Validation of a contemporary adherence measure for children with Type 1 diabetes: the Diabetes Management Questionnaire.
S N Mehta, T R Nansel, L K Volkening...
https://pubmed.ncbi.nlm.nih.gov/26280463Actively Recruiting
Age: 1Year - 21Years
All Genders
ID05908708
Closed-loop Medtronic 780G System in Youth With Type 1 Diabetes: AWeSoMe Study Group Prospective Trial
Led by Sheba Medical Center · Updated on 2026-04-09
120
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
S
Sheba Medical Center
Lead Sponsor
T
Tel-Aviv Sourasky Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to understand how the Medtronic 780G hybrid closed-loop system affects children and youth with type 1 diabetes in Israel. The study focuses on whether this system improves blood sugar control and psychosocial aspects like quality of life and anxiety. It is a prospective, observational study involving participants aged 7 to 18 years who are using or starting the 780G system as part of their diabetes care. Participants will use the Medtronic 780G system, which combines an insulin pump with continuous glucose monitoring in an automated "auto-mode". Data will be collected at six time points: baseline (start of 780G use), and after 1 month, 3 months, 6 months, 1 year, and 2 years. The study gathers information from medical records, insulin pump and glucose monitor downloads, questionnaires for both patients and parents, bioimpedance measures, dietary records, and sleep diaries. During the study, participants will attend regular diabetes clinic visits where data on demographics, diabetes history, insulin use, glucose levels, and physical activity are recorded. Questionnaires assess quality of life, anxiety, fear of low blood sugar, diabetes management, sleep quality, and nutrition knowledge. Researchers will track key outcomes like time spent in target blood sugar range and HbA1c levels over two years. The study also monitors psychosocial factors and dietary and sleep habits to understand the broader impacts of the 780G system.
CONDITIONS
Brief Title
Closed-loop Medtronic 780G System in Youth With Type 1 Diabetes
Who Can Participate
Age: 1Year - 21Years
All Genders
Eligibility Criteria
You may qualify if you...
- Diagnosis of type 1 diabetes
- Diabetes duration of 6 months or more
- Routine attendance at clinic visits
- Initiation of 780G system usage
You will not qualify if you...
- Children under the age of 1 year
- Children not using the 780G system
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - 2 years
Participants begin using the Medtronic 780G hybrid closed loop system as part of their diabetes care. Data is collected at baseline (initiation) and at multiple timepoints to assess their diabetes management and health status.
6 routine clinic visits over 2 years
Long-term Monitoring
Duration - 2 years
Participants are observed over time while using the Medtronic 780G system. Data on glucose control, quality of life, sleep, diet, and other health parameters are collected through questionnaires, diaries, and medical records during routine clinic visits.
Data collected at baseline, 1 month, 3 months, 6 months, 1 year, and 2 years
Trial Site Locations
Total: 1 location
1
Sheba Medical Center
Ramat Gan, Please Select, Israel, 5265601
Actively Recruiting
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Research Team
N
Noah Gruber, MD
E
Elinor Mauda, BSc
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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Published Research Related To This Trial
A short form of the Diabetes Quality of Life for Youth questionnaire: exploratory and confirmatory analysis in a sample of 2,077 young people with type 1 diabetes mellitus.
T C Skinner, H Hoey, H M McGee...
https://pubmed.ncbi.nlm.nih.gov/16525844Validation of the State-Trait Distinction in Anxiety Research.
E Gaudry, P Vagg, C D Spielberger
https://pubmed.ncbi.nlm.nih.gov/26829634Assessing fear of hypoglycemia in children with Type 1 diabetes and their parents.
Linda Gonder-Frederick, Maren Nyer, Jaclyn A Shepard...
https://pubmed.ncbi.nlm.nih.gov/22180760Development and validation of the type 1 diabetes nutrition knowledge survey.
Alisha J Rovner, Tonja R Nansel, Sanjeev N Mehta...
https://pubmed.ncbi.nlm.nih.gov/22665217The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research.
D J Buysse, C F Reynolds, T H Monk...
https://pubmed.ncbi.nlm.nih.gov/2748771Real-Life Achievements of MiniMed 780G Advanced Closed-Loop System in Youth with Type 1 Diabetes: AWeSoMe Study Group Multicenter Prospective Trial.
Noah Gruber, Avigail Wittenberg, Avivit Brener...
https://pubmed.ncbi.nlm.nih.gov/38758194