Type 1 Diabetes
Conditions
Brief 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.
Detailed 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.
Interventions
For two of the 4 weeks the Extended Wear insulin infusion set will be used.
DEVICEStandard Infusion set
For two of the 4 weeks the Standard infusion set will be used
DRUGHeparin
Sponsors
Medtronic
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to an infusion set failure due to an occlusion | within 1 week | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| signs of infection at insulin infusion site | 1 week | erythema or induration of \> 1cm in diameter at injection site |
Countries
United States
Outcome results
None listed