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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 one week run-in, then will use Tandem Freedom in a supervised hotel setting.
After a one 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 4 nights: 1 day with boluses, and 3 days without boluses, in a supervised hotel setting. Participants will perform 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 will use the Tandem Freedom system for one partial day with user initiated mealtime insulin boluses and three days without user initiated mealtime insulin boluses in a supervised hotel setting. Participants will also perform exercise challenges. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| t:slim X2 insulin pump with Tandem Freedom Algorithm | Device | t:slim X2 insulin pump with Tandem Freedom System consists of the Tandem t:slim X2 insulin pump and the Freedom algorithm embedded in the pump. Participants will also use the Dexcom G6 continuous glucose monitoring system. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With One or More Severe Hypoglycemia Events | Number of Participants with One or More Severe Hypoglycemia Events (with cognitive impairment such that assistance of another individual is needed for treatment) | Control-IQ Run-in Period (7 days), Tandem Freedom (3 days) |
| Number of Participants With One or More Diabetic Ketoacidosis Events | Number of Participants with One or More Diabetic Ketoacidosis events | Control-IQ Run-in Period (7 days), Tandem Freedom (3 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Time <54 mg/dL | CGM measured percent time <54 mg/dL | Control-IQ Run-in Period (7 days), Tandem Freedom (3 days) |
| 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, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Otago | Christchurch | 8140 | New Zealand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41236930 | Result | Wilkinson TM, de Bock MI, Meier R, Hurd S, Sasson-Katchalski R, Trahan A, Rueda JR, Sherer N, Stephens M, Meyer B, Gantulga D, Rackow S, D'Souza EW, Briggs P, Corbett JP, Ulrich TR, Pinsker JE. Fully Closed-Loop Insulin Delivery with High-Carbohydrate and High-Fat Meals Using the Tandem Freedom System. J Diabetes Sci Technol. 2025 Nov 14:19322968251389966. doi: 10.1177/19322968251389966. Online ahead of print. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tandem Freedom | After a one week run-in period with Control-IQ technology, participants will use the Tandem Freedom system for one partial day with user initiated mealtime insulin boluses and three days without user initiated mealtime insulin boluses in a supervised hotel setting. Participants will also perform exercise challenges. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tandem Freedom | After a one week run-in period with Control-IQ technology, participants will use the Tandem Freedom system for one partial day with user initiated mealtime insulin boluses and three days without user initiated mealtime insulin boluses in a supervised hotel setting. Participants will also perform exercise challenges. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Participants With One or More Severe Hypoglycemia Events | Number of Participants with One or More Severe Hypoglycemia Events (with cognitive impairment such that assistance of another individual is needed for treatment) | Posted | Count of Participants | Participants | Control-IQ Run-in Period (7 days), Tandem Freedom (3 days) |
|
|
10 days
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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 | Run-in Period | One week run-in period with Control-IQ technology. | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Superficial burn | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment | Left forearm superficial burn while cooking |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr. Clinical Research Associate I | 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 | Nov 20, 2024 | Sep 4, 2025 | 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 Period (7 days), Tandem Freedom (3 days) |
| Percent Time in Range 70 - 180 mg/dL | CGM measured percent time in range 70 - 180 mg/dL | Control-IQ Run-in Period (7 days), Tandem Freedom (3 days) |
| Percent Time in Range > 180 mg/dL | CGM measured percent time in range > 180 mg/dL | Control-IQ Run-in Period (7 days), Tandem Freedom (3 days) |
| Percent Time in Range > 250 mg/dL | CGM measured percent time in range > 250 mg/dL | Control-IQ Run-in Period (7 days), Tandem Freedom (3 days) |
| Percent Time in Range 70 - 140 mg/dL | CGM measured percent time in range 70 - 140 mg/dL | Control-IQ Run-in Period (7 days), Tandem Freedom (3 days) |
| Median of Mean Glucose (mg/dL) | Median of each participant's mean glucose values (mg/dL) | Control-IQ Run-in Period (7 days), Tandem Freedom (3 days) |
| Glucose Coefficient of Variation (%) | CGM measured Coefficient of Variation (%) | Control-IQ Run-in Period (7 days), Tandem Freedom (3 days) |
| Glucose Standard Deviation (mg/dL) | CGM measured Standard Deviation (mg/dL) | Control-IQ Run-in Period (7 days), Tandem Freedom (3 days) |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Counts |
|---|
| Participants |
|
|
| Primary | Number of Participants With One or More Diabetic Ketoacidosis Events | Number of Participants with One or More Diabetic Ketoacidosis events | Posted | Count of Participants | Participants | Control-IQ Run-in Period (7 days), Tandem Freedom (3 days) |
|
|
|
| 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 Period (7 days), Tandem Freedom (3 days) |
|
|
|
| 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 Period (7 days), Tandem Freedom (3 days) |
|
|
|
| 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 Period (7 days), Tandem Freedom (3 days) |
|
|
|
| Secondary | Percent Time in Range > 180 mg/dL | CGM measured percent time in range > 180 mg/dL | Posted | Median | Inter-Quartile Range | percentage of time | Control-IQ Run-in Period (7 days), Tandem Freedom (3 days) |
|
|
|
| Secondary | Percent Time in Range > 250 mg/dL | CGM measured percent time in range > 250 mg/dL | Posted | Median | Inter-Quartile Range | percentage of time | Control-IQ Run-in Period (7 days), Tandem Freedom (3 days) |
|
|
|
| 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 Period (7 days), Tandem Freedom (3 days) |
|
|
|
| Secondary | Median of Mean Glucose (mg/dL) | Median of each participant's mean glucose values (mg/dL) | Posted | Median | Inter-Quartile Range | Median of mean glucose values (mg/dL) | Control-IQ Run-in Period (7 days), Tandem Freedom (3 days) |
|
|
|
| Secondary | Glucose Coefficient of Variation (%) | CGM measured Coefficient of Variation (%) | Posted | Median | Inter-Quartile Range | Percentage of variation | Control-IQ Run-in Period (7 days), Tandem Freedom (3 days) |
|
|
|
| Secondary | Glucose Standard Deviation (mg/dL) | CGM measured Standard Deviation (mg/dL) | Posted | Median | Inter-Quartile Range | mg/dL | Control-IQ Run-in Period (7 days), Tandem Freedom (3 days) |
|
|
|
| 10 |
| 0 |
| 10 |
| 1 |
| 10 |
| EG001 | Tandem Freedom | Participants will use the Tandem Freedom system for one partial day with user initiated mealtime insulin boluses and three days without user initiated mealtime insulin boluses in a supervised hotel setting. Participants also performed exercise challenges. | 0 | 10 | 0 | 10 | 1 | 10 |
|
| Headache | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment | Headache |
|
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |