Back to resultsEvaluation of Extended Wear Infusion Set With 670G Hybrid Closed-Loop Therapy
Primary Purpose
Type 1 Diabetes
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Extended Wear Infusion Set
Standard Infusion Set
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes
Eligibility Criteria
Inclusion Criteria:
- 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
- Age ≥18 years
- Using Novolog or Humalog insulin at time of enrollment
- For females, not currently known to be pregnant
- An understanding of and willingness to follow the protocol and sign the informed consent
- Willing to have photographs taken of their infusion sites
- Willing to download their 670G pump every week to a research Carelink account
- Willing to submit a brief online questionnaire at the time of any infusion set failure
- Able to understand spoken or written English
- Hemoglobin A1c <8.5% at the time of enrollment
- Willing to perform three or more fingerstick glucose measurements each day
- Willing to sign a consent for release of medical information at the time of enrollment
- Willing to change their infusion pump insulin reservoirs at least every 6 days
Exclusion Criteria:
- Hypoglycemic seizure or loss of consciousness in the past 6 months
- Severe episode of DKA in the 6 months prior to study enrollment that was unrelated to an infusion set failure
- A known cardiovascular disease
- Active proliferative diabetic retinopathy
- Known tape allergy
- 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
- Inpatient psychiatric treatment in the past 6 months
- Presence of a known adrenal disorder
- 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
- Abuse of alcohol
- History of dialysis, renal failure or known eGFR <60 ml/min/1.73m2
- Has received a blood transfusion or required treatment for anemia in the three months prior to enrollment
Sites / Locations
- Stanford University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Standard then Extended Infusion Set
Extended then Standard Infusion Set
Arm Description
Participants will start with wearing the standard infusion set for up to 7 days, then switch to the Extended Wear infusion set for up to 7 days, then repeat the cycle for a total of 4 weeks
Participants will start with wearing the Extended Wear infusion set for up to 7 days, then switch to the standard infusion set for up to 7 days, then repeat the cycle for a total of 4 weeks
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT04284033
First Posted
February 22, 2020
Last Updated
August 29, 2021
Sponsor
Stanford University
Collaborators
Medtronic
1. Study Identification
Unique Protocol Identification Number
NCT04284033
Brief Title
Evaluation of Extended Wear Infusion Set With 670G Hybrid Closed-Loop Therapy
Official Title
Evaluation of Extended Wear Infusion Set With 670G Hybrid Closed-Loop Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Change of sponsor and trial design
Study Start Date
February 14, 2017 (Actual)
Primary Completion Date
November 10, 2017 (Actual)
Study Completion Date
April 20, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
Medtronic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard then Extended Infusion Set
Arm Type
Experimental
Arm Description
Participants will start with wearing the standard infusion set for up to 7 days, then switch to the Extended Wear infusion set for up to 7 days, then repeat the cycle for a total of 4 weeks
Arm Title
Extended then Standard Infusion Set
Arm Type
Experimental
Arm Description
Participants will start with wearing the Extended Wear infusion set for up to 7 days, then switch to the standard infusion set for up to 7 days, then repeat the cycle for a total of 4 weeks
Intervention Type
Device
Intervention Name(s)
Extended Wear Infusion Set
Intervention Description
For two of the 4 weeks, the Extended Wear insulin infusion set will be used
Intervention Type
Device
Intervention Name(s)
Standard Infusion Set
Intervention Description
For two of the 4 weeks, the standard insulin infusion set will be used
Primary Outcome Measure Information:
Title
Number of infusion set failures due to "unexplained hyperglycemia"
Description
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
Time Frame
14 days for each type of infusion set, with each type of infusion set worn twice
Secondary Outcome Measure Information:
Title
Duration of infusion set wear
Description
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.
Time Frame
14 days for each type of infusion set, with each type of infusion set worn twice
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Age ≥18 years
Using Novolog or Humalog insulin at time of enrollment
For females, not currently known to be pregnant
An understanding of and willingness to follow the protocol and sign the informed consent
Willing to have photographs taken of their infusion sites
Willing to download their 670G pump every week to a research Carelink account
Willing to submit a brief online questionnaire at the time of any infusion set failure
Able to understand spoken or written English
Hemoglobin A1c <8.5% at the time of enrollment
Willing to perform three or more fingerstick glucose measurements each day
Willing to sign a consent for release of medical information at the time of enrollment
Willing to change their infusion pump insulin reservoirs at least every 6 days
Exclusion Criteria:
Hypoglycemic seizure or loss of consciousness in the past 6 months
Severe episode of DKA in the 6 months prior to study enrollment that was unrelated to an infusion set failure
A known cardiovascular disease
Active proliferative diabetic retinopathy
Known tape allergy
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
Inpatient psychiatric treatment in the past 6 months
Presence of a known adrenal disorder
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
Abuse of alcohol
History of dialysis, renal failure or known eGFR <60 ml/min/1.73m2
Has received a blood transfusion or required treatment for anemia in the three months prior to enrollment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce Buckingham, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of Extended Wear Infusion Set With 670G Hybrid Closed-Loop Therapy
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