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O estudo clínico NCT05803473 (DIATEC) para Diabetes mellitus, tipo 2 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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DIAbetes TEam and Cgm in Managing Hospitalised Patients with Diabetes (DIATEC) 166
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O estudo clínico NCT05803473 (DIATEC) foi um estudo intervencionista para Diabetes mellitus, tipo 2. Seu status atual é: concluído. O estudo começou em 11 de abril de 2023 e incluiu 166 participantes. Coordenado por Peter Kristensen e foi concluído em 29 de julho de 2024. Essas informações foram atualizadas no ClinicalTrials.gov em 26 de fevereiro de 2025.
Resumo
This trial investigates the effects of continuous glucose monitoring (CGM) and an in-hospital diabetes team on in-hospital glycemic and clinical outcomes in patients with type 2 diabetes compared to standard glucose point-of-care (POC) testing and an in-hospital diabetes team.
Descrição detalhada
In Denmark and worldwide, 15-20 % of hospitalised patients have diabetes mellitus. For most patients, diabetes is not the primary cause of admission. The patients are therefore under the care of non-diabetes specialists. Consequently, diabetes management can be inadequate resulting in hypoglycemia, hyperglycemia, and increased glycemic variability, which might increase patient mortality, morbidity, and length of hosp...Mostrar mais
Título oficial
In-hospital Diabetes Management by a Diabetes Team and Continuous Glucose Monitoring or Point of Care Glucose Testing (DIATEC): a Randomised Trial
Condições médicas
Diabetes mellitus, tipo 2Publicações
Artigos científicos e trabalhos de pesquisa publicados sobre este estudo clínico:Outros IDs do estudo
- DIATEC
- 2301240
Número NCT
Data de início (real)
2023-04-11
Última atualização postada
2025-02-26
Data de conclusão (estimada)
2024-07-29
Inscrição (estimada)
166
Tipo de estudo
Intervencionista
FASE
N/A
Status
Concluído
Palavras-chave
Inpatient
Randomised controlled trial
Hyperglycemia
Hypoglycemia
Glycemic variabiity
Continuous glucose monitoring
CGM
In-hospital
Telemetric continuous glucose monitoring
Randomised controlled trial
Hyperglycemia
Hypoglycemia
Glycemic variabiity
Continuous glucose monitoring
CGM
In-hospital
Telemetric continuous glucose monitoring
Propósito principal
Tratamento
Alocação do design
Randomizado
Modelo de intervenção
Paralelo
Cegamento (Mascaramento)
Nenhum (Aberto)
Braços / Intervenções
| Grupo de participantes/Braço | Intervenção/Tratamento |
|---|---|
Comparador ativoPOC-arm Subjects are monitored by point-of-care (POC) glucose testing. Diabetes management is done by usual ward nurses and guided by an in-hospital diabetes team. A blinded CGM is mounted in the POC-arm for outcome analysis. | FreeStyle Precision Pro Glucometer for glucose POC testing For the POC-arm subjects, glucose assessment is done by standard ward glucometer. |
ExperimentalCGM-arm CGM-arm subjects are monitored by CGM viewed by the in-hospital diabetes team in addition to POC glucose testing performed by usual ward nurses. Diabetes management is done by usual ward nurses by POC glucose testing and guided by an in-hospital diabetes team with acces to CGM data. | Dexcom G6 Continuous Glucose Monitoring System (Dexcom Inc., San Diego, USA) For CGM-arm subjects, glucose data are obtained by the CGM Dexcom G6 which via an iPhone SE 3 transmits data to the in-hospital diabetes team stations to be displayed on an iPad 9 10.2". |
Desfecho primário
Desfecho secundário
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
Time in range | Time in range (TIR) is defined as the percentage of time within glucose level of 3.9-10.0 mmol/L (70-180 mg/dL) measured by CGM. | During hospitalization (up to 30 days) |
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
Time in range per day 3.9-10.0 mmol/L (70-180 mg/dL) | Percentage of time in range assessed each day of inclusion; amount of time (hours and minutes). | During hospitalization (up to 30 days) |
Time above range (TAR) >10.0 mmol/L (>180 mg/dL) | Percentage of time above range; amount of time (hours and minutes). | During hospitalization (up to 30 days) |
Time above range (TAR) >13.9 mmol/L (>250 mg/dL) | Percentage of time above range; amount of time (hours and minutes). | During hospitalization (up to 30 days) |
Time below range (TBR) <3.9 mmol/L (<70 mg/dL) | Percentage of time below range; amount of time (hours and minutes) | During hospitalization (up to 30 days) |
Time below range (TBR) <3.0 (<54 mg/dL) | Percentage of time below range; amount of time (hours and minutes) | During hospitalization (up to 30 days) |
Standard deviation (SD) of all CGM glucose levels | mmol/L (mg/dL) | During hospitalization (up to 30 days) |
Coefficient of variation (CV) | SD divided by mean glucose level | During hospitalization (up to 30 days) |
Mean glucose levels | mmol/L (mg/dL) | During hospitalization (up to 30 days) |
Hypoglycemia < 3.9 mmol/L (< 70 mg/dL) | mmol/L (mg/dL), duration ≥15 consecutive min. | During hospitalization (up to 30 days) |
Hypoglycemia (level 1) 3.0-3.8 mmol/L (54-69 mg/dL) | mmol/L (mg/dL), duration ≥15 consecutive min. | During hospitalization (up to 30 days) |
Hypoglycemia (level 2) < 3.0 mmol/L (<54 mg/dL) | mmol/L (mg/dL), duration ≥15 consecutive min. | During hospitalization (up to 30 days) |
Recurrent hypoglycemic events | Number; Reoccurring hypoglycemic events after the first episode of hypoglycemia. | During hospitalization (up to 30 days) |
Critérios de elegibilidade
Idades elegíveis
Adulto, Idoso
Idade mínima
18 Years
Sexos elegíveis
Todos
- A documented history of T2DM prior to inclusion
- Age ≥ 18 years old
- Willingness and ability to comply with the clinical investigation plan
- Ability to communicate in Danish with the trial personnel
- An expected length of hospital stay for at least two days after enrolment
- If subject with childbearing potential (subject < 50 years old); willing to have a urine pregnancy test performed and/or to use a highly effective method of contraception (i.e., birth control implant, intrauterine device, birth control shot, or sterilisation).
- Patients on out-hospital basal insulin with duration of action > 24 hours (Toujeo or Tresiba)
- Treated with hydroxyurea/hydroxycarbamid
- Nutritional therapy (continuous enteral or parenteral feeding)
- Clinically relevant pancreatic disease
- Systemic glucocorticoid treatment with prednisone equivalent dose >5 mg/day
- Expected to require admission to the intensive-care unit
- Anasarca (severe and general edema)
- Dialysis
- Estimated glomerular filtration rate (eGFR) <15 mL/min/1.73 m2
- Known hypersensitivity to the band-aid of the CGM Dexcom G6 sensor.
Peter KristensenResponsável pelo estudo
Peter Kristensen, Patrocinador-Investigador, Medical Doctor, PhD, Clinical Associate Professor, Nordsjaellands Hospital
Sem dados de contato.
2 Locais do estudo em 1 países
Copenhagen University Hospital - Herlev-Gentofte (Steno Diabetes Center Copenhagen), Herlev, 2730, Denmark
Copenhagen University Hospital - North Zealand, Hillerød, 3400, Denmark