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O estudo clínico NCT06645834 para Diabetes mellitus tipo 1 está concluído. Consulte a visualização em cartões do Radar de Estudos Clínicos e as ferramentas de descoberta de IA para ver todos os detalhes. Ou pergunte qualquer coisa aqui. | ||
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Smart MDI Study (CIP343) 179
Os detalhes do estudo clínico estão disponíveis principalmente em inglês. No entanto, a IA Trial Radar pode ajudar! Basta clicar em 'Explicar o estudo' para visualizar e discutir as informações do estudo no idioma selecionado.
O estudo clínico NCT06645834 foi um estudo intervencionista para Diabetes mellitus tipo 1. Seu status atual é: concluído. O estudo começou em 6 de dezembro de 2024 e incluiu 179 participantes. Coordenado por Medtronic Diabetes e foi concluído em 1 de dezembro de 2025. Essas informações foram atualizadas no ClinicalTrials.gov em 9 de dezembro de 2025.
Resumo
The purpose of the study is to evaluate the effectiveness of the Smart MDI system with InPen™ and Simplera™ in comparison with Multiple Daily Injection (MDI) therapy with intermittent scanning or real-time Continuous Glucose Monitoring (isCGM/CGM) over 6 months duration in people with type 1 diabetes to support the market access and therapy adoption of the Smart MDI system.
Descrição detalhada
This is a post-market, prospective, open-label, multi-center, randomized controlled trial in adult and pediatric subjects with type 1 diabetes.
The study consists of a run-in phase of 3 weeks and a study phase of 6 months.
The purpose of the run-in phase is to collect baseline HbA1c and CGM data while subjects are on their current therapy.
During the 6-month study phase, subjects will be randomized to continue wit...
Mostrar maisTítulo oficial
Smart MDI Randomized Controlled Trial in Subjects With Type 1 Diabetes (Smart MDI Study)
Condições médicas
Diabetes mellitus tipo 1Outros IDs do estudo
- CIP343
Número NCT
Data de início (real)
2024-12-06
Última atualização postada
2025-12-09
Data de conclusão (estimada)
2025-12-01
Inscrição (estimada)
179
Tipo de estudo
Intervencionista
FASE
N/A
Status
Concluído
Propósito principal
Tratamento
Alocação do design
Randomizado
Modelo de intervenção
Paralelo
Cegamento (Mascaramento)
Nenhum (Aberto)
Braços / Intervenções
| Grupo de participantes/Braço | Intervenção/Tratamento |
|---|---|
OutroTreatment Subjects will start using the Smart MDI system consisting of the InPen™ System and Simplera™ System. | Smart MDI System The Smart MDI system consists of the InPen™ system and Simplera™ system.
The InPen™ system includes a reusable smart bolus insulin pen injector with Bluetooth combined with the InPen™ app to help users take insulin doses.
And InPen™ app which communicates with the InPen™ injector and compatible continuous glucose monitoring (CGM) devices to collect and display information on insulin delivered by the injector as wel...Mostrar mais |
Nenhuma intervençãoControl None -Subjects will continue their own MDI therapy | N/A |
Desfecho primário
Desfecho secundário
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
Primary Endpoint | The primary endpoint is the between-treatment (Smart MDI system arm vs MDI + isCGM or CGM arm) difference during the study phase in the percentage of time that the sensor glucose measurement is in the target range, 70 to 180 mg/dL (3.9-10.0 mmol/L). The endpoint will be assessed for non-inferiority with an absolute margin of 7.5% time in target range. | 6-month study period |
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
Secondary Endpoint 1 | Mean HbA1c at the end of the 6-month study phase, non-inferiority test with an absolute margin of 0.4% HbA1c. | 6-month study period |
Secondary Endpoint 2 | % of Time spent in target range (70 to 180 mg/dL \[3.9-10.0 mmol/L\]) during the study phase, simple superiority test. | 6-month study period |
Secondary Endpoint 3 | Mean HbA1c at the end of the 6-month study phase, simple superiority test. | 6-month study period |
Critérios de elegibilidade
Idades elegíveis
Criança, Adulto, Idoso
Idade mínima
2 Years
Sexos elegíveis
Todos
- Subject is age 2 years or older at time of screening.
