Transdermally Delivered Human Insulin Product
A Comparison of Injected Insulin Replacement Therapy With A Novel Transdermally Delivered Human Insulin Product
1 other identifier
observational
1
1 country
1
Brief Summary
An Early Feasibility Study of a device formulation to deliver human insulin across intact skin
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Sep 2017
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 9, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 4, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 4, 2018
CompletedFirst Submitted
Initial submission to the registry
May 22, 2018
CompletedFirst Posted
Study publicly available on registry
June 4, 2018
CompletedJune 6, 2018
May 1, 2018
5 months
May 22, 2018
June 2, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Insulin response
Measurement of down modulation of serum glucose as measured by a standard blood glucose meter not otherwise attributable to injected insulin
8-24 hours
Study Arms (1)
TD Insulin Pilot
Test of novel transdermal insulin (TD Insulin) formulations
Interventions
Human Insulin USP formulated in a solution capable of transdermal delivery.
Eligibility Criteria
Single patient, brittle T1D patient
You may qualify if:
- Brittle T1D patient with poor insulin sensitivity requiring more than 3,000 IUs on insulin a day
You may not qualify if:
- High insulin sensitivity
- well managed serum glucose
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Langford Research Institute
Palm Beach Gardens, Florida, 33410, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
William D Kirsh, D.O.
Sentry Data Systems
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 22, 2018
First Posted
June 4, 2018
Study Start
September 9, 2017
Primary Completion
February 4, 2018
Study Completion
February 4, 2018
Last Updated
June 6, 2018
Record last verified: 2018-05