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O estudo clínico NCT06311019 (Dia2tech) para Diabetes tipo 2 tratado com insulina está ativo, não recrutando. 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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The Effects of CGM and Connected Pen in T2DM Treated With Multiple Daily Insulin Injections (Dia2tech) 104
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 NCT06311019 (Dia2tech) é um estudo intervencionista para Diabetes tipo 2 tratado com insulina. Seu status atual é: ativo, não recrutando. O estudo começou em 27 de fevereiro de 2024 e pretende incluir 104 participantes. Coordenado por Klavs Würgler Hansen e deve ser concluído em 1 de setembro de 2025. Essas informações foram atualizadas no ClinicalTrials.gov em 7 de novembro de 2024.
Resumo
The aim of the study is to evaluate the effect of a combination of 12 months treatment with CGM (Freestyle Libre 2) with hypo and hyper alert in combination with a smart pen for bolus insulin (NOVOpen6) on HbA1c and time in range (TIR) in T2DM patients with baseline HbA1c >53 mmol/mol (7. 0%, eAG 8,6 mmol/l) as compared with standard care.
Descrição detalhada
This study is a 12 months open-label randomized controlled trial.
Subjects with basal/bolus insulin treated T2DM and HbA1c >53 mmol/mol are randomized to:
A (control): standard care with disposable insulin pens and fingerprick glucose measurement or B (intervention): Novopen6 for bolus insulin and glucose measurement with Freestyle Libre 2.
Due to the nature of the treatments it is not possible to perform a blind...
Mostrar maisTítulo oficial
The Effects of Continuous Glucose Monitoring and Connected Insulin Pens on Glycemic Control in Patients With Type 2 Diabetes Treated With Multiple Daily Insulin Injections.
Condições médicas
Diabetes tipo 2 tratado com insulinaOutros IDs do estudo
- Dia2tech
- 791572
Número NCT
Data de início (real)
2024-02-27
Última atualização postada
2024-11-07
Data de conclusão (estimada)
2025-09-01
Inscrição (estimada)
104
Tipo de estudo
Intervencionista
FASE
N/A
Status
Ativo, não recrutando
Palavras-chave
Type 2 diabetes mellitus
Insulin
Continuous glucose monitoring
Connected Pen
Insulin
Continuous glucose monitoring
Connected Pen
Propósito principal
Tratamento
Alocação do design
Randomizado
Modelo de intervenção
Paralelo
Cegamento (Mascaramento)
Nenhum (Aberto)
Braços / Intervenções
| Grupo de participantes/Braço | Intervenção/Tratamento |
|---|---|
Nenhuma intervenção1 (Standard care) In this arm the patients continue to measure blood glucose with fingerprick and use standard insulin pens | N/A |
Comparador ativo2 (CGM and connected pen) In this arm the patients switch from glucose measurement with fingerprick to continuous glucose monitoring and they switch from standard insulin pen for bolusinsulin to connected pen for bolusinsulin | Continuous glucose monitoring and use of connected insulinpen for bolus insulin Continuous glucose monitoring (Abbott Freestyle Libre 2) and use of connected insulinpen (Novopen 6) for bolus insulin |
Desfecho primário
Desfecho secundário
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
Change in Haemoglobin A1c | Change between groups in Haemoglobin A1c (mmol/mol) from baseline to follow-up
A prespecified exploratory analysis is planned for:
male vs. female age \< 65 year vs. age ≥ 65 year baseline HbA1c \< 58 mmol/l vs baseline HbA1c ≥58 mmol/l Bolus insulin for 1 or 2 meals at baseline vs. bolus insulin for \> 2 meals Number of average views by Libre 2 for the last month \< 10 vs. per day vs. ≥10 scannings.
A per-protocol analysis will be performed for patients in the intervention arm with available glucose values for more than 70 % of the time during the last 30 days. | Baseline and follow-up after 12 months |
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
Change Time in range | Change in the fraction (%) of glucose values in the range 3.9 to 10.0 mmol/l, measured by Libre Pro IQ for 14 days.
