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Safety and Efficacy of BC LisPram

NCT04972175 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2022-02-16

No results posted yet for this study

Summary

This pilot study is a 50-hour randomized, open-label, crossover study in an inpatient setting assessing the safety, pharmacodynamics, pharmacokinetics, and closed-loop efficacy of i) BC LisPram delivery and ii) rapid insulin delivery.

Conditions

  • Type1 Diabetes Mellitus

Interventions

DRUG

50-Hour Intervention - Rapid Insulin lispro

Subcutaneous-delivery of insulin lispro using pump therapy.

DRUG

50-Hour Intervention - BC LisPram

Subcutaneous-delivery of BC LisPram using pump therapy.

Sponsors & Collaborators

  • Adocia

    collaborator INDUSTRY

  • Michael Tsoukas

    lead NETWORK

Principal Investigators

  • Michael Tsoukas, MD · Applied Medical Informatics Research Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-28
Primary Completion
2022-06-30
Completion
2022-06-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04972175 on ClinicalTrials.gov