Diabetes Mellitus, Type 1
Conditions
Keywords
type 1 diabetes, Control-IQ Technology, automated insulin dosing, automated insulin delivery
Brief summary
The purpose of this study is to obtain preliminary safety and performance data on planned improvements to Control-IQ technology.
Detailed description
This feasibility study is a prospective, single arm, single center study with a run-in phase, followed by a 48-hour supervised phase, followed by a 4-week at home study with sequential interventions (new feature use). Approximately 30 subjects, both male and female, aged 14 and up, will participate in the study, using new features each week with the t:slim X2 insulin pump with Control-IQ technology. The first 5 subjects in the study will complete a 48 hour session with multiple challenges during use of Control-IQ technology 2.0, before moving on the outpatient portion of the trial.
Interventions
DEVICEControl-IQ technology 2.0
All subjects wearing the t:slim X2 insulin pump with Control-IQ technology 2.0, and wearing the Dexcom G6 sensor
Sponsors
Tandem Diabetes Care, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single arm, Single Center, Prospective Clinical Study
Eligibility
Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult and adolescent male and female subjects \>age 14 years * Clinical diagnosis of Type 1 diabetes for at least one year * Experienced Control-IQ technology user for ≥3 months. * Use of Control-IQ technology in closed-loop at least 80% of the 2-week time period before screening. * Not pregnant or planning a pregnancy during the time period of the study * Using only Humalog U-100 or Novolog U-100 insulin * ICR and ISF optimized per investigator judgement * CGM time in range (70-180 mg/dL) at least 50% on Control-IQ technology * Has current glucagon product to treat severe hypoglycemia (injectable or nasal) at home (will provide prescription if they do not have one) * Willing to: 1. Share Dexcom G6 CGM data with study staff and Tandem 2. Share t:connect data with Tandem 3. Eat meals with known carbohydrate amounts 4. Take meal boluses as directed (use of different options as scheduled and instructed) 5. Follow study Glycemic Treatment Guidelines for hypo and hyperglycemia 6. Keep food and exercise diary 7. Set accurate sleep schedule on pump 8. Exercise while using exercise activity in Control-IQ technology at least twice weekly 9. Complete questionnaires before and after using investigational device 10. Sign an informed consent form * Willingness to use the Dexcom G6 app on their personal phone throughout the study, and share real time CGM information with a local contact and study staff * Availability of a local contact who has access to the study participant, knows their whereabouts, and agrees to be promptly available if contacted by study staff. If the subject lives alone, the local contact must live within 30 minutes and have access to the subject overnight.
Exclusion criteria
* Diabetic ketoacidosis (DKA) in the past 6 months * Severe hypoglycemia (needing assistance) in the past 6 months * Inpatient psychiatric treatment in the past 6 months * History of drug abuse (defined as any illicit drug use) or history of alcohol abuse prior to screening or is unwilling to agree to abstain from illicit drugs throughout the study * History of heart, lung or kidney disease determined by the investigator to interfere with the study * Use of glucocorticoids, beta blockers or other medications determined by investigator to interfere with the study * Use of long-acting insulin or any non-insulin glucose lowering agents (i.e. SGLT-2 inhibitor) other than metformin * Use of Afrezza during the study period * Febrile illness within 3 days of the start of the study * Subject is pregnant or lactating or intending to become pregnant before or during participation in this study * For subjects \>50 years old or with diabetes duration \>20 years who will be exercising as part of the 48 hour study, abnormal electrocardiogram consistent with increased risk of arrhythmia, ischemia, or prolonged QTc interval (\> 450 ms) * Significant chronic kidney disease (eGFR \< 60) or hemodialysis * Significant liver disease * History of adrenal insufficiency * History of abnormal TSH consistent with hypothyroidism or hyperthyroidism that is not appropriately treated
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Percent Time Less Than 54 mg/dL | Data collected over 1 week for each intervention, up to 5 weeks | CGM overall percent time less than 54 mg/dL, with different feature use of the pump each week. |
| Severe Hypoglycemia | Data collected over 1 week for each intervention, up to 5 weeks | Number of severe hypoglycemia events (with cognitive impairment such that assistance of another individual is needed for treatment), with different feature use of the pump each week. |
| Diabetic Ketoacidosis | Data collected over 1 week for each intervention, up to 5 weeks | Number of Diabetic Ketoacidosis events with different feature use of the pump each week. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Time <70 mg/dL | Data collected over 1 week for each intervention, up to 5 weeks | CGM percent time \<70 mg/dL, with different feature use of the pump each week. |
| Percent Time 70-140 mg/dL | Data collected over 1 week for each intervention, up to 5 weeks | CGM percent time 70-140 mg/dL, with different feature use of the pump each week. |
| Percent Time 70-180 mg/dL | Data collected over 1 week for each intervention, up to 5 weeks | CGM percent time 70-180 mg/dL, with different feature use of the pump each week. |
| Percent Time >180 mg/dL | Data collected over 1 week for each intervention, up to 5 weeks | CGM percent time \>180 mg/dL, with different feature use of the pump each week. |
| Percent Time >250 mg/dL | Data collected over 1 week for each intervention, up to 5 weeks | CGM percent time \>250 mg/dL, with different feature use of the pump each week. |
| Median of Mean Glucose (mg/dL) | Data collected over 1 week for each intervention, up to 5 weeks | Median of individual participants CGM Mean Glucose values (mg/dL), with different feature use of the pump each week. |
Countries
United States
Contacts
STUDY_CHAIRJordan E Pinsker, MD
Tandem Diabetes Care, Inc.
Participant flow
Recruitment details
33 participants signed the consent form, and therefore were considered enrolled. 33 local contacts were also consented. No baseline information was collected for local contacts.
Pre-assignment details
2 screen failures, and 1 additional participant dropped out immediately after the screening visit, along with their local contacts.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 7 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 23 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 28 Participants |
| Region of Enrollment United States | 30 Participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 1 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
None listed