A prespecified exploratory analysis is planned for:
male vs. female age \< 65 year vs. age ≥ 65 year baseline HbA1c \< 58 mmol/l vs baseline HbA1c ≥58 mmol/l Bolus insulin for 1 or 2 meals at baseline vs. bolus insulin for \> 2 meals Number of average views by Libre 2 for the last month \< 10 vs. per day vs. ≥10 scannings.
A per-protocol analysis will be performed for patients in the intervention arm with available glucose values for more than 70 % of the time during the last 30 days. | Baseline and follow-up after 12 months |
Change in Time above range | Change in The fraction (%) of glucose values in the range \> 10.0 mmol/l, measured by Libre Pro IQ for 14 days.
A prespecified exploratory analysis is planned for:
male vs. female age \< 65 year vs. age ≥ 65 year baseline HbA1c \< 58 mmol/l vs baseline HbA1c ≥58 mmol/l Bolus insulin for 1 or 2 meals at baseline vs. bolus insulin for \> 2 meals Number of average views by Libre 2 for the last month \< 10 vs. per day vs. ≥10 scannings.
A per-protocol analysis will be performed for patients in the intervention arm with available glucose values for more than 70 % of the time during the last 30 days. | Baseline and follow-up after 12 months |
Change in Time below range | Change in the fraction (%) of glucose values \< 3.9 mmol/l, measured by Libre Pro IQ for 14 days.
A prespecified exploratory analysis is planned for:
male vs. female age \< 65 year vs. age ≥ 65 year baseline HbA1c \< 58 mmol/l vs baseline HbA1c ≥58 mmol/l Bolus insulin for 1 or 2 meals at baseline vs. bolus insulin for \> 2 meals Number of average views by Libre 2 for the last month \< 10 vs. per day vs. ≥10 scannings.
A per-protocol analysis will be performed for patients in the intervention arm with available glucose values for more than 70 % of the time during the last 30 days. | Baseline and follow-up after 12 months |
Mean glucose | The mean of all glucose values for 14 days measured by Libre Pro IQ.
A prespecified exploratory analysis is planned for:
male vs. female age \< 65 year vs. age ≥ 65 year baseline HbA1c \< 58 mmol/l vs baseline HbA1c ≥58 mmol/l Bolus insulin for 1 or 2 meals at baseline vs. bolus insulin for \> 2 meals Number of average views by Libre 2 for the last month \< 10 vs. per day vs. ≥10 scannings.
A per-protocol analysis will be performed for patients in the intervention arm with available glucose values for more than 70 % of the time during the last 30 days. | Baseline and follow-up after 12 months |
Standard deviation | The standard deviation of glucose values for 14 days, measured by Libre Pro IQ.
A prespecified exploratory analysis is planned for:
male vs. female age \< 65 year vs. age ≥ 65 year baseline HbA1c \< 58 mmol/l vs baseline HbA1c ≥58 mmol/l Bolus insulin for 1 or 2 meals at baseline vs. bolus insulin for \> 2 meals Number of average views by Libre 2 for the last month \< 10 vs. per day vs. ≥10 scannings.
A per-protocol analysis will be performed for patients in the intervention arm with available glucose values for more than 70 % of the time during the last 30 days. | Baseline and follow-up after 12 months |
Change in CV | Change in the coefficient of variation (%) for glucose values for 14 days, measured by Libre Pro IQ for 14 days.
A prespecified exploratory analysis is planned for:
male vs. female age \< 65 year vs. age ≥ 65 year baseline HbA1c \< 58 mmol/l vs baseline HbA1c ≥58 mmol/l Bolus insulin for 1 or 2 meals at baseline vs. bolus insulin for \> 2 meals Number of average views by Libre 2 for the last month \< 10 vs. per day vs. ≥10 scannings.
