Type 1 Diabetes
Conditions
Brief summary
This is a randomized trial to determine if an extended wear infusion set can be worn for up to 7 days with a hybrid closed-loop system in adult with Type 1 Diabetes
Detailed description
This study will compare use of a standard infusion set with an extended wear infusion set. Subjects will be asked to wear both types of sets twice for up to 7 days, alternating wear of set type over 4 weeks. The order of infusion set wear will be randomized with the first set wear. The investigators aim 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 insulin infusion set will be used
Sponsors
Medtronic
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Clinical diagnosis of type 1 diabetes for more than one year, using an insulin infusion pump for at least 6 months, and using the 670G pump for at least 3 months 2. Age ≥18 years 3. Using Novolog or Humalog insulin at time of enrollment 4. For females, not currently known to be pregnant 5. An understanding of and willingness to follow the protocol and sign the informed consent 6. Willing to have photographs taken of their infusion sites 7. Willing to download their 670G pump every week to a research Carelink account 8. Willing to submit a brief online questionnaire at the time of any infusion set failure 9. Able to understand spoken or written English 10. Hemoglobin A1c \<8.5% at the time of enrollment 11. Willing to perform three or more fingerstick glucose measurements each day 12. Willing to sign a consent for release of medical information at the time of enrollment 13. Willing to change their infusion pump insulin reservoirs at least every 6 days
Exclusion criteria
1. Hypoglycemic seizure or loss of consciousness in the past 6 months 2. Severe episode of DKA in the 6 months prior to study enrollment that was unrelated to an infusion set failure 3. A known cardiovascular disease 4. Active proliferative diabetic retinopathy 5. Known tape allergy 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 10. Inpatient psychiatric treatment in the past 6 months 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 last 2 months prior to enrollment in the study 13. Abuse of alcohol 14. History of dialysis, renal failure or known eGFR \<60 ml/min/1.73m2 15. Has received a blood transfusion or required treatment for anemia in the three months prior to enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of infusion set failures due to unexplained hyperglycemia | 14 days for each type of infusion set, with each type of infusion set worn twice | Defined as: 1. Glucose \>250 mg/dL with failure of a correction dose to lower the glucose by 50 mg/dL 2. Ketones ≥0.6 mg/dL with a glucose reading of \>250 mg/dL (in the absence of illness) 3. Evidence of infection at the infusion site (erythema or induration \>1cm in diameter) 4. Pump occlusion alarm |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of infusion set wear | 14 days for each type of infusion set, with each type of infusion set worn twice | The maximum number of days that 75% of the infusion sets are still working, excluding those that kinked on insertion or were accidentally pulled out. |
Countries
United States
Outcome results
None listed