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Number of Subjects in Study Archive: 68
Study Design: Interventional
Conditions: Diabetes Mellitus, Diabetes Mellitus, Type 1
Division: DEM
Duration: September 2010 – November 2013
# Recruitment Centers: 5
Treatment: HCLC followed by SAP therapy
Available Genotype Data: No
Image Summary: No
Transplant Type: None
Does it have dialysis patients: No
Access to biospecimens for Effect of Metabolic Control at Onset of Diabetes on Progression of Type 1 Diabetes (TN12) is currently only available via collaboration. Please contact the parent study to ask about ancillary study opportunities.
Clinical Trials URL:
http://www.clinicaltrials.gov/show/NCT00891995
Study Website: https://www.trialnet.org/
Data Package Version Number: 1 (December 31, 2015)
DOI: 10.58020/hqfv-a985
How to cite this dataset: Krischer, Jeffrey (2023). Effect of Metabolic Control at Onset of Diabetes on Progression of Type 1 Diabetes (V1) [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 [(V1)/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/.
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.
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.
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: 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.
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.
Specimens and Study Datasets
| Plasma | 6012 |
| RNA | 5329 |
| Serum | 5042 |
| PB-PBMC | 3007 |
| Supernatant | 1064 |
| DNA | 249 |
| Forms |
 |
Data Dictionary (PDF) - 506.2 KB | |
| |
DSIC (PDF) - 349.8 KB | |
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Protocol (PDF) - 535.3 KB | |
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Roadmap (PDF) - 96.7 KB |
If you need accessible versions of documents, please email your request to NIDDK-CRsupport@niddk.nih.gov.
