Feasibility and Effectiveness of Tele-diabetes Remote System on Glycemic Control and Quality of Life of Children and Youth With Type 1 Diabetes
The goal of this clinical trial is to examine the feasibility and effectiveness of a tele-diabetes remote monitoring system on managing type 1 diabetes (T1DM) among children and adolescents. The study aims to assess whether this system, which incorporates a WhatsApp-based alert system, can improve clinical outcomes, increase adherence to treatment, enhance quality of life, and reduce healthcare utilization in this population. The main questions it aims to answer are:
Does the tele-diabetes remote system improve glycemic control (e.g., time in range [TIR], frequency of hypoglycemia and hyperglycemia, HbA1c levels)? Does it enhance adherence to treatment and overall quality of life for children and youth with T1DM? Does the system reduce the number of emergency room visits for diabetic ketoacidosis (DKA) or severe hypoglycemia, hospitalizations, and overall medical costs? Researchers will compare participants who receive WhatsApp notifications (intervention group) with those receiving standard care (control group) to evaluate differences in clinical outcomes, quality of life, and healthcare burden.
Participants will:
Receive notifications via WhatsApp messages sent by a system developed by the research team, which monitors glucose trends in real-time and sends alerts when patterns (e.g., hypoglycemia, hyperglycemia) are detected.
Participate in follow-ups supported by the hybrid medical team between routine clinic visits.
연구 개요
상태
개입 / 치료
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Noah Gruber, MD
- 전화번호: +97235305015
- 이메일: noah.gruber@sheba.health.gov.il
연구 장소
-
-
-
Ramat Gan, 이스라엘
- 모병
- Sheba medical center
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Participants must have a confirmed diagnosis of Type 1 Diabetes Mellitus (T1DM).
- Participants must use Dexcome Continuous Glucose Monitoring (CGM)
- Must have access to a smartphone capable of receiving WhatsApp messages.
- Participants must use a closed-loop insulin pump system (also known as an artificial pancreas system) omnipod DIY or Tandem.
Exclusion Criteria:
- Participants who are not using Dexcome Continuous Glucose Monitoring (CGM) and a closed-loop insulin pump system
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: intervention
trends (e.g., hyperglycemia, hypoglycemia) and send automated WhatsApp alerts
|
The tele-diabetes system is a digital platform designed for remote glucose monitoring in patients with Type 1 Diabetes. The system utilizes a smart algorithm to analyze real-time glucose levels, detect trends of hyperglycemia or hypoglycemia, and send automated WhatsApp alerts to participants. These alerts provide actionable insights aimed at improving glycemic control and treatment adherence between routine clinic visits. The system also includes a monitoring dashboard accessed by researchers and clinicians, enabling them to track the alerts sent. The medical team follows a structured escalation protocol: After two consecutive alerts: A registered dietitian contacts the participant to provide personalized dietary and behavioral guidance. If an additional alert is detected after this contact: A virtual physician consultation is scheduled to adjust treatment as needed. If another alert follows: The participant is invited for an in-clinic visit for detailed evaluation and intervention |
|
간섭 없음: Control
Participants in this arm will continue with standard care for managing Type 1 Diabetes
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Glycemic control
기간: Baseline (prior to receipt of the first WhatsApp alert) and monthly assessments after the first alert, at 1 month, 2 months, and 3 months post-enrollment.
|
CGM data - TIR - time in range, TIIR- time in tight range , hypoglycemia and hyperglycemia events, GMI, CV
|
Baseline (prior to receipt of the first WhatsApp alert) and monthly assessments after the first alert, at 1 month, 2 months, and 3 months post-enrollment.
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Adherence to Treatment
기간: Baseline (prior to receipt of the first WhatsApp alert) and monthly assessments after the first alert, at 1 month, 2 months, and 3 months post-enrollment.
|
Time of CGM use
|
Baseline (prior to receipt of the first WhatsApp alert) and monthly assessments after the first alert, at 1 month, 2 months, and 3 months post-enrollment.
|
|
Number of emergency room visits with diabetic ketoacidosis (DKA) or hypoglycemia
기간: Baseline (prior to receipt of the first WhatsApp alert) and monthly assessments after the first alert, at 1 month, 2 months, and 3 months post-enrollment.
|
Number of emergency room visits with diabetic ketoacidosis (DKA) or hypoglycemia
|
Baseline (prior to receipt of the first WhatsApp alert) and monthly assessments after the first alert, at 1 month, 2 months, and 3 months post-enrollment.
|
|
Satisfaction score
기간: 3 months post-enrollment.
|
A satisfaction questionnaire of the digital tool
|
3 months post-enrollment.
|
|
Number of hospitalizations
기간: 3 months past enrollment
|
Number of hospitalizations
|
3 months past enrollment
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
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 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. .