Loading clinical trials...

A Study of LY900014 and Insulin Lispro With an External Continuous Subcutaneous Insulin Infusion System in Adult Participants With Type 1 Diabetes | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

A Prospective, Randomized, Double-Blind, Crossover Comparison Evaluating Compatibility and Safety of LY900014 and Insulin Lispro With an External Continuous Subcutaneous Insulin Infusion System in Adult Patients With Type 1 Diabetes (PRONTO-Pump)

NCT03433677•Eli Lilly and Company

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the compatibility and safety of LY900014 and insulin lispro with an external continuous subcutaneous insulin infusion system in adult participants with type 1 diabetes.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Diagnosed with type 1 diabetes and have been using insulin continuously for at least 12 months.
•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.
•Have experience using Continuous Glucose Monitoring (CGM) or Flash Glucose Monitoring (FGM) for at least 60 days during the past 12 months.
•Have hemoglobin A1c values ≤8.5%, as determined by the central laboratory at screening.
•Have a body mass index (BMI) of ≤35 kilograms per meter squared at screening.
•Have been using the MiniMed 530G or 630G (US) or the MiniMed 640G (EU) insulin pump for at least the past 30 days.

Exclusion Criteria

•Have had more than 1 emergency treatment for very low blood glucose in the last 6 months.
•Have had more than 1 emergency treatment for poor glucose control (hyperglycemia or diabetic ketoacidosis) in the last 6 months.
•Have significant insulin resistance defined as having received a total daily dose of insulin \>1.2 units per kilogram (U/kg) at screening, as determined by the average total daily insulin dose over the 3 days prior to screening divided by weight in kilograms based on investigator review of the participant's pump history.
•Have significant lipohypertrophy, lipoatrophy, or scars within the subcutaneous tissue in areas of infusion or have a history of abscess at an infusion site within the last 90 days prior to screening.
•Are receiving any oral or injectable medication intended for the treatment of diabetes mellitus other than rapid-acting analog insulin via CSII in the 90 days prior to screening. Occasional pen or syringe injection of insulin is allowed, for example, due to pump malfunction or unexplained hyperglycemia not responsive to pump correction bolus.
•Taking certain diabetes medications that are not allowed for study participation.
•Have major problems with heart, kidneys, liver, or have a blood disorder.
•Have had or are now being treated for certain types of cancer that prevents study participation.

Locations (5)

Valley Research

Fresno, California, United States

Barbara Davis Center for Childhood Diabetes

Aurora, Colorado, United States

Atlanta Diabetes Associates

Atlanta, Georgia, United States

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Seville, Spain

For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.

Seville, Spain

Key Dates

Start Date

February 21, 2018

Primary Completion Date

September 4, 2018

Completion Date

September 4, 2018

Last Updated

October 8, 2019

Enrollment

ACTUAL participants

Conditions

Diabetes Type 1

Interventions

LY900014

DRUG

Insulin lispro

DRUG

Disentangling the Effect of Brain Insulin Resistance on Brain Health

NCT07374705

Diabetes Type 2Diabetes Type 1

View study

RECRUITINGPHASE3

A Clinical Trial to Evaluate The Effects of Semaglutide and Empagliflozin Combined to Automated Insulin Delivery on Diabetes Control in Adults Living With Type 1 Diabetes

NCT06894784

Diabetes Type 1

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 8, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Disentangling the Effect of Brain Insulin Resistance on Brain Health

A Clinical Trial to Evaluate The Effects of Semaglutide and Empagliflozin Combined to Automated Insulin Delivery on Diabetes Control in Adults Living With Type 1 Diabetes

Time in rANge vs. Time in nOrmal Glycemia for Better Glycemic Control

Inpatient Evaluation of the MD-Logic Artificial Pancreas System in Patients With Type 1 Diabetes

Treatment Satisfaction of Insulin Glargine Plus Insulin Apidra Compared With NPH Insulin Plus Insulin Apidra in Recently Diagnosed Type 1 Diabetes Children and Adolescents