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Tracking Information | |||||||||
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First Received Date † | July 20, 2007 | ||||||||
Last Updated Date | January 5, 2009 | ||||||||
Start Date † | |||||||||
Current Primary Outcome Measures † |
Insulin secretion (C-peptide production) [ Time Frame: 1 year ] [ Designated as safety issue: No ] | ||||||||
Original Primary Outcome Measures † | Same as current | ||||||||
Change History | Complete list of historical versions of study NCT00505206 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † | Same as current | ||||||||
Descriptive Information | |||||||||
Brief Title † | Effect of Metabolic Control at Onset of Diabetes on Progression of Type 1 Diabetes | ||||||||
Official Title † | Effect of Metabolic Control at Onset of Diabetes on Progression of Type 1 Diabetes | ||||||||
Brief Summary | The aim of this study is to determine if early and tight restoration of metabolic control at the onset of Type 1 diabetes (T1DM) will improve insulin secretion (C-peptide production) versus routine diabetes management. |
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Detailed Description | There is evidence that early, intensive diabetes management may preserve C-peptide secretion possibly by allowing decreased islet cell activity or "islet cell rest". Less metabolically active islet cells result in a decreased inflammatory response and decreased autoantigen expression. This leads to a decrease in the destruction of beta cells and possibly to an increase in beta cell regeneration. In addition, the decreased hyperglycemia which results from intensive management may be less toxic to islet cells and make them less susceptible to cytokine mediated destruction. A closed-loop system (consisting of an in vivo glucose sensor, implantable insulin pump, and a feedback control algorithm to automatically determine insulin delivery rate) may optimally decrease the number of hours each day that islets are exposed to hyperglycemia. Used at the onset of T1DM, this may effectively decrease early "glucotoxicity" to allow earlier restoration of islet cell function, and perhaps alter islet antigen presentation to the immune system. The experimental therapy consists of a short course (minimum of 4 days) of closed-loop diabetic control at the onset of diabetes followed by continuous real-time glucose monitoring associated with continuous subcutaneous insulin infusion therapy (CSII) for two years. The standard therapy group will receive intensive management of their diabetes through frequent home glucose monitoring and multiple injections or CSII for two years. The implementation of any such therapy in this group will be determined by their treating diabetologist. |
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Study Phase | Phase II | ||||||||
Study Type † | Interventional | ||||||||
Study Design † | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study | ||||||||
Condition † | Type 1 Diabetes Mellitus | ||||||||
Intervention † |
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Study Arms / Comparison Groups |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status † | Not yet recruiting | ||||||||
Enrollment † | 108 | ||||||||
Completion Date | |||||||||
Primary Completion Date | |||||||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||||||
Ages | 3 Years to 20 Years | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts †† | |||||||||
Location Countries † | |||||||||
Expanded Access Status | |||||||||
Administrative Information | |||||||||
NCT ID † | NCT00505206 | ||||||||
Responsible Party | Ellen Leschek, Type 1 Diabetes TrialNet | ||||||||
Secondary IDs †† | |||||||||
Study Sponsor † | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | ||||||||
Collaborators †† | |||||||||
Investigators † |
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Information Provided By | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | ||||||||
Verification Date | January 2009 | ||||||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |