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임상시험 NCT04809311은(는) 제2형 당뇨병에 대해 완료 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
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노보 노디스크Remote Study Collecting Blood Glucose Values and Activity Data in Patients With Type 2 Diabetes on Different Treatments 156 원격 참여 비대면
임상시험 세부 정보는 주로 영어로 제공됩니다. 하지만 임상 레이더 AI가 도와드릴 수 있습니다! '임상시험 설명'를 클릭하여 선택한 언어로 임상시험 정보를 확인하고, 이에 대해 AI와 논의해 보세요.
임상시험 NCT04809311은(는) 제2형 당뇨병에 대해 알아본 관찰연구입니다. 현재 상태는 완료입니다. 연구는 2024년 4월 30일에 시작되어 156명의 참여자와 함께 진행되었습니다. 노보 노디스크이(가) 진행한 이 연구는 2025년 1월 7일에 마무리되었습니다. ClinicalTrials.gov의 가장 최근 정보는 2025년 3월 21일에 갱신되었습니다.
간단한 개요
Earlier protocol ID was NN1250-4630, protocol ID is changed to NN1535-7774. The purpose of this study is to collect blood glucose values and activity data in patients with type 2 diabetes for approximately 12 weeks using electronic devices in a full virtual clinical setting. Virtual clinical setting means that all data are collected by use of participants' personal smartphone and study-related apps. In other words, e...더 보기
공식 제목
Fully Decentralised Clinical Study Exploring Remote Collection of Glycaemic and Behaviometric Data Among Participants With Type 2 Diabetes Mellitus on Different Treatment Regimens
질환명
제2형 당뇨병기타 연구 식별자
- NN1535-7774
- U1111-1254-5030 (기타 식별자) (World Health Organization (WHO))
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
Other oral antidiabetic drugs (OADs) ± metformin Patients will continue their antidiabetic treatment as per usual clinical practice at the discretion of their own treating physician | Oral antidiabetetic drugs During the study, no medical drugs will be supplied to the patients. Patients will continue their antidiabetic treatment independently of this study and at the treating physician's discretion as part of usual clinical practice.
Approximately 12-week study duration |
Basal insulin ± OADs Patients will continue their antidiabetic treatment as per usual clinical practice at the discretion of their own treating physician | Basal insulin During the study, no medical drugs will be supplied to the patients. Patients will continue their antidiabetic treatment independently of this study and at the treating physician's discretion as part of usual clinical practice.
Approximately 12-week study duration |
Glucagon-like peptide-1 (GLP-1) ± Basal insulin (loose and fixed combination) ± OADs Patients will continue their antidiabetic treatment as per usual clinical practice at the discretion of their own treating physician | Basal insulin During the study, no medical drugs will be supplied to the patients. Patients will continue their antidiabetic treatment independently of this study and at the treating physician's discretion as part of usual clinical practice.
Approximately 12-week study duration Glucagon-like peptide-1 (GLP-1) During the study, no medical drugs will be supplied to the patients. Patients will continue their antidiabetic treatment independently of this study and at the treating physician's discretion as part of usual clinical practice.
Approximately 12-week study duration |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Participant invited to consent and consented via e-signature (Yes/No) | Measured as count of participants. | During Screening (Week -2 to week 0 ) |
Participant with at least 70% unblinded CGM (continuous glucose monitoring) data (Yes/No) | Measured as Count of participants. | From time of first unblinded CGM measurement until 10 weeks after the time of first unblinded CGM measurement |
Participant completion of questionnaires and per protocol planned remote visits (RVs) | % of questionnaires and RVs completed. | From week 0 until end of study (week 12) |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Time in range (TIR) (3.9-10 mmol/L) | % of time. | From time of first unblinded CGM measurement (week 2) until time of last unblinded CGM measurement (week 12) |
Time above range (TAR) (above 10 mmol/L) | % of time. | From time of first unblinded CGM measurement (week 2) until time of last unblinded CGM measurement (week 12) |
Time below range (TBR) L1 (3.0-3.9 mmol/L) | % of time. | From time of first unblinded CGM measurement (week 2) until time of last unblinded CGM measurement (week 12) |
Time below range (TBR) L2 (below 3.0 mmol/L) | % of time. | From time of first unblinded CGM measurement (week 2) until time of last unblinded CGM measurement (week 12) |
Mean glucose | nmol/L. | From time of first unblinded CGM measurement (week 2) until time of last unblinded CGM measurement (week 12) |
Coefficient of variation (CV) of glucose measurements | From time of first unblinded CGM measurement (week 2) until time of last unblinded CGM measurement (week 12) | |
Participant with at least 70% heart rate (pulse) data (Yes/No) | Count of participants. | From time of first heart rate measurement (week 0) until 12 weeks after the time of first heart rate measurement |
적격성 기준
연령대
성인, 노인
최소 연령
18 Years
참여 가능한 성별
전체
Willingness to consent via the e-consent process before any study-related activities takes place (study-related activities are any procedure related to recording of data according to the protocol)
Male or female, age above or equal to 18 years at the time of signing informed consent
Diagnosed T2DM for more than 3 months prior to signing the informed consent
On one of the following treatments for T2DM:
- Metformin ± other OADs
- Basal insulin ± OADs
- GLP-1 ± Basal insulin (loose and fixed combination) ± OADs
Willingness to, and capable of applying and using the study devices
Willingness to follow study procedures
Fluent in Danish both oral, reading and in writing
In possession of a compatible smartphone throughout the study, meaning that the smartphone fulfils the criteria to the operating system for using the devices needed for the study
- Previous participation in this study. Participation is defined as having given informed consent in this study
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
- Participation in any other study investigating diabetes.
- Patients who do not have a blood glucose meter at home
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