A per-protocol analysis will be performed for patients in the intervention arm with available glucose values for more than 70 % of the time during the last 30 days. | Baseline and follow-up after 12 months |
Change in Time with rapid glucose change | Change in the time fraction (%) with glucose rate of change \> 1.5 mmol/l/15 min, measured by Libre Pro. A prespecified exploratory analysis is planned for:
male vs. female age \< 65 year vs. age ≥ 65 year baseline HbA1c \< 58 mmol/l vs baseline HbA1c ≥58 mmol/l Bolus insulin for 1 or 2 meals at baseline vs. bolus insulin for \> 2 meals Number of average views by Libre 2 for the last month \< 10 vs. per day vs. ≥10 scannings.
A per-protocol analysis will be performed for patients in the intervention arm with available glucose values for more than 70 % of the time during the last 30 days.
IQ for 14 days. | Baseline and follow-up after 12 months |
Change in ARRC | Change in Mean of average absolute change of glucose rate (ml/mol/15 min), measured by Libre Pro IQ for 14 days. A prespecified exploratory analysis is planned for:
male vs. female age \< 65 year vs. age ≥ 65 year baseline HbA1c \< 58 mmol/l vs baseline HbA1c ≥58 mmol/l Bolus insulin for 1 or 2 meals at baseline vs. bolus insulin for \> 2 meals Number of average views by Libre 2 for the last month \< 10 vs. per day vs. ≥10 scannings.
A per-protocol analysis will be performed for patients in the intervention arm with available glucose values for more than 70 % of the time during the last 30 days. | Baseline and follow-up after 12 months |
Fraction of patients with increased number of bolus insulin per day | The fraction of patients increasing from one or two meals with bolus insulin to two or three meals with bolus insulin. | Baseline and follow-up after 12 months |
Assistente de participação
Critérios de elegibilidade
Idades elegíveis
Adulto, Idoso
Idade mínima
18 Years
Sexos elegíveis
Todos
- - Type 2 DM.
- - HbA1c > 53 mmol/l (7.0 %, estimated average glucose (eAG) 8.6 mmol/l).
- - Contact to diabetes clinic for ≥ 6 months.
- - Insulin treatment ≥ 12 months.
- - Basal insulin and bolus insulin at least for one meal every day.
- - Bolus insulin is insulin aspart.
- - Stable insulin treatment (change 10 % or less) and no introduction of other antihyperglycemic agents (oral or GLP1 analogue) for at least 2 months before randomization.
- - Considered to be technically and intellectually capable of using isCGM and smart pen.
- - Can communicate in Danish.
- - Informed consent including acceptance to share glucose data from the Libreview platforms.
- - The patient has a smart phone suitable for Libre and NOVOpen6 data registration.
- - Individual goal for HbA1c is reached (even if > 53 mmol/mol), i.e. relaxed treatment goals as relevant for fragile patients with severe diabetic complications or comorbidities.
- - Fasting C-peptide < 370 pmol/l.
- - Actual treatment with CGM or previous use of CGM for more than four weeks or < 6 months before recruitment. No actual or previous use of connected pen.
- - One or more severe hypoglycemic episode (assistance of third party) within the previous 12 months.
- - Considered unable to participate due to frequent cancellation of appointments.
- - Ongoing steroid treatment or expected intermittent treatment of more than 14 days' duration.
- - Pregnant or planning pregnancy.
- - Participating in other trials.
- - Clinical conditions interfering with interpretation of HbA1c (phlebectomy, bleeding or haemolytic disorders, erythropoietin treatment, known haemoglobin variants, etc.) or continuous intake of high dose of vitamin C (> 1000 mg), salicylic acid (650 mg daily), Salazopyrin or Dapsone.
- - Allergic reaction to the adhesive used in the isCGM.
Klavs Würgler HansenAarhus University HospitalResponsável pelo estudo
Klavs Würgler Hansen, Patrocinador-Investigador, Professor, Central Jutland Regional Hospital
Sem dados de contato.
5 Locais do estudo em 1 países
Steno Diabetes Center Aarhus, Aarhus, 8000, Denmark
Gødstrup Regional Hospital, Herning, 7400, Denmark
Horsens Regional Hospital, Horsens, 8700, Denmark
Randers Regional Hospital, Randers, 8900, Denmark
Regional Hospital Silkeborg, Central Jutland Hospital, Silkeborg, 8600, Denmark