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임상시험 NCT06311019 (Dia2tech)은(는) 인슐린으로 치료하는 제2형 당뇨병에 대해 진행중, 모집종료 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
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카드 뷰
The Effects of CGM and Connected Pen in T2DM Treated With Multiple Daily Insulin Injections (Dia2tech) 104
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임상시험 NCT06311019 (Dia2tech)은(는) 인슐린으로 치료하는 제2형 당뇨병에 대해 알아보는 중재연구입니다. 현재 상태는 진행중, 모집종료이며, 연구는 2024년 2월 27일에 시작되어 104명의 참여자를 모집하고 있습니다. Klavs Würgler Hansen이(가) 진행하며, 2025년 9월 1일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2024년 11월 7일에 갱신되었습니다.
간단한 개요
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.
상세한 설명
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...
더 보기공식 제목
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.
질환명
인슐린으로 치료하는 제2형 당뇨병기타 연구 식별자
- Dia2tech
- 791572
NCT 번호
실제 연구 시작일
2024-02-27
최신 업데이트 게시
2024-11-07
예상 연구 완료일
2025-09-01
계획된 등록 인원
104
연구종류
중재연구
단계/상
해당 없음
상태
진행중, 모집종료
키워드
Type 2 diabetes mellitus
Insulin
Continuous glucose monitoring
Connected Pen
Insulin
Continuous glucose monitoring
Connected Pen
주요 목적
치료
설계 할당
무작위배정
중재 모델
평행설계
맹검 (마스킹)
없음 (오픈 라벨)
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
비개입1 (Standard care) In this arm the patients continue to measure blood glucose with fingerprick and use standard insulin pens | 해당 없음 |
활성 대조군2 (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 |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
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 |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
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 |
참여 도우미
적격성 기준
연령대
성인, 노인
최소 연령
18 Years
참여 가능한 성별
전체
- - 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 Hospital연구 책임자
Klavs Würgler Hansen, 의뢰자-연구자, Professor, Central Jutland Regional Hospital
연락처 정보가 없습니다.
5 1개국에 임상시험 장소
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