Evaluation of Extended Infusion Set Wear Using Medtronic Extended Wear Sof-set Infusion Set

Type 1 Diabetes Clinical Trial

Official title:

Evaluation of Extended Infusion Set Wear Using the Medtronic Extended Wear Sof-set Infusion Set

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02687256
• Other study ID #: IRB 36142
• Status: Completed
• Phase: Phase 1
• Start date: March 2016
• Est. completion date: November 2017

Study information

• Verified date: June 2018
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a blinded cross-over study to see if extended wear insulin infusion sets can prolong insulin infusion set wear up to 7 days in adults with Type 1 Diabetes.

Description:

This is a double blinded cross-over study. Subjects will be asked to wear infusion set either a standard infusion set or an extended wear infusion set. They will wear each infusion set twice, and the order of infusion set wear will be randomized with the first infusion set wear and then alternated over 4 weeks. By performing a cross over study using both experimental infusion sets and standard infusion sets, the investigators hope to see whether there is a benefit to using an extended wear infusion set.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

1. Clinical diagnosis of type 1 diabetes for at least one year and using an insulin pump for at least 12 months

2. The diagnosis of type 1 diabetes is based on the investigator's judgment; C-peptide level and antibody determinations are not needed.

3. Age 18 to 55 years

4. Hemoglobin A1c level less than or equal to 8.5%

5. Willing to use Novolog insulin while they are participating in the study

6. Total daily insulin dose is at least 0.3 units/kg/day

7. For females, not currently known to be pregnant

8. An understanding of and willingness to follow the protocol and sign the informed consent

9. Willingness to wear the experimental insulin infusion sets throughout the study

10. Must be able to understand spoken and written English

Exclusion Criteria:

1. Diabetic ketoacidosis in the past 3 months

2. blood urea nitrogen (BUN), Creatinine, or liver function test (ALT or AST) more than three times the upper limit of normal, or thrombocytopenia

3. Severe hypoglycemia resulting in seizure or loss of consciousness in the 3 months prior to enrollment

4. Pregnant or lactating females

5. Known tape allergies

6. Current treatment for a seizure disorder

7. Cystic fibrosis

8. Active infection

9. A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol such as the following examples:

10. Inpatient psychiatric treatment in the past 6 months for either the subject or the subject's primary care giver (i.e., parent or guardian)

11. Presence of a known adrenal disorder

12. 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

13. Abuse of alcohol

14. Dialysis for renal failure

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Device:
• Extended Wear infusion set
For two of the 4 weeks the Extended Wear insulin infusion set will be used.
• Standard Infusion set
For two of the 4 weeks the Standard infusion set will be used

Drug:
• Heparin

Locations

Country	Name	City	State
United States	Stanford University	Palo Alto	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	Medtronic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to an infusion set failure due to an occlusion	Glucose >250 mg/dL with failure of a correction dose to lower the glucose by 50 mg/dL, or ketones > or = 0.6 mg/dL with a glucose reading of >250 mg/dL (in the absence of illness), or a pump occlusion alarm	within 1 week
Secondary	signs of infection at insulin infusion site	erythema or induration of > 1cm in diameter at injection site	1 week