An official website of the United States government

This repository is under review for potential modification in compliance with Administration directives.
Citation
Krischer, Jeffrey (2015). Effect of Metabolic Control at Onset of Diabetes on Progression of Type 1 Diabetes (TN12) (Version 1) [Dataset] NIDDK Central Repository. https://doi.org/10.58020/hqfv-a985
Data Availability Statement
Data from the Effect of Metabolic Control at Onset of Diabetes on Progression of Type 1 Diabetes (TN12) [(Version 1) https://doi.org/10.58020/hqfv-a985] 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 1 (Updated on: Dec 31, 2015)
Publications
Explore publications resulting from the use of study resources
View publications (0)

General Description

The purpose of this study is to find out if very tight blood glucose control from the onset of Type 1 Diabetes can preserve beta cell function. Study subjects will be randomly assigned to receive either standard diabetes management or intensive diabetes management, which involves several days of closed loop therapy followed by home use of a continuous glucose monitor and insulin pump.

Primary Objectives

To asses effectiveness of inpatient hybrid closed-loop control (HCLC) followed by outpatient sensor-augmented pump (SAP) therapy initiated within 7 days of diagnosis of type 1 diabetes on the preservation of β-cell function at one year.

Outcome Measure

Primary Outcome Measures: C-peptide area under the curve in response to a mixed meal at 1 year following enrollment.

Secondary Outcome Measures: incidence of the loss of the 2 hour peak C-peptide < 0.2 pmol/ml on a semi-annual MMTT

Inclusion Criteria

Inclusion: Patients must be between the ages of 6 and <46 with a diagnosis of Type 1 Diabetes with initiation of insulin therapy within the past 7 days to participate in this study.

Exclusion: Patients under the age of 6 or over the age of 45, who are pregnant, nursing, or plan to get pregnant in the next year will not be able to participate in this study.

Outcome

In new-onset type 1 diabetes, HCLC followed by SAP therapy did not provide benefit in preserving β-cell function compared with current standards of care.

Research Area

Diabetes

Study Type

Interventional

Study Sites

5

Condition

Type 1 Diabetes Mellitus

Medication or Intervention Agent

Continuous Subcutaneous Infusion of Insulin, Insulin, Closed-Loop Insulin Infusion System, Insulin Pump, Continuous Glucose Monitoring System

Procedure

None

Keywords

Beta Cell Function, Hybrid Closed-Loop Control, Diabetes Mellitus, Type 1, HCLC, C-Peptide, SAP Therapy, Sensor-Augmented Pump

NIDDK Division

Division of Diabetes, Endocrinology, and Metabolic Diseases (DEM)

There are currently no public documents available

Permitted Use(s) of the Resources
  • Use is allowed only for the specified disease(s), disorder(s), condition(s), or research area(s): Type 1 Diabetes Mellitus; Related Complications

Certificate of Confidentiality
  • This NIDDK-funded study is covered by a Certificate of Confidentiality. More information on what this means to Requestors is available in the NIH FAQ.

Non-Public Documents (0)
There are currently no non-public documents available
Datasets (0)
There are currently no datasets available
Specimens (41,384)
Specimens Table
Specimen
Count
DNA498
PB-PBMC5990
Plasma12024
RNA10658
Serum10086
Supernatant2128