Study Condition(s): Type 1 Diabetes

A Study of LY900014 and Insulin Lispro With an External Continuous Subcutaneous Insulin Infusion System in Adult Participants With Type 1 Diabetes (PRONTO-Pump)

Study Alias: ITSI

Study Identifier(s): Tool Tip Icon {{ defaultRegistry.registryAnchorText }} NCT03433677 {{ currentLocaleObject.registryAnchorText }}

Completed Completed

Study Purpose

The purpose of this study is to evaluate the compatibility and safety of LY900014 and insulin lispro with an insulin pump in adults with type 1 diabetes.

Completed Study

The results of this study are not yet available.

Who Participated? Tool Tip Icon

Here you can find out a bit more about the requirements for volunteers who took part in this study

Gender

Male Female

Age

18+ years

Time Commitment

Your participation could last about 19 weeks and include up to 10 visits to the study center.

-Participants must have been diagnosed with type 1 diabetes and have been using insulin continuously for at least 12 months

-Participants must be using an insulin pump with “rapid-acting insulin” for at least 6 months and the same “rapid acting insulin” for at least the past 30 days

-Participants must have experience using Continuous Glucose Monitoring (CGM) or Flash Glucose Monitoring (FGM) for at least 60 days during the past 12 months

-Participants must have hemoglobin A1c (HbA1c) values ≤8.5%

-Participants must have been using the MiniMed 530G or 630G (US) or the MiniMed 640G (EU) insulin pump for at least the past 30 days

-Participants must not have had more than 1 emergency treatment for very low blood glucose or poor glucose control (very high blood sugar or diabetic ketoacidosis) in the last 6 months

-Participants must not have significant abnormal accumulation of fat, loss of fat tissue, or scars just under the skin in areas of infusion or have a history of an infection at an infusion site within 90 days prior to screening

-Participants must not be taking medication for diabetes by mouth or injection, other than rapid-acting insulin via pump in the 90 days prior to screening. Occasional insulin injections by pen or syringe are allowed, for example, due to pump malfunction or unexplained high blood sugar that did not respond to insulin by pump

-Participants must not have major problems with their heart, kidneys, liver, or have a blood disorder

-Participants must not have a history of certain types of cancer nor may they be in treatment for these cancers

Where This Study Took Place Tool Tip Icon

5 locations participated
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