Effect of Metabolic Control at Onset of Diabetes on Progression of Type 1 Diabetes
9 novembre 2016 mis à jour par: Jaeb Center for Health Research
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.
Aperçu de l'étude
Statut
Résilié
Les conditions
Description détaillée
The specific aim of this study is to determine if early restoration of metabolic control will improve C-peptide production compared to children receiving routine diabetes management and the secondary aim is to determine if allowing the islet cells to be less metabolically active will have an impact on the underlying autoimmune process.
Following completion of the baseline procedures (Mixed Meal Tolerance Test and blood sample collection), participants are randomized to either the Standard Treatment Group or the Intensive Treatment Group which includes 4-6 days of inpatient closed loop therapy followed by outpatient use of an insulin pump and continuous glucose monitor for diabetes management.
All subjects will be seen 7 times in the first year and 4 times in the second year for follow-up testing. Subjects who are still producing insulin after 2 years may be asked to return every 6 months for an additional 2 years.
Type d'étude
Interventionnel
Inscription (Réel)
71
Phase
- Phase 2
- Phase 3
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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California
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Stanford, California, États-Unis, 94305
- Stanford University
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Colorado
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Aurora, Colorado, États-Unis, 80010
- Barbara Davis Center for Childhood Diabetes
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Connecticut
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New Haven, Connecticut, États-Unis, 06519
- Yale University
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Indiana
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Indianapolis, Indiana, États-Unis, 46202
- Indiana University
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Tennessee
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Nashville, Tennessee, États-Unis, 37232
- Vanderbilt University
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
6 ans à 45 ans (Enfant, Adulte)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Age 6.0 to <46.0 years
- Diagnosis of type 1 diabetes with initiation of insulin therapy within past 7 days (day 1 being the first day of insulin therapy)
- If participant is female with reproductive potential, willing to avoid pregnancy and pregnancy test negative.
- Willing to accept randomization to either the intensive diabetes management group or the standard care group.
- Willing to complete the planned 2 years of follow-up.
- Able to electronically transmit data monthly.
- Investigator believes that the participant (and parent/guardian for children) understands and agrees to comply with the study protocol and is capable of undertaking all necessary testing.
Exclusion Criteria:
- Currently pregnant or lactating, or anticipate getting pregnant in the next one year.
- Currently anemic (hematocrit level will be obtained at the screening visit).
- Chronic use of systemic steroids or other noninsulin pharmaceuticals that might affect glycemic control or the presence of a disease that is likely to be treated with such medications during the first two years of the study.
- Complicating medical issues that might interfere with study conduct.
- Inpatient psychiatric treatment in the past 6 months (if the participant is a minor, for either the participant or the participant's primary care giver).
- Currently participating in another type 1 diabetes treatment study, including an intervention trial for treatment of diabetic ketoacidosis.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Intensive Treatment
closed loop therapy (4-6 days), insulin pump (2 years), continuous glucose monitoring (2 years), home glucose monitoring (2 years)
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Closed loop therapy for up to 4 to 6 days
Standard diabetes management using a home glucose meter.
Insulin pump use for 2 years
Continuous glucose monitor use for 2 years
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Comparateur actif: Standard Treatment
home glucose monitoring (2 years)
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Standard diabetes management using a home glucose meter.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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C-peptide Average Area Under the Curve (AUC) in Response to a Mixed Meal at 1 Year Following Enrollment.
Délai: At baseline, MMTT data were collected at 0 and 90 min; at 12 months, MMTT data were collected at 0 to 240 min post meal
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In the primary analysis of the 12-month Mixed-Meal Tolerance Test (MMTT) results, the geometric mean (95% C.I.) of C-peptide average AUC (=AUC/time) was 0.43 (0.34, 0.52) pmol/ml in the intensive treatment group and 0.52 (0.32, 0.75) pmol/ml in the usual care group (P=0.49).
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At baseline, MMTT data were collected at 0 and 90 min; at 12 months, MMTT data were collected at 0 to 240 min post meal
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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HbA1c
Délai: 1 an
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1 an
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Peak C-peptide in Response to a Mixed Meal at 1 Year Following Enrollment
Délai: 0 to 240 min post meal at 1 year MMTT
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0 to 240 min post meal at 1 year MMTT
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Incidence of the Loss of the 2 Hour Peak C-peptide < 0.2 Pmol/ml on a Semi-annual MMTT
Délai: 0 to 240 min post meal at 1 year MMTT
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Outcome measure in the table is the incidence of 2 hour peak C-peptide>=0.2
pmol/ml.
Since the formal clinical trial stopped at 12 months due to lack of efficiency (later follow-up were used to collect data for secondary analyses by pooling the two groups), only the outcome at 12 months are reported.
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0 to 240 min post meal at 1 year MMTT
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Adverse Events (Severe Hypoglycemia)
Délai: 1 year
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1 year
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CGM Mean Glucose
Délai: 1 year
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1 year
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CGM Measured Glucose Outcomes
Délai: 1 year
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Include a series of glucose indices created from CGM measured glucose data, such as % time with glucose values <=70 mg/dl, % time with glucose values within target range of 71-180 mg/dl, % time with glucose values >180 mg/dl, and glucose variability as measured by coefficient of variation.
These indices were calculated by giving equal weight to each of the 24 h of the day.
At least 24 h of CGM data were required for calculating these indices.
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1 year
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Daily Insulin Dose
Délai: 1 year
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1 year
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BMI Percentile
Délai: 1 year
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1 year
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Jay S. Skyler, M.D., M.A.C.P., University of Miami
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- Buckingham B, Beck RW, Ruedy KJ, Cheng P, Kollman C, Weinzimer SA, DiMeglio LA, Bremer AA, Slover R, Tamborlane WV; Diabetes Research in Children Network (DirecNet) Study Group; Type 1 Diabetes TrialNet Study Group. Effectiveness of early intensive therapy on beta-cell preservation in type 1 diabetes. Diabetes Care. 2013 Dec;36(12):4030-5. doi: 10.2337/dc13-1074. Epub 2013 Oct 15.
- Diabetes Research in Children Network (DirecNet) Study Group; Type 1 Diabetes TrialNet Study Group; Buckingham BA, Beck RW, Ruedy KJ, Cheng P, Kollman C, Weinzimer SA, DiMeglio LA, Bremer AA, Slover R, Cantwell M. The effects of inpatient hybrid closed-loop therapy initiated within 1 week of type 1 diabetes diagnosis. Diabetes Technol Ther. 2013 May;15(5):401-8. doi: 10.1089/dia.2013.0002. Epub 2013 Apr 9.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 septembre 2010
Achèvement primaire (Réel)
1 octobre 2013
Achèvement de l'étude (Réel)
1 octobre 2013
Dates d'inscription aux études
Première soumission
30 avril 2009
Première soumission répondant aux critères de contrôle qualité
30 avril 2009
Première publication (Estimation)
1 mai 2009
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
30 décembre 2016
Dernière mise à jour soumise répondant aux critères de contrôle qualité
9 novembre 2016
Dernière vérification
1 novembre 2016
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- DirecNet 012
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .