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Citation
Krischer, Jeffrey (2022). Long-Term Investigative Follow-Up in TrialNet Study (TN16) (Version 2) [Dataset] NIDDK Central Repository. https://doi.org/10.58020/w3gs-0421
Data Availability Statement
Data from the Long-Term Investigative Follow-Up in TrialNet Study (TN16) [(Version 2) https://doi.org/10.58020/w3gs-0421] reported here are available for request at the NIDDK Central Repository (NIDDK-CR) website, Resources for Research (R4R), https://repository.niddk.nih.gov/.
Acknowledgement Statement
This research was performed using resources generated by the Type 1 Diabetes TrialNet Study Group, a clinical trials network funded through a cooperative agreement by the National Institutes of Health (NIH) through the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the National Institute of Allergy and Infectious Diseases (NIAID), the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), and the Juvenile Diabetes Research Foundation (JDRF) and supplied by NIDDK Central Repository (NIDDK-CR). This manuscript was not prepared under the auspices of the TrialNet network and does not necessarily represent the opinions or views of TrialNet, NIDDK-CR, or NIH.
Data Package Version
Version 2 (Updated on: Jun 09, 2022)
Resource Availability
  • Data Available for Request
  • Specimens Require Collaboration with Parent Study
Publications
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View publications (1)

General Description

The LIFT Study is available nationwide to TrialNet participants who either:

  • Developed diabetes while being monitored in the Pathway to Prevention Study or during participation in any prevention trial. The purpose is to study people early in the disease process

  • Participated in any new onset studies. The purpose is to learn more about diabetes and if there are any long-term effects—good or bad—from the treatments used in these studies

Participants will be asked to return to a TrialNet site annually or semi- annually, based on their ongoing ability to produce insulin. Visits will include metabolic testing (i.e., Oral Glucose Tolerance Test and/or Mixed Meal Tolerance Test), HbAc1, and possibly other blood or urine tests.

Objectives

To study subjects early in the Type 1 Diabetes process, and to study if there are any long-term effects from the treatments used in previous new onset studies.

Eligibility Criteria

Inclusion Criteria:

  • Subjects that were previously enrolled in a TrialNet study for people newly diagnosed with type 1 diabetes

  • Subjects that developed type 1 diabetes while participating in the Pathway to Prevention Study or a TrialNet prevention study.

Outcome

This study is ongoing.

Research Area

Diabetes

Study Type

Observational

Condition

Type 1 Diabetes Mellitus

Keywords

Diabetes Mellitus, Type 1

NIDDK Division

Division of Diabetes, Endocrinology, and Metabolic Diseases

547
Participants

Target Population
Adults, Children

Public Documents Table
Document Name
Description
Document Type
File Format
Compliance
Download
TN16 Data Challenge Data Dictionary V1
Data Challenge Data Dictionary used as a collection of metadata - defines the variable contents of each SAS dataset (V1)Codebook/Data DictionaryPDF
TN16 Data Dictionary V2
Data Dictionary used as a collection of metadata - defines the variable contents of each SAS dataset (V2)Codebook/Data DictionaryPDF
TN16 Data Dictionary V2 Screen Reader Version
Data Dictionary (Screen Reader Version) used as a collection of metadata - defines the variable contents of each SAS dataset (V2)Codebook/Data DictionaryPDF

Non-Public Documents (0)
There are currently no non-public documents available
Datasets (13)
Datasets Table
Dataset Name
Description
# of Records
# of Variables
File Format(s)
Change of Status Dataset
Captures data on change of participant enrollment status306sas7bdat (1.5 MB); csv (49.38 KB)
Variable Names
  • MaskID
  • Visit_Dt
  • Visit
  • DateStatusChangeDay
  • DateStatusChangeMonth
  • DateStatusChangeYear
  • ChangeOfStatusOccuring
  • DoWDay
  • DoWMonth
  • DoWYear
  • ReasonForWithdrawal
  • ReasonAdverseEventSpecify
  • ReasonWithdrewConsentSpecify
  • ReasonForWithdrawalOTHER
  • WillingToBeContacted
  • DoRDay
  • DoRMonth
  • DoRYear
  • DateCompletionDD
  • DateCompletionMM
  • DateCompletionYYYY
  • IsParticipantWillingBeContacte
  • ParticipantCompletedEntireStud
  • WillingToContinueAfterPregnanc
  • WithdrewConsentWhy
  • WithdrewConsentWhyIfOther
  • LastAttendedVisitMonth
  • PregnancyCompletionMonth
  • PregnancyCompletionDay
  • PregnancyCompletionYear
  • LastAttendedVisitDay
  • LastAttendedVisitYear
  • PhiX174VisitNumber
Adverse Events Review Dataset
Data collected on the review of adverse event information7sas7bdat (1 MB); csv (912 B)
Adverse Events Dataset
Any unfavorable and unintended sign, symptom, or disease associated with medical treatment or procedure18sas7bdat (1 MB); csv (10.54 KB)
Protocol Deviations Dataset
Protocol deviation procedures recorded during participant visits186sas7bdat (1.48 MB); csv (63.29 KB)
Eligibility Form Dataset
Eligibility form data describing participant consent and involved trial557sas7bdat (1 MB); csv (46.49 KB)
Participant Registration Dataset
Data collected on participant registration and status561sas7bdat (1 MB); csv (21.34 KB)
Concomitant Medication Data Dataset
Information data regarding type of medication, amount of medication, indication, etc.1538sas7bdat (2.5 MB); csv (167.7 KB)
Permanent Site Transfer Dataset
Data collected on participant permanent site transfer and reason for transfer48sas7bdat (1 MB); csv (5.96 KB)
Diabetes Health Information Dataset
Data collected on the health information of participants with diabetes2596sas7bdat (3.45 MB); csv (545.09 KB)
Physical Exam Dataset
Data collected on physical exam performed on patient2sas7bdat (1 MB); csv (797 B)
Research Labs Dataset
Specimen collection, test results, and sample identification data38895sas7bdat (61 MB); csv (5.81 MB)
Protocol Versions Used Dataset
Specific protocol versions used during participant visits636sas7bdat (1 MB); csv (25.93 KB)
Health Status Request Dataset
Captures data on participant health status31sas7bdat (1 MB); csv (12.03 KB)
Specimens (30,745)
Specimens Table
Specimen
Count
PB-PBMC9306
Plasma13552
Serum4889
Whole Blood2998