Diabetes
Conditions
Brief summary
The purpose of this study is to collect confirmatory clinical data to support 6 or 7 days wear of EWIS (Extended Wear Infusion Set).
Detailed description
This study is a multi-center, non-randomized, prospective single arm study with Type 1 patients with diabetes on insulin pump therapy with Continuous Glucose Monitoring (CGM). A total of up to 300 subjects age 18-80 will be enrolled at up to 20 investigational centers in the US. Each subject will wear their own MiniMed™ 670G insulin system. Each subject will be given 12 infusion sets to wear (each infusion set for at least 174 hours, or until infusion set failure if this occurs before 174 hours). Subjects will change insulin reservoirs at least every 174 hours. The time of infusion set insertion will be taken from Daily Log. Subjects can expect to participate for approximately 12-16 weeks.
Interventions
DEVICEExtended Infusion Set
Each subject is asked to wear each Extended Wear Infusion Set for at least 174 hours.
Sponsors
Medtronic Diabetes
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Subject is age 18 - 80 years at the time of screening 2. Subject has type 1 diabetes for more than one year Study specific inclusion criteria 3. Subject is on the MiniMed™ 670G insulin pump therapy within 1 year prior to screening and willing to utilize Auto Mode and CGM with Guardian™ Sensor (3) during the study. 4. Subject is willing and able to perform study procedures as per investigator discretion 5. Subject is willing to take one of the following insulins and can financially support the use of either of the 2 insulin preparations throughout the course of the study (i.e. co-payments for insulin with insurance or able to pay full amount): 1. Humalog™\* (insulin lispro injection) 2. NovoLog™\* (insulin aspart)
Exclusion criteria
1. Subject is actively participating in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or investigational study device in the last 2 weeks. 2. Subject is female and has a positive pregnancy screening test 3. Subject is female of child bearing age and who is sexually active should be excluded if she is not using a form of contraception deemed reliable by investigator 4. Subject is female and plans to become pregnant during the course of the study 5. Subject has Glycosylated hemoglobin (HbA1c) \> 8.5 % at time of screening. Note: All HbA1c blood specimens will be sent to and tested by a NGSP certified Central Laboratory. HbA1c testing must follow National Glycohemoglobin Standardization Program (NGSP) standards. 6. Subject has had a history of 1 or more episodes of severe hypoglycemia, which resulted in any the following during the 6 months prior to screening 1. Medical assistance (i.e. Paramedics, Emergency Room \[ER\] or Hospitalization) 2. Coma 3. Seizures 7. Subject has taken any oral, injectable, or IV glucocorticoids within 8 weeks from time of screening visit, or plans to take any oral, injectable, or IV glucocorticoids during the course of the study. 8. Subject is unable to tolerate tape adhesive in the area of infusion set 9. Subject has any unresolved adverse skin condition in the area of infusion set placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection) 10. Subject has infection in the area of infusion set placement at time of screening 11. Subject has had Diabetic Ketoacidosis (DKA) in the 12 months prior to screening visit. 12. Subject is currently abusing illicit drugs 13. Subject is currently abusing alcohol 14. Subject is on dialysis (for renal failure) 15. Subject has history of adrenal disorder 16. Subject has a history of inpatient psychiatric treatment in the past 6 months prior to screening 17. Subject has any condition that the Investigator believes would interfere with study participation 18. Subject has a history of visual impairment which would not allow subject to participate in the study and perform all study procedures safely, as determined by the investigator 19. Subject has a sickle cell disease, hemoglobinopathy; or has received red blood cell transfusion or erythropoietin within 3 months prior to time of screening 20. Subject plans to receive red blood cell transfusion or erythropoietin over the course of study participation 21. Subject is using pramlintide (Symlin), SGLT2 inhibitors, GLP agonists, biguanides, DPP-4 inhibitors or sulfonylureas more than 2 weeks from time of screening 22. Subject has been diagnosed with chronic kidney disease requiring dialysis or resulting in chronic anemia 23. Subject has history of cardiovascular disease defined as any ischemic related event or clinically significant arrythmia. 24. Subject has hypothyroidism and has out of reference range thyroid-stimulating hormone (TSH) on screening visit (prior labs in the last 3 months are sufficient). Subject may repeat TSH draw to verify eligibility if not in range
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Humalog Subjects - Rate of Infusion Set Failure at the End of Day 6 | 144 hours | Evaluate rate of infusion set failure due to unexplained hyperglycemia (i.e. suspected occlusion) at the end of Day 6. |
| Novolog Subjects - Rate of Infusion Set Failure at the End of Day 6 | 144 hours | Independently evaluate rate of infusion set failure due to unexplained hyperglycemia (i.e. suspected occlusion) at the end of Day 6. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Humalog Subject - Rate of Infusion Set Failure at the End of Day 7. | 168 hours | Evaluate rate of infusion set failure due to unexplained hyperglycemia (i.e. suspected occlusion) at the end of Day 7. |
| Novolog Subjects - Rate of Infusion Set Failure at the End of Day 7. | 168 hours | Independently evaluated rate of infusion set failure due to unexplained hyperglycemia (i.e. suspected occlusion) at the end of Day 7. |
Countries
United States
Participant flow
Pre-assignment details
291 subjects consented and enrolled in the overall study. Of the 291, 28 subjects failed screening, 4 subjects passed screening but did not attempt any EWIS, 259 subjects wore at least one EWIS, 11 subjects early withdraw, 248 subjects completed the study.
