Metabolic Phenotypes and Heterogeneity in Disease Burden Risk in Type 1 Diabetes (JDRF-COE)

This study focuses on individuals with type 1 diabetes (T1D) and seeks to comprehensively study and understand several aspects of T1D including: susceptibility to hypoglycemia (low blood sugar) and improvement in hypoglycemia risk using of advanced diabetes technologies, such as continuous glucose monitoring (CGM); the differences among individuals with T1D in the risk of chronic complications, and minimize the psychosocial impact of T1D.

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus

Detailed Description

The study seeks to comprehensively study and understand several aspects of type 1 diabetes (T1D) including: the risk of low blood sugar and how that may be improved with new technologies; the variability (heterogeneity) among individuals in their risk of diabetes complications, and factors that could impact the psychosocial burdens of having T1D. The investigators want to learn of there are patient-specific systemic metabolomic profiles (substances detected in blood or urine) that lower the risk for hypoglycemia. Metabolomic analyses will be used to discover biological markers that could predict who is most likely to get diabetes complications, and how these risks might be changed, for example, by developing treatments targeted specifically to those biological markers. The investigators also plan to describe the relationship between metabolomic profiles, psychosocial states and cognitive function.

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Rodica Pop-Busui, MD,PhD; Phone Number: 734-647-9809; Email: rpbusui@med.umich.edu
• Study Contact Backup: Name: Aimee Katona; Phone Number: 734-763-0177; Email: katona@med.umich.edu

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • University of Michigan
      • Contact: Aimee Katona; Phone Number: 734-763-0177; Email: katona@med.umich.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

All participants with type 1 diabetes previously enrolled and that participated in the University of Michigan T1D cohorts

Description

Inclusion Criteria:

• All participants with type 1 diabetes
• Previous enrollment and participation in the University of Michigan T1D cohorts (Natural History of Myocardial Dysfunction in T1D (HUM00036408); Targeting Inflammation with Salsalate in a T1D(HUM00169353); Preventing Early Renal Loss with Allopurinol in T1D (HUM00080944); and Tissue Specific Metabolic Reprogramming (HUM00060967)).
• Willing and able to participate in the study procedures described in the consent form.
• Willing to sign a written or electronic informed consent, including authorization to release health information.
• Fluent in spoken and written English.
• Willing to carry around their mobile phone/study mobile phone during the 14-day home monitoring period with daily access to cellular or WiFi connectivity.

Exclusion Criteria:

• Any social or medical condition that would, in the opinion of the Principal Investigator (PI), prevent complete participation in the study or would pose significant hazard to the subject's participation.
• Skin conditions or diseases that would interfere with the Continuous Glucose Monitor (CGM) sensor placement or accuracy (such as extensive psoriasis, extensive eczema, scarring, etc.)
• Scheduled X-ray, MRI, CT scan, or high-frequency electrical heat (diathermy) treatment during the period of CGM wear (or any other activity that would necessitate CGM sensor removal) that cannot be scheduled around or accommodated within the study assessment windows.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of enrolled participants providing serum samples for metabolomic analysis	Metabolomic samples will be requested from all study participants at the first (Visit 1) and last (Visit 3) study visit. The last study visit will be within 3 years of the first.	3 years

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: Juvenile Diabetes Research Foundation

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2021
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: November 1, 2022
• First Submitted That Met QC Criteria: November 1, 2022
• First Posted (Actual): November 8, 2022

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 11, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: diabetes; type-1 diabetes mellitus; endocrinology
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: HUM00185622

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No