Events |
|
| Age, Continuous | Mean | Standard Deviation | years |
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| Primary | Diabetic Ketoacidosis Events | Number of diabetic ketoacidosis events | Posted | Number | number of events | Control-IQ Run-in with boluses 7 days, day 8 freedom with meal bolus and day 9 freedom without meal bolus |
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| Secondary | Percent Time <54 mg/dL | CGM measured percent time <54 mg/dL | Posted | Median | Inter-Quartile Range | percentage of time | Control-IQ Run-in with boluses 7 days, day 8 freedom with meal bolus and day 9 freedom without meal bolus |
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| Secondary | Percent Time <70 mg/dL | CGM measured percent time <70 mg/dL | Posted | Median | Inter-Quartile Range | percentage of time | Control-IQ Run-in with boluses 7 days, day 8 freedom with meal bolus and day 9 freedom without meal bolus |
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| Secondary | Percent Time in Range 70 - 180 mg/dL | CGM measured percent time in range 70 - 180 mg/dL | Posted | Median | Inter-Quartile Range | percentage of time | Control-IQ Run-in with boluses 7 days, day 8 freedom with meal bolus and day 9 freedom without meal bolus |
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| Secondary | Percent Time in Range 70 - 140 mg/dL | CGM measured percent time in range 70 - 140 mg/dL | Posted | Median | Inter-Quartile Range | percentage of time | Control-IQ Run-in with boluses 7 days, day 8 freedom with meal bolus and day 9 freedom without meal bolus |
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| Secondary | Percent Time >180 mg/dL | CGM measured percent time >180 mg/dL | Posted | Median | Inter-Quartile Range | percentage of time | Control-IQ Run-in with boluses 7 days, day 8 freedom with meal bolus and day 9 freedom without meal bolus |
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| Secondary | Percent Time >250 mg/dL | CGM measured percent time >250mg/dL | Posted | Median | Inter-Quartile Range | percentage of time | Control-IQ Run-in with boluses 7 days, day 8 freedom with meal bolus and day 9 freedom without meal bolus |
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| Secondary | Mean Glucose (mg/dL) | CGM measured mean glucose (mg/dL) | Posted | Median | Inter-Quartile Range | mg/dL | Control-IQ Run-in with boluses 7 days, day 8 freedom with meal bolus and day 9 freedom without meal bolus |
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| Secondary | Glucose Coefficient of Variation (%) | CGM measured Coefficient of Variation (%) | Posted | Median | Inter-Quartile Range | percentage | Control-IQ Run-in with boluses 7 days, day 8 freedom with meal bolus and day 9 freedom without meal bolus |
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| Secondary | Glucose Standard Deviation (mg/dL) | CGM measured Standard Deviation (mg/dL) | Posted | Median | Inter-Quartile Range | mg/dL | Control-IQ Run-in with boluses 7 days, day 8 freedom with meal bolus and day 9 freedom without meal bolus |
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| 0 |
| 10 |
| 0 |
| 10 |
| 1 |
| 10 |
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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