- Subject is on MDI therapy (defined as ≥ 3 insulin injections per day and on a basal/bolus regimen) ≥ 6 months prior to screening.
- Subject has a clinical diagnosis of type 1 diabetes for ≥ 12 months.
- Subject is on MDI therapy with intermittent scanning or Continuous Glucose Monitoring (isCGM/CGM) ≥ 3 months prior to screening.
- Subject has high compliance with sensor wear, per investigator assessment.
- Subject has a Glycosylated hemoglobin (HbA1c) ≥ 8% (64 mmol/mol) as assessed locally at time of screening visit.
- Subject is willing to take or switch to one of the InPen-compatible insulin types, NovoRapid™, Fiasp™, Humalog™ and Lyumjev™.
- Subject or parent(s)/legal guardian(s) has a compatible mobile phone with Internet access.
- Subject or parent(s)/legal guardian(s) is willing and able to provide written informed consent, comply with all study procedures and wear all study devices, as required during the study.
- Subject is using a Medtronic InPen™ for at least 3 months prior to screening.
- Subject has untreated/unstable Addison's disease, growth hormone deficiency, hypopituitarism or definite gastroparesis, untreated coeliac disease, untreated thyroid disorder, or poorly controlled asthma, per investigator judgment.
- Subject is planning to initiate or change to another glucose modifying therapy (for example pramlintide, DPP-4 inhibitor, GLP-1 agonists/mimetics, metformin or SGLT2 inhibitors).
- Subject has taken any oral, injectable, or intravenous (IV) glucocorticoids within 8 weeks from time of screening visit, or plans to take any oral, injectable, or IV glucocorticoids during the course of the study chronically.
- Subject has renal failure (stage 4 and above) defined by creatinine clearance of <30 ml/min, as assessed by Local Lab test ≤ 6 months before screening or performed at screening at Local Lab, as defined by the creatinine-based Cockcroft, CKD-EPI or MDRD equations.
- Subject has any unresolved adverse skin conditions in the area of sensor placement (e.g. psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection).
- Subject is actively participating in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or device in the last 2 weeks before enrollment into this study, as per investigator judgment.
- Subject is currently abusing illicit drugs, marijuana, alcohol or prescription drugs (other than nicotine), per investigator judgment.
- Subject has any other disease or condition that may preclude the patient from participating in the study, per investigator judgment.
- Subject is a woman of child-bearing potential who has a positive pregnancy test at screening or plans to become pregnant during the course of the study.
- Subject is a woman who is breastfeeding.
- Subject or parent(s)/legal guardian(s) is legally incompetent, illiterate or a vulnerable person.
- Subject is a member of the research staff involved with executing the study.
Medtronic DiabetesSem dados de contato.
18 Locais do estudo em 6 países
Antwerp University Hospital, Antwerp, Belgium
Hospital Universitaire Bruxelles Erasme, Brussels, Belgium
UZ Leuven, Leuven, Belgium
CHU Liege, Liège, Belgium
General University Hospital, Prague, Czechia
IKEM, Prague, Czechia
CHRU de Brest service diabetologie endocrinologie, Brest, France
Center for DIABeCare, Hospices Civils de Lyon, Lyon, France
CHU Nimes, Nîmes, France
Hospital Rangueil, Toulouse, France
Zentrum fur digitale Diabetologie Hamburg, Hamburg, Germany
Hannoversche Kinderheilanstalt, Hanover, Germany
MVZ Stoffwechselmedizin Leipzig, Leipzig, Germany
University of Bari Aldo Moro, Bari, Italy
ASST Spedali Civili Brescia, Brescia, Italy
Sahlgrenska University Hospital, Gothenburg, Sweden
Uddevalla Hospital, Uddevalla, Sweden
Hogsbo Narsjukhus, Västra Frölunda, Sweden