Participants by arm
| Arm | Count |
|---|---|
| Humalog Subjects Extended Wear Infusion Set Each Humalog subject was given 12 Extended Wear Infusion Sets to wear.
Extended Infusion Set: Humalog subjects were asked to wear each Extended Wear Infusion Set for at least 174 hours. | 132 |
| Novolog Subjects Extended Wear Infusion Set Each Novolog subject was given 12 Extended Wear Infusion Sets to wear.
Extended Infusion Set: Novolog subjects were asked to wear each Extended Wear Infusion Set for at least 174 hours. | 127 |
| Total | 259 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Withdrawal by Subject | 6 |
| Overall Study | Withdrawal due to not meeting inclusion and exclusion criteria | 1 |
Baseline characteristics
| Characteristic | Humalog Subjects Extended Wear Infusion Set | Novolog Subjects Extended Wear Infusion Set | Total |
|---|---|---|---|
| Age, Continuous | 43.4 years STANDARD_DEVIATION 14.3 | 46.7 years STANDARD_DEVIATION 13.7 | 45.0 years STANDARD_DEVIATION 14.1 |
| BMI (kg/m2) | 29.0 kg/m^2 STANDARD_DEVIATION 5.6 | 29.0 kg/m^2 STANDARD_DEVIATION 5.9 | 29.0 kg/m^2 STANDARD_DEVIATION 5.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 4 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 126 Participants | 123 Participants | 249 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Female | 68 Participants | 66 Participants | 134 Participants |
| Sex: Female, Male Male | 64 Participants | 61 Participants | 125 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 132 | 0 / 127 |
| other Total, other adverse events | 59 / 132 | 60 / 127 |
| serious Total, serious adverse events | 2 / 132 | 1 / 127 |
Outcome results
Primary
Humalog Subjects - Rate of Infusion Set Failure at the End of Day 6
Evaluate rate of infusion set failure due to unexplained hyperglycemia (i.e. suspected occlusion) at the end of Day 6.
Time frame: 144 hours
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Extended Wear Infusion Set | Humalog Subjects - Rate of Infusion Set Failure at the End of Day 6 | 0.06 Percentage of Extended Wear Infusion Set |
Primary
Novolog Subjects - Rate of Infusion Set Failure at the End of Day 6
Independently evaluate rate of infusion set failure due to unexplained hyperglycemia (i.e. suspected occlusion) at the end of Day 6.
Time frame: 144 hours
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Extended Wear Infusion Set | Novolog Subjects - Rate of Infusion Set Failure at the End of Day 6 | 0.27 Percentage of Extended Wear Infusion Set |
Secondary
Humalog Subject - Rate of Infusion Set Failure at the End of Day 7.
Evaluate rate of infusion set failure due to unexplained hyperglycemia (i.e. suspected occlusion) at the end of Day 7.
Time frame: 168 hours
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Extended Wear Infusion Set | Humalog Subject - Rate of Infusion Set Failure at the End of Day 7. | 0.13 Percentage of Extended Wear Infusion Set |
Secondary
Novolog Subjects - Rate of Infusion Set Failure at the End of Day 7.
Independently evaluated rate of infusion set failure due to unexplained hyperglycemia (i.e. suspected occlusion) at the end of Day 7.
Time frame: 168 hours
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Extended Wear Infusion Set | Novolog Subjects - Rate of Infusion Set Failure at the End of Day 7. | 0.41 Percentage of Extended Wear Infusion Set |