MD Logic Pump Advisor- Adults Study
Evaluation of Automated Insulin Pump Settings Using the MD-Logic Pump Advisor-Adults Sub Study
Prospective, randomized, controlled, 30-78 days trial comparing MD-Logic pump algorithm to the standard of care of patients with type 1 diabetes.
The objective of this feasibility study is to evaluate the efficacy and safety of automated determined Insulin pump settings (i.e., basal plan, correction factor, carbohydrate ration and insulin activity time) using the MD-Logic Pump Advisor in individuals with type 1 diabetes.The study will be consisted from two segments:(I)pilot study, 30-78 days trial evaluating the MD-Logic pump advisor and (II)randomized controlled 30-78 days trial comparing MD-Logic pump algorithm to the standard of care.In segment 1, the pilot study, the aim is to enroll 15-30 subjects without control group. In segment 2, the randomized controlled segment, the aim is to enroll 92 subjects, but enrolling up to 105 eligible subjects to allow for dropouts.
The randomized controled study segment will be initiated after the pilot segment.Each segment of the study will consist of 6 clinic visits taking place at intervals of 1-3 weeks, sum of 30-78 days study duration for each segment. Before each clinic visit, subjects will wear continuous glucose sensors for 6 days; the intervention group will have up to 4 iterations (e.g the pump setting will be reviewed and adjusted up to 4 times during the study period according to the MD-Logic Pump Advisor).For the control group (at segment 2 only), insulin pump settings will not be changed during the study period (patient's usual standard of care).
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
the MD-Logic Pump Advisor was design by the Diabetes Technology Center, the Institute of Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children's Medical Center of Israel. The MD-Logic Pump Advisor learns and adapts the patient's insulin pump settings in order to optimize glucose control. The MD-Logic Pump Advisor needs, as input, sensor readings, insulin delivery and recording of the meals during home care. During collection of the data, the patients are asked to continue their daily routine (no need for special consideration).
The present study was designed to test the automatic algorithm that will evaluate and change, when necessary, the patient's insulin pump settings based on prior sensor reading, insulin delivery, and meals data that was collected while the patient is under his regular treatment at home.
The objective of this feasibility study is to evaluate the efficacy and safety of automated determined Insulin pump settings (i.e., basal plan, correction factor, carbohydrate ration and insulin activity time) using the MD-Logic Pump Advisor in individuals with type 1 diabetes.
The study will be consisted from two segments:(I)pilot study, 30-78 days trial evaluating the MD-Logic pump advisor and (II)randomized controlled 30-78 days trial comparing MD-Logic pump algorithm to the standard of care.In segment 1, the pilot study, the aim is to enroll 15-30 subjects without control group. In segment 2, the randomized controlled segment, the aim is to enroll 92 subjects, but enrolling up to 105 eligible subjects to allow for dropouts.
The randomized controled study segment will be initiated after the pilot segment.Each segment of the study will consist of 6 clinic visits taking place at intervals of 1-3 weeks, sum of 30-78 days study duration for each segment. Before each clinic visit, subjects will wear continuous glucose sensors for 6 days; the intervention group will have up to 4 iterations (e.g the pump setting will be reviewed and adjusted up to 4 times during the study period according to the MD-Logic Pump Advisor).For the control group (at segment 2 only), insulin pump settings will not be changed during the study period (patient's usual standard of care).
Endpoints:
- Primary endpoint Increase in time spent in the normal range, defined as sensor glucose level within 70 to 180 mg/dl
- Secondary endpoints Reduced time spent above 180 mg/dl, reduced time spent below 70 mg/dl, reduced number of hypoglycemic events below 63 mg/dl, reduced glucose variability, quality of life measurements and subject treatment satisfaction.
Inclusion Criteria:
- Subject with Type 1 diabetes (>1yr since diagnosis)
- Medtronic ( MiniMed Paradigm 522, 512 , 722 or 712) insulin infusion pump CSII (continuous subcutaneous insulin infusion) therapy for at least 3 months
- Age ≥ 18 years
- HbA1c at inclusion ≥ 6.0%
- No concomitant diseases that influence metabolic control
- No current use of CGM
- Subjects do not participate in any other interventional study
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Subject with Type 1 diabetes (>1yr since diagnosis)
- Medtronic( MiniMed Paradigm 522, 512 , 722 or 712) insulin infusion pump CSII therapy for at least 3 months
- Age ≥ 18 years
- HbA1c at inclusion ≥ 6.0%
- No concomitant diseases that influence metabolic control
- No current use of CGM
- Subjects do not participate in any other interventional study
Exclusion Criteria:
- Known or suspected allergy to trial products.
- Any significant diseases or conditions including psychiatric disorders and substance abuse that, in the opinion of the investigator, is likely to affect the subject's ability to complete the study, or compromise patient safety
- Subject is currently using CGM device
- Diabetic ketoacidosis in the past 3 months.
- Severe hypoglycemia resulting in seizure or loss of consciousness in the month prior to enrollment.
- Current use of oral glucocorticoids or other medications, which in the judgment of the investigator would be a contraindication to participation in the study.
- Subject is participating in another drug or device study that could affect glucose measurements or glucose management.
- Female subject who is pregnant or planning to become pregnant within the planned study duration
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: intervantion group
Insulin pump settings (i.e., basal plan, correction factor, carbohydrate ration and insulin activity time) will be adjusted using the MD-Logic Pump Advisor.
|
Insulin pump settings (i.e., basal plan, correction factor, carbohydrate ration and insulin activity time) will be adjusted using the MD-Logic Pump Advisor
|
|
Sem intervenção: control group
Regular treatment, No change will be made in the insulin pump setting during the study(unless there is a medical need or any safety concern).
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Time spent in the normal range
Prazo: during each 6 days iteration
|
increase in the time spent in the normal range, defined as sensor glucose level within 70-180 mg/dl
|
during each 6 days iteration
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
number of iterations required to achieve the maximal meaningful improvement in the primary outcome
Prazo: Day 78
|
number of iterations required to achieve the maximal meaningful improvement in the primary outcome
|
Day 78
|
|
time spent above 180 mg/dl
Prazo: during each 6 days iteration
|
time spent above 180 mg/dl
|
during each 6 days iteration
|
|
time spent below 70 mg/dl
Prazo: during each 6 days iteration
|
time spent below 70 mg/dl
|
during each 6 days iteration
|
|
Number of Hypoglycemic events below 63 mg/dl
Prazo: during each 6 days iteration
|
Number of Hypoglycemic events below 63 mg/dl
|
during each 6 days iteration
|
|
Adverse event
Prazo: during each 6 days iteration
|
Adverse event
|
during each 6 days iteration
|
|
glucose variability- area under the curve
Prazo: during each 6 days iteration
|
glucose variability measured as area under the curve (the area between the measured blood glucose and the glucose level of 180 mg/dl) and area above the curve (the area between the measured blood glucose and the glucose level of 70 mg/dl
|
during each 6 days iteration
|
|
Quality of Life Questionaires
Prazo: At the end of the study- day 30 -78
|
Quality of Life Questionaires
|
At the end of the study- day 30 -78
|
|
Number of MDLAP-recommendations that were rejected by the physician
Prazo: during each 6 days iteration
|
Number of MDLAP-recommendations that were rejected by the physician
|
during each 6 days iteration
|
|
Number and type of changes in any pump setting per iteration
Prazo: during each 6 days iteration
|
Number and type of changes in any pump setting per iteration
|
during each 6 days iteration
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Moshe Phillip, Prof, Schenider Children's Medical
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- rmc005816ctil
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