Duration of Infusion Set Function: Quick-Set Teflon Catheter Versus Sure-T Steel Infusion Set Catheter

Diabetes Mellitus Clinical Trial

Official title:

Duration of Infusion Set Function: A Study Comparing the Quick-Set Teflon Catheter vs Sure-T Steel Infusion Set Catheter

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01288729
• Other study ID #: SU-01272011-7439
• Status: Completed
• Phase: N/A
• First received: January 31, 2011
• Last updated: April 8, 2015
• Start date: January 2011
• Est. completion date: July 2011

Study information

• Verified date: April 2015
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This is an open label cross over study looking to compare the length of infusion set wear using a teflon catheter or a steel catheter.

Description:

If you choose to participate, you will be assigned to start with either a Quick-Set Teflon Catheter or a Sure-T Steel Catheter for your insulin pump infusion set. You will alternate catheter types weekly for four weeks; ie, at the end of the study, you will have used a Teflon catheter for two weeks, and a steel catheter for two weeks. We will ask you to wear each catheter once it is inserted for one week, or until the infusion set fails. Infusion set failure is 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) Your blood glucose 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.

You 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, you must obtain a fingerstick glucose to confirm the result. All insulin dose decisions must be made using your home glucose meter results, and should not be based on sensor results. You will be instructed on how to identify infusion set failure. You will follow-up weekly in one of our test centers for a total of five visits:

Visit 1: The protocol will be reviewed. A fingerstick Hemoglobin A1c value will be obtained. Detailed instruction on use of the Medtronic Real-Time Continuous Glucose Monitor (CGM) will take place. You will receive instruction on how to insert the insulin pump infusion set to which you have been initially assigned. You will fill a new reservoir with Novolog insulin, and insert the infusion set. You will be taught how to refill your pump reservoir, in case your insulin needs to be refilled before the insertion set needs to be changed. You will be instructed on how to recognize the signs of infusion set failure. You will also be instructed to monitor blood sugars at home with a glucose meter, and to check serum ketones if a blood sugar is >250 mg/dL. For this purpose, you will be provided with an Ultra glucose meter, and a Precision Xtra ketone meter, to be used during the study.

At home you 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.

Any blood sample collected will be destroyed once study is complete. We will not be storing samples.

Visit 2: Seven days after the first infusion set was inserted, the infusion and sensor insertion sites will be examined and photographed. The insulin pump, blood glucose meter, Precision Xtra ketone meter, and the CGM will have data downloaded for review. You will then have the other infusion set inserted; i.e. if you initially had a Sure-T Steel Catheter, you will now have a Quick-Set Teflon catheter placed (in a new location).

Visit 3: Follows the same protocol and uses the same type of insertion set as in visit 1.

Visit 4: Follows the same protocol and uses the same type of insertion set as in visit 2.

Visit 5: Seven days after the fourth infusion set was inserted, the infusion and sensor insertion sites will be examined and photographed. The insulin pump, blood glucose meter, Precision Xtra ketone meter, and the CGM will have data downloaded for review. This fifth visit will conclude your participation in the study. All study materials, including the Continuous Glucose Monitor (CGM), will be returned.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Device:
• Sure-T or Quick-Set
Participants will wear Quick-Set Teflon Catheter or Sure-T Steel Infusion Set Catheter for 2 weeks each during the active study time

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of wear of infusion site		5 weeks	Yes
Secondary	glucose values at time of site failure		5 weeks	No