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O estudo clínico NCT02734667 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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Initiation of Continuous Glucose Monitoring at Diagnosis of Type 1 Diabetes 120
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O estudo clínico NCT02734667 foi um estudo intervencionista para Diabetes mellitus tipo 1. Seu status atual é: concluído. O estudo começou em 1 de fevereiro de 2016 e incluiu 120 participantes. Coordenado por Korey Hood e foi concluído em 1 de fevereiro de 2020. Essas informações foram atualizadas no ClinicalTrials.gov em 2 de março de 2022.
Resumo
The purpose of this study is to learn about the impact of continuous glucose monitoring (CGM) on families with newly diagnosed children with type 1 diabetes (T1D). The investigators hope to learn about how continuous glucose monitoring affects glycemic variables and diabetes-related distress.
Descrição detalhada
Synopsis of study protocol
This pilot randomized clinical trial compares newly diagnosed T1D youth who are started on CGM (the intervention group) versus those who are not (the control group). The investigators will examine group differences over a 6-month period (Phase 1) on two sets of outcomes: psychosocial variables and glycemic variables. After the initial comparison of intervention to control across the first ...
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Initiation of Continuous Glucose Monitoring at Diagnosis of Type 1 Diabetes
Condições médicas
Diabetes mellitus tipo 1Outros IDs do estudo
- 35990
Número NCT
Data de início (real)
2016-02
Última atualização postada
2022-03-02
Data de conclusão (estimada)
2020-02
Inscrição (estimada)
120
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 |
|---|---|
ExperimentalCGM at diagnosis of T1D Participants start non-adjunctive use of CGM at diagnosis of T1D and continue for 6 months. | CGM at diagnosis of T1D Initiation of non-adjunctive CGM use at diagnosis of T1D |
Nenhuma intervençãoUsual Care Participants receive usual care for T1D for 6 months post diagnosis. | N/A |
Desfecho primário
Desfecho secundário
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
Time Spent in Blood Glucose Range (70-180mg/dL) | Increasingly it is recognized that the percent time spent in a target blood glucose range, which is set by the American Diabetes Association, is an important outcome. This measure will be used as a primary outcome and derived from objective data downloads. It is calculated using the values for 14 days around the assessment time point. | Collected entire period for 6 months post-baseline; primary endpoint is 14 day period around that 6-month time point |
Glucose Monitoring Satisfaction Survey (GMSS) - Parent | The GMSS is a validated survey created to measure the level of satisfaction a person with diabetes - type 1 or type 2 - experiences in response to monitoring glucose values. It was validated in people using CGM. Scores range 0 to 5 with higher scores indicating greater satisfaction. | Baseline, 24 months |
Time Spent in Hypoglycemia (< 70 mg/dL) | Time spent in hypoglycemia is calculated using the values for 14 days around the assessment time point. | Collected entire period for 6 months post-baseline; primary endpoint is 14 day period around that 6-month time point |
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
Pediatric Quality of Life Inventory | This is a measure of health-related quality of life. It is used to understand the broader impact on quality of life which includes social, psychological, and health aspects of daily living. Scores range from 0 to 100. Higher scores indicate greater quality of life. | Baseline, 24 months |
Problem Areas in Diabetes Score | Participants in the study report on daily problems with diabetes via this measure. Respondents indicate the degree to which each of the items is currently a problem for them. Score range: 0 to 4, higher scores correspond to more serious problems. | Baseline, 24 months |
Diabetes Distress Scale | This measure is widely used to capture the psychological distress experienced in relation to diabetes. Parent scale score range: 0-4. Youth scale score range: 1-6. Higher scores indicate greater diabetes-related distress. | Baseline, 24 months |
Patient Health Questionnaire 9 | This is a widely used measure that captures depressive symptoms, and was used to assess health symptoms in parents. Score range: 0-24. Higher scores indicate greater severity of symptoms. | Baseline, 24 months |
State-Trait Anxiety Inventory | This is a widely used measure of anxiety symptoms, and was used to assess anxiety symptoms in parents. Score range for both state-anxiety is: 20-80. Higher scores indicate greater anxiety. | Baseline, 24 months |
Pittsburgh Sleep Quality Index | This questionnaire measures the degree to which sleep is disrupted and the quality of sleep experienced by participants, and was used to assess sleep quality in parents. Score range is: 0-21. Higher scores indicate lower sleep quality. | Baseline, 24 months |
Hypoglycemic Fear Survey | People with diabetes worry about hypoglycemia, and was used to assess parent's worry about their child. This measure captures those worries. Score range: 0-72. Higher scores indicate greater fear and worry of hypoglycemia. | Baseline, 24 months |
Hypoglycemic Confidence Questionnaire | Hypoglycemia needs to be managed in various daily situations. This questionnaire captures confidence of the participants in those various situations, and was used to assess parent's confidence. Score range: 8-32. Higher scores indicate greater confidence to manage hypoglycemia. | Baseline, 24 months |
General and Diabetes-specific Technology Use | This measure has questions on attitudes and use of various general technologies (e.g., smartphone) and diabetes devices. Score range: 5-25. Higher scores indicate more positive attitudes about technology. | Baseline, 24 months |
Center for Epidemiologic Studies Depression Measure | This is a widely used measure of depression, and was used to assess depression symptoms in youths. Score range: 0-60. Higher scores indicate greater symptoms. | Baseline, 24 months |
Child Health Utility 9D | Widely used measure of quality of life that is used to generate quality-adjusted life years, and was used to assess health symptoms in youth. Each score scale is 0 to 4, with scores of 3 or 4 denoting more severe problems. The count of participants responding 3 or higher for each parameter are presented. | Baseline, 24 months |
Hemoglobin A1c | The hemoglobin A1c value is a biologic measure of the glycemia that is the gold standard measure of "control" of diabetes. Collected through a blood sample. | Baseline, 24 months |
C-peptide | This is a biologic measure of endogenous production and is collected through a blood sample. | Baseline, 24 months |
Critérios de elegibilidade
Idades elegíveis
Criança
Idade mínima
2 Years
Sexos elegíveis
Todos
To be eligible for the study, a child must meet the following criteria:
- Diagnosis of type 1 diabetes according to American Diabetes Association diagnostic criteria
- Time since diagnosis of no longer than one month
- Age between 2 and 17 years
- Parental consent (and assent from the child where applicable) to participate in the study
- No severe medical conditions, which in the opinion of the investigators are likely to hinder participation in this clinical trial.
To be eligible for the study, a parent must meet the following criteria:
- Parent or legal guardian of a child with type 1 diabetes meeting the "child" criteria outlined above
- Age of 18.0 years or older
- Parent comprehends written English
- Parent understands the study protocol and signs the informed consent document
The presence of any of the following is an exclusion for the study:
- Child has a medical disorder that in the judgment of the investigator will interfere with completion of any aspect of the protocol (e.g., pregnancy, kidney disease, adrenal insufficiency, skin condition that may hinder sensor application).
- Child has a neurologic disorder that in the judgment of the investigator will affect completion of the protocol
- Current use of oral glucocorticoids or other medications, which in the judgment of the investigator would be a contraindication to participation in the study
- Child is unable to completely avoid acetaminophen for duration of study
Korey HoodUniversidade do Colorado em Denver480 estudos clínicos ativos para explorarResponsável pelo estudo
Korey Hood, Patrocinador-Investigador, Clinical Professor, Stanford University
Sem dados de contato.
2 Locais do estudo em 1 países
California
Stanford University, Stanford, California, 94305, United States
Colorado
University of Colorado, Aurora, Colorado, 80045, United States