Diabetes Mellitus, Type 1
Conditions
Keywords
type 1 diabetes, T1D, Tandem, t:slim X2, automated insulin delivery
Brief summary
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.
Detailed description
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.
Interventions
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.
Sponsors
Tandem Diabetes Care, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years old * Diagnosis of type 1 diabetes for at least 1 year * Current Control-IQ user, having been prescribed Control-IQ for at least 3 months * HbA1c ≤10%, recorded in the last 3 months * Investigator has confidence that the participant can successfully operate all study devices and is capable of adhering to the protocol, including performing the weekend hotel observed setting portion of the study. * Willing to use only aspart (novorapid) or lispro (humalog) insulin with the study pump, with no use of long-acting basal insulin injections, or inhaled insulin with the study pump.
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 1. A negative pregnancy test will be required for all females of child-bearing potential 2. Counseling on appropriate birth control options will be provided to all females of child-bearing potential * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With One or More Severe Hypoglycemia Events | Control-IQ Run-in Period (7 days), Tandem Freedom (3 days) | Number of Participants with One or More Severe Hypoglycemia Events (with cognitive impairment such that assistance of another individual is needed for treatment) |
| Number of Participants With One or More Diabetic Ketoacidosis Events | Control-IQ Run-in Period (7 days), Tandem Freedom (3 days) | Number of Participants with One or More Diabetic Ketoacidosis events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Time <54 mg/dL | Control-IQ Run-in Period (7 days), Tandem Freedom (3 days) | CGM measured percent time \<54 mg/dL |
| Percent Time <70 mg/dL | Control-IQ Run-in Period (7 days), Tandem Freedom (3 days) | CGM measured percent time \<70 mg/dL |
| Percent Time in Range 70 - 180 mg/dL | Control-IQ Run-in Period (7 days), Tandem Freedom (3 days) | CGM measured percent time in range 70 - 180 mg/dL |
| Percent Time in Range > 180 mg/dL | Control-IQ Run-in Period (7 days), Tandem Freedom (3 days) | CGM measured percent time in range \> 180 mg/dL |
| Percent Time in Range > 250 mg/dL | Control-IQ Run-in Period (7 days), Tandem Freedom (3 days) | CGM measured percent time in range \> 250 mg/dL |
| Percent Time in Range 70 - 140 mg/dL | Control-IQ Run-in Period (7 days), Tandem Freedom (3 days) | CGM measured percent time in range 70 - 140 mg/dL |
| Median of Mean Glucose (mg/dL) | Control-IQ Run-in Period (7 days), Tandem Freedom (3 days) | Median of each participant's mean glucose values (mg/dL) |
| Glucose Coefficient of Variation (%) | Control-IQ Run-in Period (7 days), Tandem Freedom (3 days) | CGM measured Coefficient of Variation (%) |
| Glucose Standard Deviation (mg/dL) | Control-IQ Run-in Period (7 days), Tandem Freedom (3 days) | CGM measured Standard Deviation (mg/dL) |
Countries
New Zealand
Contacts
STUDY_DIRECTORJordan Pinsker, MD
Tandem Diabetes Care, Inc.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 38.6 years STANDARD_DEVIATION 19.6 |
| Race/Ethnicity, Customized Dutch | 1 Participants |
| Race/Ethnicity, Customized Maori | 1 Participants |
| Race/Ethnicity, Customized New Zealand European | 8 Participants |
| Region of Enrollment New Zealand | 10 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 1 / 10 | 1 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
None listed