Closed-loop Medtronic 780G System in Youth With Type 1 Diabetes
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-21
SponsorSheba Medical Center
About this trial
The goal of this observational study is to describe data on Israeli children and youth using the 780G system including data regarding glycemic control parameters, various questionnaires, sleep data, bioimpedance measures, and dietary parameters. The main questions it aims to answer are: • whether the 780G system will improve glycemic control • whether the psychosocial aspects will improve. Participants will be followed once connected to 780G, at baseline, one, three, six months, 1 year, and two years after the connection.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
The study population will include individuals with type 1 diabetes ages 1-21 years who are managed by the pediatric diabetes teams from the AWeSoMe Study Group (five pediatric diabetes multidisciplinary clinics in Israel; Dana-Dwek Children's Hospital, Edmond and Lily Safra Children's Hospital, Maccabi National Juvenile Diabetes Center, Shamir Medical Center and Wolfson Medical Center) and who chose to purchase 780G out-of-pocket as part of their diabetes care, or are eligible according to the updated Israeli basket to receive it. The decision to use 780G will be made prior to and independent of their entrance to the study, and will be based on preferences of the patients and their parents.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Medtronic 780G® hybrid closed loop
DeviceMedtronic 780G® hybrid closed loop system uses the commercial "auto-mode" with an insulin pump and continuous glucose monitoring.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Time spent in range (70-180 mg/dL) as assessed from closed-loop Medtronic 780G system
Change in time spent in range (70-180 mg/dL) from baseline to three months of closed-loop Medtronic 780G system
Time frame
0,3 months2
Time spent in range (70-180 mg/dL) as assessed from closed-loop Medtronic 780G system
Change in time spent in range (70-180 mg/dL) from baseline to six months of closed-loop Medtronic 780G system
Time frame
0,6 months3
Time spent in range (70-180 mg/dL) as assessed from closed-loop Medtronic 780G system
Change in time spent in range (70-180 mg/dL) from baseline to six months of closed-loop Medtronic 780G system
Time frame
0,12 months4
Time spent in range (70-180 mg/dL) as assessed from closed-loop Medtronic 780G system
Change in time spent in range (70-180 mg/dL) from baseline to six months of closed-loop Medtronic 780G system
Time frame
0,24 monthsSecondary outcomes
1
HbA1c as assessed from point-of-care clinic visit
Change in HbA1c from baseline to three months of closed-loop Medtronic 780G system
Time frame
0, 3 months2
HbA1c as assessed from point-of-care clinic visit
Change in HbA1c from baseline to six months of closed-loop Medtronic 780G system
Time frame
0, 6 months3
Time spent below range (≤ 70 mg/dL) as assessed from closed-loop Medtronic 780G system
Change in time spent below range (≤ 70 mg/dL) baseline to three months of closed-loop Medtronic 780G system
Time frame
0, 3 months4
Time spent below range (≤ 70 mg/dL) as assessed from closed-loop Medtronic 780G system
Change in time spent below range (≤ 70 mg/dL and ≤ 54 mg/dL) baseline to six months of closed-loop Medtronic 780G system
Time frame
0, 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Sheba Medical Center
Lead sponsor
Tel-Aviv Sourasky Medical Center
Collaborator
Maccabi Healthcare Services, Israel
Collaborator
Wolfson Medical Center
Collaborator
Assaf-Harofeh Medical Center
Collaborator
Source ClinicalTrials.gov