Diabetes Mellitus
Conditions
Brief summary
This is an open-label cross over study looking to compare the length of infusion set wear between a teflon catheter (Quick-Set) or a steel (Sure-T) catheter.
Detailed description
Currently infusion sets are approved for 2-3 days of wear. In this study subjects will wear each infusion set for up to 7 days or until the infusion set fails. Subjects will alternate between wearing the Quick-Set Teflon catheter and the Sure-T steel catheter each week. They will wear each infusion set twice. For the study, subjects will be provided with an investigational Medtronic Real-Time Continuous Glucose Monitor (CGM) Enlite Sensor/Serter to help identify, serious hyperglycemia or hypoglycemia during the study. This sensor is not yet FDA approved, but is similar to commercially available sensors. If the sensor detects a high or low glucose, subject must obtain a fingerstick glucose to confirm the result. In the study, all insulin dose and other treatment decisions will be made using glucose meter results, and will not be based on sensor results. Subjects will be instructed on how to identify infusion set failures. Infusion set failure are defined as: 1) Blood ketones greater than 0.6 mmol/L, 2) Evidence of infection at the infusion site (such as redness of more than 4 mm), or 3) Blood glucose that does not decrease by at least 50 mg/dL within 1 hour of a correction bolus to treat a blood glucose greater than 300 mg/dL. Subjects will follow-up weekly in one of our test centers for a total of five visits. At home subjects will be asked to keep a log recording measurements of redness and induration at the infusion site when it is changed prior to the study visit.
Interventions
DEVICESure-T Steel Infusion Set Catheter
Participants will wear Quick-Set Teflon Catheter or Sure-T Steel Infusion Set Catheter for 2 weeks each during the active study time
DEVICEQuick-Set Teflon Catheter
Participants will wear Quick-Set Teflon Catheter or Sure-T Steel Infusion Set Catheter for 2 weeks each during the active study time
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of type 1 diabetes for at least one year and using an insulin pump for at least 3 months * The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed. * Age 12 to 45 years * For females, not currently known to be pregnant * An understanding of and willingness to follow the protocol and sign the informed consent * Hemoglobin A1c level less than or equal to 10% * Medtronic Continuous subcutaneous insulin infusion pump * Must be able to understand spoken or written English
Exclusion criteria
* Diabetic ketoacidosis in the past 6 months * Severe hypoglycemia resulting in seizure or loss of consciousness in the 6 months prior to enrollment * Current treatment for a seizure disorder * Cystic fibrosis * Active infection * A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol such as the following examples: * Inpatient psychiatric treatment in the past 6 months for either the subject or the subject's primary care giver (i.e., parent or guardian) * Presence of a known adrenal disorder * If on antihypertensive, thyroid, anti-depressant or lipid lowering medication, lack of stability on the medication for the past 2 months prior to enrollment in the study * Abuse of alcohol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Length of Wear of Infusion Site | 5 weeks | Comparison of the length of wear (hours) of Sure-T Steel Infusion Set Catheter versus Quick-Set Teflon Catheter. Infusion sets are currently approved for wear 2-3 days (24-72 hours). Participants wore each set for up to 7 days twice. Outcome measure is presented according to the intervention (Steel or Teflon catheter). |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1 - Steel Cathetar, Then Teflon Participants will alternate between wearing the Sure-T Steel Infusion Set Catheter for 7 days, then the Quick-Set Teflon for 7 days.They will wear each set twice starting with the Sure-T Steel Infusion Set. | 10 |
| Group 2 - Teflon Cathetar, the Steel Participants will alternate between wearing the Quick-Set Teflon catheter for 7 days, then the Quick-Set Teflon for 7 days. They will wear each set twice starting with the Quick-Set Teflon set. | 10 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Group 1 - Steel Cathetar, Then Teflon | Group 2 - Teflon Cathetar, the Steel | Total |
|---|---|---|---|
| Age, Continuous | 22.3 years STANDARD_DEVIATION 8.8 | 22.3 years STANDARD_DEVIATION 8.8 | 22.3 years STANDARD_DEVIATION 8.8 |
| Gender Female | 4 Participants | 4 Participants | 8 Participants |
| Gender Male | 6 Participants | 6 Participants | 12 Participants |
| Region of Enrollment United States | 10 participants | 10 participants | 20 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 7 / 20 | 7 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
Length of Wear of Infusion Site
Comparison of the length of wear (hours) of Sure-T Steel Infusion Set Catheter versus Quick-Set Teflon Catheter. Infusion sets are currently approved for wear 2-3 days (24-72 hours). Participants wore each set for up to 7 days twice. Outcome measure is presented according to the intervention (Steel or Teflon catheter).
Time frame: 5 weeks
Population: Participants with available data were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sure-T Steel Infusion Set Catheter | Length of Wear of Infusion Site | 137 hours |
| Quick-Set Teflon Catheter | Length of Wear of Infusion Site | 145 hours |