NCT02687256

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 22, 2016

Completed
8 days until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

June 6, 2018

Status Verified

June 1, 2018

Enrollment Period

1.7 years

First QC Date

February 9, 2016

Last Update Submit

June 1, 2018

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Time to an infusion set failure due to an occlusion

    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

    within 1 week

Secondary Outcomes (1)

  • signs of infection at insulin infusion site

    1 week

Study Arms (9)

Protocol 1: Standard then Extended Set

EXPERIMENTAL

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 setDevice: Standard Infusion setDrug: Heparin

Protocol 1: Extended then Standard Set

EXPERIMENTAL

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 setDevice: Standard Infusion setDrug: Heparin

Protocol 2 (Part 1): Sequence 1

EXPERIMENTAL

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 setDevice: Standard Infusion setDrug: Heparin

Protocol 2 (Part 1): Sequence 2

EXPERIMENTAL

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 setDevice: Standard Infusion setDrug: Heparin

Protocol 2 (Part 1): Sequence 3

EXPERIMENTAL

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 setDevice: Standard Infusion setDrug: Heparin

Protocol 2 (Part 1): Sequence 4

EXPERIMENTAL

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 setDevice: Standard Infusion setDrug: Heparin

Protocol 2 (Part 1): Sequence 5

EXPERIMENTAL

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 setDevice: Standard Infusion setDrug: Heparin

Protocol 2 (Part 2): Standard then Extended Set

EXPERIMENTAL

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 setDevice: Standard Infusion setDrug: Heparin

Protocol 2 (Part 1): Extended then Standard Set

EXPERIMENTAL

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 setDevice: Standard Infusion setDrug: Heparin

Interventions

Extended Wear infusion setDEVICE

For two of the 4 weeks the Extended Wear insulin infusion set will be used.

Protocol 1: Extended then Standard SetProtocol 1: Standard then Extended SetProtocol 2 (Part 1): Extended then Standard SetProtocol 2 (Part 1): Sequence 1Protocol 2 (Part 1): Sequence 2Protocol 2 (Part 1): Sequence 3Protocol 2 (Part 1): Sequence 4Protocol 2 (Part 1): Sequence 5Protocol 2 (Part 2): Standard then Extended Set
Standard Infusion setDEVICE

For two of the 4 weeks the Standard infusion set will be used

Also known as: Minimed
Protocol 1: Extended then Standard SetProtocol 1: Standard then Extended SetProtocol 2 (Part 1): Extended then Standard SetProtocol 2 (Part 1): Sequence 1Protocol 2 (Part 1): Sequence 2Protocol 2 (Part 1): Sequence 3Protocol 2 (Part 1): Sequence 4Protocol 2 (Part 1): Sequence 5Protocol 2 (Part 2): Standard then Extended Set
HeparinDRUG
Protocol 1: Extended then Standard SetProtocol 1: Standard then Extended SetProtocol 2 (Part 1): Extended then Standard SetProtocol 2 (Part 1): Sequence 1Protocol 2 (Part 1): Sequence 2Protocol 2 (Part 1): Sequence 3Protocol 2 (Part 1): Sequence 4Protocol 2 (Part 1): Sequence 5Protocol 2 (Part 2): Standard then Extended Set

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Clinical diagnosis of type 1 diabetes for at least one year and using an insulin pump for at least 12 months
  • The diagnosis of type 1 diabetes is based on the investigator's judgment; C-peptide level and antibody determinations are not needed.
  • Age 18 to 55 years
  • Hemoglobin A1c level less than or equal to 8.5%
  • Willing to use Novolog insulin while they are participating in the study
  • Total daily insulin dose is at least 0.3 units/kg/day
  • For females, not currently known to be pregnant
  • An understanding of and willingness to follow the protocol and sign the informed consent
  • Willingness to wear the experimental insulin infusion sets throughout the study
  • Must be able to understand spoken and written English

You may not qualify if:

  • Diabetic ketoacidosis in the past 3 months
  • blood urea nitrogen (BUN), Creatinine, or liver function test (ALT or AST) more than three times the upper limit of normal, or thrombocytopenia
  • Severe hypoglycemia resulting in seizure or loss of consciousness in the 3 months prior to enrollment
  • Pregnant or lactating females
  • Known tape allergies
  • 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 such as the following examples:
  • Inpatient psychiatric treatment in the past 6 months for either the subject or the subject's primary care giver (i.e., parent or guardian)
  • Presence of a known adrenal disorder
  • 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
  • Abuse of alcohol
  • Dialysis for renal failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Heparin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Bruce Buckingham, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

February 9, 2016

First Posted

February 22, 2016

Study Start

March 1, 2016

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

June 6, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

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.

Locations

US(1)