Type1diabetes
Conditions
Brief summary
The purpose of this study is to collect clinical data to support a 7-day wear of the Extended Wear Infusion Set (EWIS). Participants will be asked to: 1. Wear the EWIS for up to 7 consecutive days for 12 consecutive wear periods 2. Perform blood glucose and ketone measurements if continuous glucose meter is ≥250mg/dL for one hour
Detailed description
This is a multi-center, single-arm, prospective study of an extended wear infusion set in adults with Type 1 diabetes using a Tandem t:slim X2 insulin pump with Control-IQ technology with continuous Glucose Monitoring (CGM). Up to 300 participants across the United States age 18-80 will be enrolled in up to 20 investigational centers. Participants will change insulin cartridge every 48 to 72 hours as recommended by their health care provider. Participants will be expected to participate in the study for approximately 12-16 weeks.
Interventions
DEVICESteadiSet Extended Wear Infusion Set
Each participant will be given 12 Extended Wear Infusion Sets to wear over 12 wear periods up to 168 hours each.
Sponsors
Jaeb Center for Health Research
Tandem Diabetes Care, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Device Extended Wear Infusion Set Each participant will wear each extended wear infusion set for up to 168 hours for 12 sequential wear periods.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Inclusion Criteria: 1. Age 18 to 80 years old inclusive 2. Generally in good health, as determined by the investigator 3. Living in the United States with no plans to move outside the United States during the study 4. Diagnosis of T1D for at least 12 months 5. Minimum of 6 months of insulin pump experience and at least 3 months of current experience with a Tandem pump 6. Using Tandem t:slim X2 insulin pump with Control-IQ technology for a minimum of 1 month at the time of enrollment 7. Minimum of 14 days of Control-IQ data immediately preceding screening that demonstrate pump use compliance, including at least 85% of time with Control-IQ technology active 8. HbA1c \<9.0% in the last 6 months. 9. Willing to implement and adhere to pump alert/alarm settings on a study-provided pump as instructed during the study 10. Willing to wear each investigational infusion set for up to 7 days during each of the 12 consecutive wear periods in the study 11. Willing to perform blood ketone and blood glucose (fingerstick) measurements as directed using provided ketone and blood glucose meters and strips 12. Access to internet for required periodic uploads of study device data 13. BMI in the range 18-35 kg/m2, both inclusive 14. Currently using one of the following insulins with no expectation of a need to change insulin type during the study: 1. Humalog™\* (insulin lispro) 2. NovoLog™\* (insulin aspart) 15. Using Humalog™ insulin lispro or NovoLog™ insulin aspart for a minimum of 1 month at the time of enrollment 16. Willing to change insulin cartridge every 48-72 hours, as recommended by patient's healthcare provider during the study 17. Has routine access to a smart phone e.g., ability to receive text messages 18. Has the ability to understand and comply with protocol procedures and to provide informed consent (i.e., English proficient in both verbal and written communication)
Exclusion criteria
1. 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) 2. Female subject is pregnant, planning to become pregnant, or not using adequate method of contraception 3. Episodes of severe hypoglycemia in the last 6 months resulting in: 1. Medical Assistance (i.e., paramedics, hospital evaluation or hospitalization) 2. Loss of consciousness 3. Seizures 4. One or more episodes of diabetic ketoacidosis (DKA) in the last 6 months requiring hospitalization 5. Currently on a ketogenic or low-carbohydrate diet of less than 60 grams of carbohydrates per day, or intending to begin one during the study period 6. Known cardiovascular disease considered to be clinically relevant by the investigator 7. Known history of any of the following conditions: 1. Cushing's Disease 2. Pancreatic islet cell tumor 3. Insulinoma 4. Lipodystrophy 5. Extensive lipohypertrophy, as assessed by the investigator 8. Currently undergoing treatment with: 1. Systemic oral or intravenous corticosteroids (current or within the last 8 weeks from screening), 2. Thyroid hormones, unless use has been stable during the past 3 months 9. Significant history of any of the following, that in the opinion of the investigator would compromise safety or successful study participation: 1. Alcoholism 2. Drug abuse 10. Significant acute or chronic illness, that in the opinion of the investigator might interfere with safety or integrity of study results 11. Current participation in another clinical drug or device study 12. Immediate family member (spouse, biological or legal guardian, child, sibling, parent) who is a study site personnel directly affiliated with this study or who is an employee of Capillary Biomedical
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 7 Day Survival of Infusion Set for Primary Outcome Measure - Humalog | 12 weeks | 7-day infusion set survival for primary outcome reasons as defined in the protocol (Hyperglycemia and failure to respond to boluses, Hyperglycemia with ketones \>1.0 mmol/L, or Investigator advised), for participants using Humalog. |
| 7 Day Survival of Infusion Set for Primary Outcome Measure - Novolog | 12 weeks | 7-day infusion set survival for primary outcome reasons as defined in the protocol (Hyperglycemia and failure to respond to boluses, Hyperglycemia with ketones \>1.0 mmol/L, or Investigator advised), for participants using Novolog. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SteadiSet Extended Wear Infusion Set - Humalog Each participant will be asked to wear the Investigational Extended Wear Infusion Set for up to 168 hours for 12 consecutive wear periods with the Tandem t:slim X2 insulin pump with Control-IQ technology, and wearing the Dexcom G6 or G7 sensor.
