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.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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.
연구 유형
연구 유형
등록 (추정된)
등록
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Youcef Sekour
- 전화번호: +33156095823
- 이메일: youcef.sekour@aphp.fr
연구 장소
-
-
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Paris, 프랑스
- Service de diabétologie, Hôpital Lariboisière - AP-HP
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연락하다:
- Hélène Louvet
- 전화번호: +33149959014
- 이메일: hélène.louvet@aphp.fr
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수석 연구원:
- Hélène Louvet
-
Paris, 프랑스
- Service de nutrition - diabétologie, Hôpital Européen Georges Pompidou - AP-HP
-
연락하다:
- Virginie Lafaille
- 전화번호: +33156095161
- 이메일: virginie.lafaille@aphp.fr
-
수석 연구원:
- Virginie Lafaille
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
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
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: COHORT
- 시간 관점: RETROSPECTIVE
그룹/코호트 수
코호트 및 개입
그룹/코호트그룹/코호트 |
개입 / 치료개입 / 치료 |
|---|---|
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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 |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Difference in Time in Range (0.70-1.80 g/L) between baseline (M0) and Month 6 (M6)
기간: Baseline and 6 months
|
Baseline and 6 months
|
2차 결과 측정
2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
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
기간: Baseline and 3 months
|
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
기간: 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
기간: Baseline, 3 months and 6 months
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Baseline, 3 months and 6 months
|
|
Difference in time spent in hyperglycemia (Time Above Range, TAR > 1.80 g/L) between M3 and M0 and between M6 and M0
기간: Baseline, 3 months and 6 months
|
Baseline, 3 months and 6 months
|
|
Difference in time spent in severe hyperglycemia (Time Above Range, TAR > 2.50 g/L) between M3 and M0 and between M6 and M0
기간: Baseline, 3 months and 6 months
|
Baseline, 3 months and 6 months
|
|
Difference in glucose variability coefficient between M3 and M0 and between M6 and M0
기간: Baseline, 3 months and 6 months
|
Baseline, 3 months and 6 months
|
|
Difference in Glucose Management Indicator (GMI) between M3 and M0 and between M6 and M0
기간: Baseline, 3 months and 6 months
|
Baseline, 3 months and 6 months
|
공동 작업자 및 조사자
수사관
수사관
- 수석 연구원: Virginie Lafaille, Service de nutrition - diabétologie, Hôpital Européen Georges Pompidou - AP-HP
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- APHP260780
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
IPD 공유 기간
Two years after the last publication
IPD 공유 액세스 기준
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).
IPD 공유 지원 정보 유형
- 연구_프로토콜
- ICF
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .