Evaluation of Extended Wear Infusion Set With 670G Hybrid Closed-Loop Therapy

Type 1 Diabetes Clinical Trial

Official title:

Evaluation of Extended Wear Infusion Set With 670G Hybrid Closed-Loop Therapy

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04284033
• Other study ID #: 52526
• Status: Withdrawn
• Phase: N/A
• Start date: February 14, 2017
• Est. completion date: April 20, 2018

Study information

• Verified date: August 2021
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 20, 2018
• Est. primary completion date: November 10, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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 insulin infusion set will be used

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	Number of infusion set failures due to "unexplained hyperglycemia"	Defined as: Glucose >250 mg/dL with failure of a correction dose to lower the glucose by 50 mg/dL; Ketones =0.6 mg/dL with a glucose reading of >250 mg/dL (in the absence of illness); Evidence of infection at the infusion site (erythema or induration >1cm in diameter); Pump occlusion alarm	14 days for each type of infusion set, with each type of infusion set worn twice
Secondary	Duration of infusion set wear	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.	14 days for each type of infusion set, with each type of infusion set worn twice