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

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ClinicalTrials.gov Identifier: NCT02687256
Recruitment Status : Completed
First Posted : February 22, 2016
Last Update Posted : June 5, 2018
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Bruce A. Buckingham, Stanford University

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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Device: Extended Wear infusion set Device: Standard Infusion set Drug: Heparin Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of Extended Infusion Set Wear Using the Medtronic Extended Wear Sof-set Infusion Set
Actual Study Start Date : March 2016
Actual Primary Completion Date : November 2017
Actual Study Completion Date : November 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Protocol 1: Standard then Extended Set
Participants will wear the control (standard) infusion set for 1 week, then switch to the experimental Extended Wear infusion set in combination with Heparin 400 IU for 1 week, then will repeat the cycle for a total of 4 weeks.
Device: Extended Wear infusion set
For two of the 4 weeks the Extended Wear insulin infusion set will be used.

Device: Standard Infusion set
For two of the 4 weeks the Standard infusion set will be used
Other Name: Minimed

Drug: Heparin
Experimental: Protocol 1: Extended then Standard Set
Participants will wear the experimental Extended Wear infusion set in combination with Heparin 400 IU for 1 week, then switch to the control (standard) infusion set for 1 week, then will repeat the cycle for a total of 4 weeks.
Device: Extended Wear infusion set
For two of the 4 weeks the Extended Wear insulin infusion set will be used.

Device: Standard Infusion set
For two of the 4 weeks the Standard infusion set will be used
Other Name: Minimed

Drug: Heparin
Experimental: Protocol 2 (Part 1): Sequence 1
Participants will wear the control (standard) infusion set for 1 week, then the Extended Wear infusion set with heparin at 40 IU (week 1), 80 IU (week 2), 120 IU (week 3), and 200 IU (week 4).
Device: Extended Wear infusion set
For two of the 4 weeks the Extended Wear insulin infusion set will be used.

Device: Standard Infusion set
For two of the 4 weeks the Standard infusion set will be used
Other Name: Minimed

Drug: Heparin
Experimental: Protocol 2 (Part 1): Sequence 2
Participants will wear the Extended Wear infusion set with heparin at 40 IU (week 1), 80 IU (week 2), 120 IU (week 3), and 200 IU (week 4), then the control (standard) infusion set (week 5).
Device: Extended Wear infusion set
For two of the 4 weeks the Extended Wear insulin infusion set will be used.

Device: Standard Infusion set
For two of the 4 weeks the Standard infusion set will be used
Other Name: Minimed

Drug: Heparin
Experimental: Protocol 2 (Part 1): Sequence 3
Participants will wear the Extended Wear infusion set with heparin at 80 IU (week 1), 120 IU (week 2), and 200 IU (week 3), then the control (standard) infusion set (week 4), then the Extended Wear infusion set with heparin at 40 IU (week 5).
Device: Extended Wear infusion set
For two of the 4 weeks the Extended Wear insulin infusion set will be used.

Device: Standard Infusion set
For two of the 4 weeks the Standard infusion set will be used
Other Name: Minimed

Drug: Heparin
Experimental: Protocol 2 (Part 1): Sequence 4
Participants will wear the Extended Wear infusion set with heparin at 120 IU (week 1), and 200 IU (week 2), then the control (standard) infusion set (week 3), then the Extended Wear infusion set with heparin at 40 IU (week 4), and 80 IU (week 5).
Device: Extended Wear infusion set
For two of the 4 weeks the Extended Wear insulin infusion set will be used.

Device: Standard Infusion set
For two of the 4 weeks the Standard infusion set will be used
Other Name: Minimed

Drug: Heparin
Experimental: Protocol 2 (Part 1): Sequence 5
Participants will wear the Extended Wear infusion set with heparin at 200 IU (week 1), then the control (standard) infusion set (week 2), then the Extended Wear infusion set with heparin at 40 IU (week 3), 80 IU (week 4), and 80 IU (week 5).
Device: Extended Wear infusion set
For two of the 4 weeks the Extended Wear insulin infusion set will be used.

Device: Standard Infusion set
For two of the 4 weeks the Standard infusion set will be used
Other Name: Minimed

Drug: Heparin
Experimental: Protocol 2 (Part 2): Standard then Extended Set
Participants will wear the control (standard) infusion set for 1 week, then switch to the experimental Extended Wear infusion set in combination with Heparin 80 IU for 1 week, then will repeat the cycle for a total of 4 weeks.
Device: Extended Wear infusion set
For two of the 4 weeks the Extended Wear insulin infusion set will be used.

Device: Standard Infusion set
For two of the 4 weeks the Standard infusion set will be used
Other Name: Minimed

Drug: Heparin
Experimental: Protocol 2 (Part 1): Extended then Standard Set
Participants will wear the experimental Extended Wear infusion set in combination with Heparin 80 IU for 1 week, then switch to the control (standard) infusion set for 1 week, then will repeat the cycle for a total of 4 weeks.
Device: Extended Wear infusion set
For two of the 4 weeks the Extended Wear insulin infusion set will be used.

Device: Standard Infusion set
For two of the 4 weeks the Standard infusion set will be used
Other Name: Minimed

Drug: Heparin



Primary Outcome Measures :
  1. Time to an infusion set failure due to an occlusion [ Time Frame: 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 Outcome Measures :
  1. signs of infection at insulin infusion site [ Time Frame: 1 week ]
    erythema or induration of > 1cm in diameter at injection site



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02687256


Locations
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United States, California
Stanford University
Palo Alto, California, United States, 94304
Sponsors and Collaborators
Stanford University
Medtronic
Investigators
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Principal Investigator: Bruce Buckingham, MD Stanford University

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Responsible Party: Bruce A. Buckingham, M.D., Stanford University
ClinicalTrials.gov Identifier: NCT02687256     History of Changes
Other Study ID Numbers: IRB 36142
First Posted: February 22, 2016    Key Record Dates
Last Update Posted: June 5, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: To maintain the integrity of this research study, the subject is told they may not have access to any health information developed as part of this study until it is completed.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No

Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Heparin
Calcium heparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action