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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)
Resource Availability
  • Data Available for Request
  • Specimens Require Collaboration with Parent Study
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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.

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

Eligibility 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

Study Start Date

2010-09

Study End Date

2013-10

Condition

Type 1 Diabetes Mellitus

Keywords

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

NIDDK Division

Division of Diabetes, Endocrinology, and Metabolic Diseases

71
Participants

Target Population
Children, Adults

Public Documents Table
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Document Type
File Format
Compliance
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Datasets (27)
Datasets Table
Dataset Name
Description
# of Records
# of Variables
File Format(s)
Troster Dataset
Captures data on participant randomization71sas7bdat (24 KB); csv (5.37 KB)
Lab Results Dataset
Captures data on laboratory results9357sas7bdat (1.02 MB); csv (587.52 KB)
Contacts Dataset
Captures data on participant vital signs and laboratory results463csv (60.54 KB); sas7bdat (104 KB)
CGM Sensor Dataset
Captures CGM data during closed loop - loaded from Medtronic spreadsheet file218490sas7bdat (10.12 MB); csv (10.07 MB)
Hypoglycemic Events Child Form Dataset
Contains data from completed Hypoglycemic Events Child Form 89sas7bdat (24 KB); csv (5 KB)
Insulin Dataset
Captures data on insulin delivery during closed loop - loaded from Medtronic spreadsheet file44005sas7bdat (1.38 MB); csv (1.42 MB)
Enrollment Hx Form Dataset
Contains data from completed Enrollment Hx Form 71sas7bdat (40 KB); csv (15.21 KB)
CGM Dataset
Captures data on FT-CGM sensor reading per patient and device5101952sas7bdat (511.04 MB); csv (352.24 MB)
HbA1c Form Dataset
Contains data from completed HbA1c Form 649sas7bdat (64 KB); csv (27.71 KB)
Active Dataset
Captures data on automatic control intervals of closed-loop system - loaded from Medtronic spreadsheet file320csv (14.92 KB); sas7bdat (24 KB)
Skin Assessment Form Dataset
Contains data from completed Skin Assessment Form 475sas7bdat (64 KB); csv (19.52 KB)
Concomitant Medications Form Dataset
Contains data from completed Concomitant Medications Form 61sas7bdat (32 KB); csv (6.72 KB)
Follow-Up Hx Form Dataset
Contains data from completed Follow-Up Hx Form 647sas7bdat (80 KB); csv (51.76 KB)
Adverse Event Form dataset
Contains data from completed Adverse Event Form28csv (7.02 KB); sas7bdat (40 KB)
CGM Sensor Use Form Dataset
Contains data from completed CGM Sensor Use Form 465sas7bdat (128 KB); csv (46.15 KB)
Glucose Indices Dataset
Captures data on glucose laboratory results362csv (39.96 KB); sas7bdat (72 KB)
Closed Loop Therapy Form Dataset
Contains data from completed Closed Loop Therapy Form 50sas7bdat (16 KB); csv (1013 B)
Meal Dataset
Captures meal data during closed loop - loaded from Medtronic spreadsheet file1027sas7bdat (96 KB); csv (53.12 KB)
Pre-Existing Conditions Form Dataset
Contains data from completed Pre-Existing Conditions Form 71sas7bdat (56 KB); csv (21.12 KB)
Insulin Management Form Dataset
Contains data from completed Insulin Management Form 647sas7bdat (200 KB); csv (107.38 KB)
Reference Glucose Dataset
Captures reference glucose data during closed loop - loaded from Medtronic spreadsheet file7610sas7bdat (744 KB); csv (447.41 KB)
Non Protocol Visits Form Dataset
Contains data from completed Non Protocol Visits Form 18sas7bdat (16 KB); csv (1.42 KB)
Hypoglycemic Hyperglycemic Events Form Dataset
Contains data from completed Hypoglycemic Hyperglycemic Events Form 50sas7bdat (16 KB); csv (1.29 KB)
Subjects Dataset
Captures miscellaneous data on study subjects68sas7bdat (24 KB); csv (11.01 KB)
Mixed Meal Tolerance Form Dataset
Contains data from completed Mixed Meal Tolerance Form 623sas7bdat (152 KB); csv (76.68 KB)
Admission Discharge Form Dataset
Contains data from completed Admission Discharge Form 50sas7bdat (24 KB); csv (7.24 KB)
Hyperglycemic Events Child Form Dataset
Contains data from completed Hyperglycemic Events Child Form 86sas7bdat (24 KB); csv (5.12 KB)
Specimens (20,703)
Specimens Table
Specimen
Count
DNA249
PB-PBMC3007
Plasma6012
RNA5329
Serum5042
Supernatant1064