Evaluation of a Treatment and Education Program for Diabetic Patients Who Use Flash Glucose Monitoring (FLASH)
Evaluation of a Newly Developed Psychoeducational Treatment and Education Program for People With Type 1 and Type 2 Diabetes on an Intensified Insulin Therapy Who Use Flash Glucose Monitoring
연구 개요
상태
정황
상세 설명
The investigators developed a new psychoeducational treatment and education program - called FLASH - for diabetic patients on an intensive insulin therapy who use flash glucose monitoring (FGM).
FLASH is a self-management-based treatment and education program. It is designed to empower patients to adequately use FGM in daily life and to train patients how to analyze their glucose data. FLASH consists of four lessons (90 minutes each).
FLASH is tested in a randomized controlled trial (RCT) with a waiting-list control group since no certified and effective treatment and education program for FGM exists.
This study is a multi-center study. Study centers are specialized diabetes practices throughout Germany. Patients will be approached by their respective practice and informed about the study. Study measurements as well as the conduct of FLASH will take place at the respective practice.
Baseline measurement will take place prior to the beginning of FLASH. After completion of baseline measurement, all patients from one study center will be randomized centrally by the Research Institute of the Diabetes Academy Mergentheim (FIDAM). 2 weeks and 6 months after the completion of FLASH, follow-up measurements will be conducted at the respective study center.
HbA1c as a marker of glycemic control will be analyzed in a central laboratory. Time-in-range and the frequency and duration of hypo- and hyperglycemic episodes will be assessed via stored glucose data on patients FGM devices. The other secondary outcome measures will be assessed via psychometrically tested questionnaires or via patient files.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
-
Wetter, 독일, 58300
- Diabetes und Stoffwechselpraxis Wetter
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Intensified insulin therapy / insulin pump therapy
- previous participation in a structured diabetes education program
- HbA1c ≥ 7,5% but ≤ 14%
- Reduction of HbA1c as therapeutic goal
- Indication for using FGM
- Ability to understand, speak and write German language
- informed consent (if necessary, informed consent of the parents)
Exclusion Criteria:
- Diabetes duration < 1 year
- Type 2 diabetes without insulin or non-intensified insulin therapy
- severe organic disease preventing a regular participation in the training course
- pregnancy
- severe cognitive impairment
- current treatment of psychiatric disorder
- renal disease requiring dialysis
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: FLASH
Intervention: Conduct of the newly developed treatment and education program for patients with diabetes who use flash glucose monitoring (FLASH). FLASH consists of 4 lessons focusing on empowering patients to autonomously use flash glucose monitoring (FGM) in their daily routine. Patients learn to effectively interpret the different information provided by FGM in order to improve not only glycemic control but also to improve the implementation of insulin therapy in daily life. Psychological and motivational aspects of living with diabetes and handling of the FGM are addressed as well. |
Treatment and education program based on the self-management theory of behavioral medicine.
The program is delivered by certified and specially trained diabetes educators.
|
|
간섭 없음: Waiting List
Diabetic patients using FGM receive treatment as usual until the last measurement point.
After completion of the study, they are offered participation in the FLASH program.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Changes in Glycemic Control Measured by A1c
기간: 6 months
|
Difference between baseline A1c and A1c at the 6-month follow-up
|
6 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Changes in "time-in-range"
기간: 6 months
|
Difference in the duration of glycemic values spent between 70 mg/dl and 180 mg/dl between baseline and the 6-month follow-up
|
6 months
|
|
Changes in hypoglycemic episodes
기간: 6 months
|
Differences between the frequency of hypoglycemic glucose values (<70 mg/dl) (baseline vs. follow-up)
|
6 months
|
|
Changes in the duration of hypoglycemic episodes
기간: 6 months
|
Differences between the duration of hypoglycemic glucose values (<70 mg/dl) (baseline vs. follow-up)
|
6 months
|
|
Changes in hyperglycemic episodes
기간: 6 months
|
Differences between the frequency of hyperglycemic glucose values (>180 mg/dl) (baseline vs. follow-up)
|
6 months
|
|
Changes in the duration of hyperglycemic episodes
기간: 6 months
|
Differences between the duration of hyperglycemic glucose values (>180 mg/dl) (baseline vs. follow-up)
|
6 months
|
|
Hypoglycaemia Awareness
기간: 6 months
|
The hypoglycemia awareness questionnaire provides a score indicating the severity of hypoglycaemia unawareness.
This scale ranges from 0 (maximum hypoglycaemia awareness) to 7 (minimum hypoglycaemia awareness), where a score of 4 suggests reduced hypoglycaemia awareness.
|
6 months
|
|
Diabetes Empowerment
기간: 6 months
|
Empowerment is measured by a German version of the Diabetes Empowerment Scale, a measure of diabetes-related psychosocial self-efficacy.
|
6 months
|
|
Diabetes Distress
기간: 6 months
|
The Diabetes Distress Scale (DDS-28) assesses diabetes-related stressors due to living and treating diabetes.
Different aspects of distress are covered such as hypoglycemia-related distress, physician-related distress
|
6 months
|
|
Problem Areas in Diabetes
기간: 6 months
|
The Problem Areas in Diabetes Scale (PAID) assesses the psychosocial adaptation to the burden of living with and treating diabetes.
|
6 months
|
|
Depressive symptoms
기간: 6 months
|
The presence and extent of typical depressive symptoms are assessed via self-report.
|
6 months
|
공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Norbert Hermanns, PhD, Forschungsinstitut der Diabetes Akademie Mergentheim (FIDAM GmbH)
간행물 및 유용한 링크
일반 간행물
- Hermanns N, Ehrmann D, Schipfer M, Kroger J, Haak T, Kulzer B. The impact of a structured education and treatment programme (FLASH) for people with diabetes using a flash sensor-based glucose monitoring system: Results of a randomized controlled trial. Diabetes Res Clin Pract. 2019 Apr;150:111-121. doi: 10.1016/j.diabres.2019.03.003. Epub 2019 Mar 4.
- Schipfer M, Albrecht C, Ehrmann D, Haak T, Kulzer B, Hermanns N. Makes FLASH the difference between the intervention group and the treatment-as-usual group in an evaluation study of a structured education and treatment programme for flash glucose monitoring devices in people with diabetes on intensive insulin therapy: study protocol for a randomised controlled trial. Trials. 2018 Feb 5;19(1):91. doi: 10.1186/s13063-018-2479-9.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- NH052017
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
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. .
진성 당뇨병에 대한 임상 시험
-
Fondazione Policlinico Universitario Agostino Gemelli...아직 모집하지 않음비만 | 제2형 당뇨병 | 인슐린 저항성 당뇨병 (Mellitus)