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| Sponsored by: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
|---|---|
| Information provided by: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| ClinicalTrials.gov Identifier: | NCT00505206 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Type 1 Diabetes Mellitus |
Device: CSII and CGM Other: Standard Treatment |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Effect of Metabolic Control at Onset of Diabetes on Progression of Type 1 Diabetes |
| Estimated Enrollment: | 108 |
| Study Start Date: | June 2009 |
| Arms | Assigned Interventions |
|---|---|
|
1. CSII and CGM: Experimental
Initial, short course of Continuous Subcutaneous Insulin Infusion therapy (CSII) and followed by real-time continuous glucose monitoring (rtCGM)associated with CSII for two years.
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Device: CSII and CGM
The experimental therapy consists of a short course of subcutaneous closed-loop diabetic control at the onset of diabetes followed by real-time continuous glucose monitoring (rtCGM) associated with continuous subcutaneous insulin infusion otherapy (CSII) for two years.
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2, Standard Insulin Treatment: Active Comparator
THe standard treatment will consist of multiple daily insulin injections (3-4 insulin injections per day) to maintain normal glycemic control.
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Other: Standard Treatment
Multiple daily insulin injections will be required as standard treatment
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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.
Eligibility| Ages Eligible for Study: | 3 Years to 20 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| Stanford University | Recruiting |
| Stanford, California, United States, 94305-5208 | |
| Contact: Jennifer Block, RN 650-736-8142 jenblock@stanford.edu | |
| Principal Investigator: Bruce Buckingham, MD | |
| United States, Connecticut | |
| Yale University Medical Center | Recruiting |
| New Haven, Connecticut, United States | |
| Contact: Amy Steffen, RN Amy.steffen@yale.edu | |
| Principal Investigator: Stuart Weinzimer, MD | |
| Study Chair: | Jay Skyler, MD | University of Miami |
More Information
| Responsible Party: | Type 1 Diabetes TrialNet ( Ellen Leschek ) |
| Study ID Numbers: | EMCO |
| Study First Received: | July 20, 2007 |
| Last Updated: | August 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00505206 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Beta-cell function closed-loop diabetic control tight metabolic control continuous subcutaneous insulin infusion therapy continuous real-time glucose monitoring DPT-1 treatment |
treatment of type 1 diabetes new onset type 1 diabetes juvenile diabetes T1D diabetes mellitus Type 1 diabetes TrialNet TrialNet |
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Autoimmune Diseases Metabolic Diseases Diabetes Mellitus, Type 1 Disease Progression Diabetes Mellitus Endocrine System Diseases |
Diabetes Mellitus Type 1 Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder Insulin |
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Autoimmune Diseases Metabolic Diseases Immune System Diseases Diabetes Mellitus, Type 1 |
Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders |
