A study to compare the compatibility and safety of LY900014 with insulin lispro given by insulin pump in patients with type 1 diabetes

Phase 1

• Conditions: Diabetes Mellitus, Type 1; MedDRA version: 20.0Level: PTClassification code 10012601Term: Diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2017-002374-39-ES
• Lead Sponsor: illy S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-15
• Last Update Posted: 17 September 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

-You are diagnosed with type 1 diabetes and have been using insulin continuously for at least 12 months
-You are 18 years of age or older
-You have been using an insulin pump with ‘rapid-acting insulin’ for at least 6 months and using the same rapid-acting insulin for at least the past 30 days
-You have experience using Continuous Glucose Monitoring (CGM) or Flash Glucose Monitoring (FGM) for at least 60 days during the past 12 months
-You have been using the MiniMed 530G or 630G (US) or the MiniMed 640G (EU) insulin pump for at least the past 30 days
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 34
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 14

Exclusion Criteria

You have had more than 1 emergency treatment for very low blood glucose in the last 6 months.
You have had more than 1 emergency treatment for poor glucose control in the last 6 months.
You are taking certain diabetes medications that are not allowed for study participation.
You have major problems with your heart, kidneys, liver, or you have a blood disorder.
You have had or are now being treated for certain types of cancer that prevents you from study participation.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified