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CompletedNCT05609279JDRF-COEUpdated Dec 13, 2024

Metabolic Phenotypes and Heterogeneity in Disease Burden Risk in Type 1 Diabetes

An observational study in Diabetes Mellitus, sponsored by University of Michigan. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2024-12-13.

Sponsored by University of Michigan · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Diabetes Mellitus

Keywords

  • diabetes
  • type-1 diabetes mellitus
  • endocrinology
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In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 60 is below the median of 233 across 2,220 observational studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

University of Michigan is the lead sponsor of 1,475 studies on the registry; 196 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 128 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
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

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

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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3 years

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Study locations

1 site
  • University of Michigan
    Ann Arbor, Michigan 48109, United States
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 13, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05609279
Lead sponsor
University of Michigan
Collaborators
Juvenile Diabetes Research Foundation
Responsible party
Rodica Pop-Busui (Professor of Internal Medicine, University of Michigan) — Principal investigator
First posted
Nov 8, 2022
Start date
Feb 18, 2021
Primary completion
Aug 30, 2024
Completion
Aug 30, 2024
Last update
Dec 13, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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