Insulin Dependent Diabetes Mellitus 1
Conditions
Brief summary
To determine time to set failure when the Convatec Inset II with Lantern technology (Convatec Lantern) infusion set with multi-slitted catheter is worn for up to 10 days
Detailed description
This is a pilot study to obtain preliminary data to determine the time to set failure when the Lantern infusion set is worn for up to 10 days. The study is not intended for registration purposes or to support a 510(k) submission. The study will be conducted at one site: Stanford University. This study will enroll 24 subjects (as per FDA approval) to establish the maximum length of Lantern infusion set wear when 80% of sets are still functional (excluding accidental pull-outs). Each participant will place the set and wear it for 10 days or until set failure and data will be collected on the cause of set failure. If a set is accidentally pulled out, it can be replaced by the subject. Failures are based on: 1. Presence of serum ketones with hyperglycemia 2. Unexplained hyperglycemia 3. Signs of infection at the infusion site 4. Pump occlusion alarm 5. Adhesive failure Since infusion set failures will occur after variable lengths of wear, regularly scheduled visits are unlikely to capture the day of an infusion set failure. Instead the subject will be taught how to insert the set, measure erythema and induration with a ruler marked in millimeters and to take a picture of the infusion site. Subjects will be instructed to text the study team when they remove their infusion set and to send a picture of the infusion site and measurements. If there is any evidence of an infection (≥10 mm of erythema or induration), they will be asked to come in that day for an unscheduled visit.
Interventions
DEVICEInset II with Lantern Technology
Each participant will insert the Inset II with Lantern technology and wear it for 10 days or until set failure and data will be collected on the cause of set failure. The infusion set will be used with their usual insulin pump.
Sponsors
ConvaTec Inc.
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
To determine length of infusion set wear for up to a maximum of 10 days
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Type 1 Diabetes by clinical definition 1. Age 22 and over 2. On tethered insulin pump therapy for at least 3 months using Lispro or Aspart insulin. 3. Hemoglobin A1c level less than or equal to 9% 4. Eating more than 60 grams of carbohydrate each day 5. For females, not currently known to be pregnant 6. Understanding and willingness to follow the protocol and sign informed consent 7. Willingness to wear the experimental infusion sets 8. Willingness to have photographs taken of their infusion sites 9. Ability to speak, read and write in the language of the investigators
Exclusion criteria
The presence of any of the following is an exclusion for the study: 1. Diabetic ketoacidosis in the past 3 months 2. Severe hypoglycemia resulting in seizure or loss of consciousness within 3 months prior to enrollment 3. Pregnant or lactating 4. Known tape allergies 5. Active infection 6. A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol 7. Known cardiovascular events in the last 6 months 8. Known acute proliferative diabetic retinopathy 9. Known adrenal disorder 10. Current treatment for a seizure disorder 11. Inpatient psychiatric treatment in the past 6 months 12. Lack of stability on medication 1 month prior to enrollment including antihypertensive, thyroid, anti-depressant or lipid lowering medication. 13. Use of SGLT inhibitor 14. Suspected drug or alcohol abuse 15. Dialysis or end stage kidney disease Note: Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Infusion Set Failure | 10 days of infusion set wear | Time to when the infusion set fails and needs to be replaced. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lantern Infusion Set Multi-slitted lantern infusion set
Inset II with Lantern Technology: Each participant will insert the Inset II with Lantern technology and wear it for 10 days or until set failure and data will be collected on the cause of set failure. The infusion set will be used with their usual insulin pump. | 22 |
| Total | 22 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 2 |
Baseline characteristics
| Characteristic | Lantern Infusion Set |
|---|---|
| Age, Continuous | 40.1 years STANDARD_DEVIATION 14.3 |
| Body Mass Index | 28.0 kg/m^2 STANDARD_DEVIATION 4.4 |
| Diabetes Duration | 26.4 years STANDARD_DEVIATION 12.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| HbA1c | 7.1 % glcosylated HBG:total HBG STANDARD_DEVIATION 0.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 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 | 19 Participants |
| Region of Enrollment United States | 22 Participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 12 Participants |
| Total Daily Insulin Dose (Units) | 48.0 units STANDARD_DEVIATION 16.7 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 24 |
| other Total, other adverse events | 12 / 24 |
| serious Total, serious adverse events | 0 / 24 |
Outcome results
Primary
Time to Infusion Set Failure
Time to when the infusion set fails and needs to be replaced.
Time frame: 10 days of infusion set wear
Population: Participants who completed the protocol are included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lantern Infusion Set | Time to Infusion Set Failure | 8.0 days | Standard Deviation 2.4 |