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Effect of CSII and CGM on Progression of Late Diabetic Complications Fase IV 60

Concluído
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O estudo clínico NCT01454700 avaliou tratamento para Diabetes mellitus tipo 1. Foi um estudo intervencionista de Fase IV. Seu status atual é: concluído. O estudo iniciou em 1 de dezembro de 2011 e incluiu 60 participantes. Coordenado por Steen Andersen e foi concluído em 1 de dezembro de 2014. Essas informações foram atualizadas no ClinicalTrials.gov em 14 de janeiro de 2015.
Resumo
The purpose of the study is to investigate whether the combination of insulin pump therapy and continued glucose monitoring (CGM) is superior to multiple daily insulin injections to prevent progression of albuminuria in patients with type 1 diabetes
Descrição detalhada
80 type 1 diabetic patients with kidney function (GFR > 45 ml/min), but with urine albumin excretion of at least 30 mg/day and HbA1c 7.5-13.0% are randomised to either multiple daily insulin injections (control group) or insulin pump therapy plus continued glucose monitoring (CGM) (intervention group). Patients must be in stable RAAS blockade before entering the study.

Before the study is initiated all patients rec...

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Título oficial

The Effect of Sensor-Augmented Continuous Subcutaneous Insulin Infusion Compared to Multiple Daily Insulin Injections in Prevention of Increasing Urinary Albumin Excretion Rate in Type 1 Diabetes Mellitus

Condições médicas
Diabetes mellitus tipo 1
Publicações
Artigos científicos e trabalhos de pesquisa publicados sobre este estudo clínico:
Outros IDs do estudo
  • H-3-2011-122
Número NCT
NCT01454700
Data de início (real)
2011-12
Última atualização postada
2015-01-14
Data de conclusão (estimada)
2014-12
Inscrição (estimada)
60
Tipo de estudo
Intervencionista
FASE
Fase IV
Status
Concluído
Palavras-chave
Type 1 diabetes mellitus
Albuminuria
Late diabetes complications
CSII
CGM
Glycaemic control
Propósito principal
Tratamento
Alocação do design
Randomizado
Modelo de intervenção
Paralelo
Cegamento (Mascaramento)
Nenhum (Aberto)
Braços / Intervenções
Grupo de participantes/BraçoIntervenção/Tratamento
ExperimentalCSII plus CGM
Patients who has never been treated with insulin pump are randomized to 12 months with insulin pump therapy plus continuous glucose monitoring.
Insulin pump therapy (CSII) plus continuous glucose monitoring (CGM)
Randomization to 12 months with CSII plus CGM
Comparador ativoMultiple daily insulin injections
randomized to 12 months standard/usual insulin regimen (multiple daily injections). (stays on insulin pen).
Multiple daily insulin injections (MDI)
Randomization12 months therapy with MDI
Desfecho primário
Medida de desfechoDescrição da medidaPrazo
difference in change in urine albumine excretion from baseline to end of study (12 months)
Urine albumin excretion is evaluated at screening, at entry, after 1,3,6,9, and 12 months.
12 months
Desfecho secundário
Medida de desfechoDescrição da medidaPrazo
difference in change of HbA1c from baseline to 12 months
12 months
difference in change in self-monitored blood glucose (SMBG) measurement 4-point glucose profiles
12 months
difference in change of 24-hour blood pressure
12 months
difference in change of glomerular filtration rate (GFR)
12 months
difference in the occurence or progression of retinopathy
12 months
difference in change of cardiovascular biomarkers of inflammation, lipid metabolism and NT-proBNP
12 months
difference in endothelial cell dysfunction
12 months
difference in carotid intima media thickness (CIMT)
12 months
Critérios de elegibilidade

Idades elegíveis
Adulto, Idoso
Idade mínima
18 Years
Sexos elegíveis
Todos
  • 18-75 years of age,
  • Type 1 diabetes according to WHO criteria,
  • Urin albumine > 30 mg/g (albumine/creatinine ratio),
  • HbA1c > 7.5 < 13.0%,
  • No change in RAAS blocking treatment at least 4 weeks prior to screening.

  • Kidney disease other that diabetic nephropathy,
  • Recurrence of severe hypoglycaemia or hypoglycaemia unawareness as judged by the investigator,
  • Use of insulin pump within 12 months,
  • Acute myocardial infarction within 3 months,
  • Severe arteriosclerosis as judged by the investigator,
  • Heart failure (NYHA class 3 or 4),
  • Abuse of alcohol or drugs,
  • Any cancer diagnosis unless in remission at least 5 years prior to screening,
  • Participation in other intervention studies,
  • Pregnant or lactating women,
  • Any other disease, condition or type of treatment which - as judged by the investigator - render the patient ineligible to participate in the study.
Steen Andersen logoSteen Andersen
Medtronic logoMedtronic
Responsável pelo estudo
Steen Andersen, Patrocinador-Investigador, Chief physician, DMSc, Steno Diabetes Center Copenhagen
Sem dados de contato.
1 Locais do estudo em 1 países

Copenhagen

Steno Diabetes Center, Gentofte Municipality, Copenhagen, 2820, Denmark