Assessment of insulin utilization and insulin delivery metrics in people with type 1 diabetes mellitus using blood glucose excursions, combined with nutrition and exercise information from the T1-DEXI dataset

Lead Investigator: Eyal Dassau, Eli Lilly and Company
Title of Proposal Research: Assessment of insulin utilization and insulin delivery metrics in people with type 1 diabetes mellitus using blood glucose excursions, combined with nutrition and exercise information from the T1-DEXI dataset
Vivli Data Request: 8756
Funding Source: Researchers are employees of Eli Lilly and Company
Potential Conflicts of Interest:
Dr. Dassau reports: Currently works for Eli Lilly and Company – will not be applying for the grant
Conflicts of Interest (employment with Eli Lilly & Company) will be identified in all publications and disclosures
Dr. Chen reports: Currently works for Eli Lilly and Company – will not be applying for the grant
Conflicts of Interest (employment with Eli Lilly & Company) will be identified in all publications and disclosures
Dr. Winnie reports: Eli Lilly & Company
Conflicts of Interest (employment with Eli Lilly & Company) will be identified in all publications and disclosures
Note – Jennifer Winnie will not be one of the researchers analyzing or conducting the study and is not likely to be involved in publishing results
Dr. Johnson reports: Currently works for Eli Lilly and Company – will not be applying for the grant
Conflicts of Interest (employment with Eli Lilly & Company) will be identified in all publications and disclosures
Dr. Davidson reports: Works at Eli Lilly & Company – Not applying for the grant
Conflicts of Interest (employment with Eli Lilly & Company) will be identified in all publications and disclosures

Summary of the Proposed Research:

In the US, approximately 1.5 million people have Type 1 Diabetes, and are treated with insulin, either in form of Multiple Insulin Dose Therapy (MDI) or Continuous Subcutaneous Insulin Infusion (CSII). The majority of these are using Continuous Glucose Monitoring (CGM). Understanding the dosing behavior of people with Type 1 Diabetes is important both for individual assessment and for population studies.

Most studies of dosing behavior have been based on self-reported behavior, either retrospectively or based on patient logbooks. Some studies have applied algorithms to identify specific activities, but the strength of the various approaches is not thoroughly evaluated.

The study will evaluate multiple approaches to determine dosing behavior from the literature or not yet published. Such evaluation will strengthen research into patient behavior in real world studies by allowing for rational selection of methodologies. This will allow for a better understanding of patient insulin dosing behavior and various approaches to enhance therapy.

Requested Studies:

Type 1 Diabetes EXercise Initiative: The Effect of Exercise on Glycemic Control in Type 1 Diabetes Study
Data Contributor: Jaeb Center for Health Research Foundation, Inc.
Study ID: T1-DEXI
Sponsor ID: T1-DEXI

Type 1 Diabetes EXercise Initiative Pediatric Study (T1DexiP): The Effect of Exercise on Glycemic Control in Youth with Type 1 Diabetes
Data Contributor: Jaeb Center for Health Research Foundation, Inc.
Study ID: T1-DEXIP
Sponsor ID: T1-DEXIP