Approximately half of the participants in the study were using Humalog insulin. | 128 |
| SteaduSet Extended Wear Infusion Set - Novolog Each participant will be asked to wear the Investigational Extended Wear Infusion Set for up to 168 hours for 12 consecutive wear periods with the Tandem t:slim X2 insulin pump with Control-IQ technology, and wearing the Dexcom G6 or G7 sensor.
Approximately half of the participants in the study were using Novolog insulin. | 132 |
| Total | 260 |
Baseline characteristics
| Characteristic | SteadiSet Extended Wear Infusion Set - Humalog | Total | SteaduSet Extended Wear Infusion Set - Novolog |
|---|---|---|---|
| Age, Continuous | 40.9 years STANDARD_DEVIATION 16 | 43.9 years STANDARD_DEVIATION 17.3 | 46.8 years STANDARD_DEVIATION 18 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 11 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 124 Participants | 249 Participants | 125 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 7 Participants | 9 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 6 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 115 Participants | 240 Participants | 125 Participants |
| Region of Enrollment United States | 128 participants | 260 participants | 132 participants |
| Sex: Female, Male Female | 83 Participants | 150 Participants | 67 Participants |
| Sex: Female, Male Male | 45 Participants | 110 Participants | 65 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 128 | 0 / 132 |
| other Total, other adverse events | 14 / 128 | 29 / 132 |
| serious Total, serious adverse events | 0 / 128 | 1 / 132 |
Outcome results
Primary
7 Day Survival of Infusion Set for Primary Outcome Measure - Humalog
7-day infusion set survival for primary outcome reasons as defined in the protocol (Hyperglycemia and failure to respond to boluses, Hyperglycemia with ketones \>1.0 mmol/L, or Investigator advised), for participants using Humalog.
Time frame: 12 weeks
Population: To be considered for analysis in the primary outcome, participants had to have successfully inserted at least 6 sets per the study protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SteadiSet Extended Wear Infusion Set - Humalog | 7 Day Survival of Infusion Set for Primary Outcome Measure - Humalog | 95 percentage of infusion set wears | Standard Error 0.7 |
Comparison: Ninety-five percent confidence intervals for the 7-day survival rates and p-values for the survival probabilities being greater than 75% were calculated with a bootstrap to account for the correlated data from having each participant wear multiple infusion sets.p-value: <0.00195% CI: [94, 97]Bootstrapping Kaplan-Meier estimates
Primary
7 Day Survival of Infusion Set for Primary Outcome Measure - Novolog
7-day infusion set survival for primary outcome reasons as defined in the protocol (Hyperglycemia and failure to respond to boluses, Hyperglycemia with ketones \>1.0 mmol/L, or Investigator advised), for participants using Novolog.
Time frame: 12 weeks
Population: To be considered for analysis in the primary outcome, participants had to have successfully inserted at least 6 sets per the study protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SteadiSet Extended Wear Infusion Set - Humalog | 7 Day Survival of Infusion Set for Primary Outcome Measure - Novolog | 95 percentage of infusion set wears | Standard Error 0.8 |
Comparison: Ninety-five percent confidence intervals for the 7-day survival rates and p-values for the survival probabilities being greater than 75% were calculated with a bootstrap to account for the correlated data from having each participant wear multiple infusion sets.p-value: <0.00195% CI: [93, 96]Bootstrapping Kaplan-Meier estimates