Impact of Dietary Intervention Within an Interprofessional Cooperative Protocol for Prandial Insulin Dose Adjustment in People Living With Type 1 Diabetes (INSUDIETCOOP)
This retrospective multicenter cohort study aims to evaluate the effectiveness of an interprofessional cooperative protocol allowing dietitians to adjust prandial insulin-to-carbohydrate ratios in adults living with type 1 diabetes receiving functional insulin therapy. Glycemic outcomes will be assessed using continuous glucose monitoring data collected during routine clinical care. The primary endpoint is the change in Time in Range (TIR) between baseline and 6 months.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Type 1 diabetes requires continuous adjustment of insulin doses according to carbohydrate intake. In France, an interprofessional cooperation protocol implemented in 2023 authorizes trained dietitians to adjust insulin-to-carbohydrate ratios under physician supervision.
This retrospective multicenter cohort study will evaluate whether this organization improves glycemic control in routine clinical practice. Data will be collected from medical records and glucose monitoring platforms without modifying patient management.
The primary outcome is the difference in Time in Range (0.70-1.80 g/L) between baseline (M0) and Month 6 (M6). Secondary outcomes include differences in hypoglycemia, hyperglycemia, glucose variability and Glucose Management Indicator (GMI) assessed between baseline and follow-up visits at Month 3 and Month 6.
Tipo di studio
Iscrizione (Stimato)
Contatti e Sedi
Contatto studio
- Nome: Youcef Sekour
- Numero di telefono: +33156095823
- Email: youcef.sekour@aphp.fr
Luoghi di studio
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Paris, Francia
- Service de diabétologie, Hôpital Lariboisière - AP-HP
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Contatto:
- Hélène Louvet
- Numero di telefono: +33149959014
- Email: hélène.louvet@aphp.fr
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Investigatore principale:
- Hélène Louvet
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Paris, Francia
- Service de nutrition - diabétologie, Hôpital Européen Georges Pompidou - AP-HP
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Contatto:
- Virginie Lafaille
- Numero di telefono: +33156095161
- Email: virginie.lafaille@aphp.fr
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Investigatore principale:
- Virginie Lafaille
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Adults aged 18-69 years with type 1 diabetes or insulin-deficient diabetes receiving routine care under an interprofessional cooperation protocol for prandial insulin dose adjustment. Eligible participants must have had diabetes for more than 6 months, be treated with multiple daily insulin injections or an insulin pump, and have completed structured education in functional insulin therapy. Patients with unstable proliferative retinopathy, pregnancy, other types of diabetes, temporary treatments affecting insulin requirements, legal protection measures, or who object to the use of their data are excluded
Descrizione
Inclusion Criteria:
- Male or female, aged 18 to 69 years.
- Receiving routine clinical care under an interprofessional cooperation protocol for prandial insulin dose adjustment (protocol implemented since January 1, 2023).
- Living with type 1 diabetes mellitus or insulin-deficient diabetes, confirmed by the presence of anti-GAD, anti-IA2, anti-ZnT8, or insulin autoantibodies, and requiring optimization of insulin therapy.
- Diabetes duration greater than 6 months.
- Treated with multiple daily insulin injections or an insulin pump (open-loop or hybrid closed-loop system).
- Completion of a structured therapeutic education program in functional insulin therapy (individual consultations and/or educational workshops).
- Able to understand study information and procedures.
Exclusion Criteria:
- Unstable severe proliferative diabetic retinopathy.
- Any type of diabetes other than type 1 diabetes or insulin-deficient diabetes.
- Pregnant women with type 1 diabetes.
- Current treatment with temporary therapies that may affect insulin requirements (e.g., chemotherapy or systemic corticosteroid therapy).
- Individuals under legal guardianship, curatorship, or any other legal protection measure.
- Objection to the use of personal data for research purposes
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: COHORT
- Prospettive temporali: RETROSPECTIVE
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
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Patients receiving routine care under a cooperation protocol for prandial insulin adjustment
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Data collection from patients receiving standard care under a cooperation protocol for prandial insulin dose adjustment, with data collected from patients' medical records and glucose monitoring platforms without modifying patient management |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Difference in Time in Range (0.70-1.80 g/L) between baseline (M0) and Month 6 (M6)
Lasso di tempo: Baseline and 6 months
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Baseline and 6 months
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Difference in time spent in the glycemic target range (Time in Range, TIR between 0.70 g/L and 1.80 g/L) between M3 and M0
Lasso di tempo: Baseline and 3 months
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Baseline and 3 months
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Difference in time spent in hypoglycemia (Time Below Range, TBR < 0.70 g/L) between M3 and M0 and between M6 and M0
Lasso di tempo: Baseline, 3 months and 6 months
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Baseline, 3 months and 6 months
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Difference in time spent in severe hypoglycemia (Time Below Range, TBR < 0.54 g/L) between M3 and M0 and between M6 and M0
Lasso di tempo: Baseline, 3 months and 6 months
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Baseline, 3 months and 6 months
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Difference in time spent in hyperglycemia (Time Above Range, TAR > 1.80 g/L) between M3 and M0 and between M6 and M0
Lasso di tempo: Baseline, 3 months and 6 months
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Baseline, 3 months and 6 months
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Difference in time spent in severe hyperglycemia (Time Above Range, TAR > 2.50 g/L) between M3 and M0 and between M6 and M0
Lasso di tempo: Baseline, 3 months and 6 months
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Baseline, 3 months and 6 months
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Difference in glucose variability coefficient between M3 and M0 and between M6 and M0
Lasso di tempo: Baseline, 3 months and 6 months
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Baseline, 3 months and 6 months
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Difference in Glucose Management Indicator (GMI) between M3 and M0 and between M6 and M0
Lasso di tempo: Baseline, 3 months and 6 months
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Baseline, 3 months and 6 months
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Collaboratori e investigatori
Collaboratori
Investigatori
- Investigatore principale: Virginie Lafaille, Service de nutrition - diabétologie, Hôpital Européen Georges Pompidou - AP-HP
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- APHP260780
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
Periodo di condivisione IPD
Two years after the last publication
Criteri di accesso alla condivisione IPD
Data sharing must be accepted by the sponsor and the PI based on a scientific project and scientific involvement of the PI team. Collaboration will be fostered. The founder could be involved in the decision. Teams wishing obtain IPD must meet the sponsor and IP team to present scientifics (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractualization. Processing of shared data must comply with European General Data Protection Regulation (GDPR).
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- ICF
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
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