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NCT02663661

Insulin-Glucose-Glucagon Network: Defining a Type 1 Diabetes Progression Index

Completed NA Last updated 23 July 2019
What this trial tests

NA trial testing Metabolic Challenge Admission in Diabetes Mellitus, Type 1 in 73 participants. Completed in 30 June 2019.

Timeline
16 March 2016
Primary endpoint
30 June 2019
30 June 2019

Quick facts

Lead sponsorUniversity of Virginia
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposeother
Enrollment73
Start date16 March 2016
Primary completion30 June 2019
Estimated completion30 June 2019
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Virginia

Who can join

Adults 12 to 45, any sex, with Diabetes Mellitus, Type 1. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The type 1 Diabetes (T1D) TrialNet Pathway To Prevention (PTP) Study assesses and recruits at-risk subjects into clinical trials aimed at preventing the development of full blown T1D. Thousands of first and second degree relatives of persons with T1D are screened for autoimmune abnormalities and positive subjects are followed with metabolic and autoantibody tests. The investigators' ancillary study us designed to test whether characterization of the insulin- glucose-glucagon (IGG) interactions in participants in the PTP study can provide new information about the early stages of the disease. When completed, this study will improve the understanding of the pathogenesis of the early stages of T1D and provide new quantitative tools for prediction and evaluation of insulin-glucagon-glucose interactions relevant to individuals at risk for developing T1D, thereby enabling future preventive intervention trials.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Predicting Immunological Risk for Stage 1 and Stage 2 Diabetes Using a 1-Week CGM Home Test, Nocturnal Glucose Increments, and Standardized Liquid Mixed Meal Breakfasts, with Classification Enhanced by Machine Learning.
    Montaser E, Breton MD, Brown SA, DeBoer MD, et al · · 2023 · cited 20× · PMID 37184602 · DOI 10.1089/dia.2023.0064
  2. Novel Detection and Progression Markers for Diabetes Based on Continuous Glucose Monitoring Data Dynamics.
    Montaser E, Farhy LS, Kovatchev BP. · · 2024 · cited 18× · PMID 38820084 · DOI 10.1210/clinem/dgae379

Verify or expand the search:

Other recruiting trials for Diabetes Mellitus, Type 1

Currently open trials in the same condition.

Other University of Virginia trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing