NCT05908708

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
2mo left

Started Jun 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Jun 2023Jul 2026

First Submitted

Initial submission to the registry

May 27, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

June 18, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

April 9, 2026

Status Verified

April 1, 2026

Enrollment Period

3.1 years

First QC Date

May 27, 2023

Last Update Submit

April 3, 2026

Conditions

Type 1 DiabetesChild, Only

Keywords

TechnologyInsulin pump

Outcome Measures

Primary Outcomes (4)

  • 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

    0,3 months

  • 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

    0,6 months

  • 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

    0,12 months

  • 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

    0,24 months

Secondary Outcomes (37)

  • HbA1c as assessed from point-of-care clinic visit

    0, 3 months

  • HbA1c as assessed from point-of-care clinic visit

    0, 6 months

  • Time spent below range (≤ 70 mg/dL) as assessed from closed-loop Medtronic 780G system

    0, 3 months

  • Time spent below range (≤ 70 mg/dL) as assessed from closed-loop Medtronic 780G system

    0, 6 months

  • Time spent below range (≤ 54 mg/dL) as assessed from closed-loop Medtronic 780G system

    0, 3 months

  • +32 more secondary outcomes

Interventions

Medtronic 780G® hybrid closed loopDEVICE

Medtronic 780G® hybrid closed loop system uses the commercial "auto-mode" with an insulin pump and continuous glucose monitoring.

Eligibility Criteria

Age1 Year - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study 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.

You may qualify if:

  • Diagnosis of type 1 diabetes Diabetes duration ≥ 6 months Routine attendance at clinic visits Initiation of 780G system usage

You may not qualify if:

  • Children under the age of 1 year Children without 780G system

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba Medical Center

Ramat Gan, Please Select, 5265601, Israel

RECRUITING

Related Publications (7)

  • Mehta SN, Nansel TR, Volkening LK, Butler DA, Haynie DL, Laffel LM. Validation of a contemporary adherence measure for children with Type 1 diabetes: the Diabetes Management Questionnaire. Diabet Med. 2015 Sep;32(9):1232-8. doi: 10.1111/dme.12682. Epub 2015 Jan 30.

    PMID: 26280463BACKGROUND

  • Skinner TC, Hoey H, McGee HM, Skovlund SE; Hvidore Study Group on Childhood Diabetes. 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. Diabetologia. 2006 Apr;49(4):621-8. doi: 10.1007/s00125-005-0124-0. Epub 2006 Jan 26.

    PMID: 16525844RESULT

  • Gaudry E, Vagg P, Spielberger CD. Validation of the State-Trait Distinction in Anxiety Research. Multivariate Behav Res. 1975 Jul 1;10(3):331-41. doi: 10.1207/s15327906mbr1003_6.

    PMID: 26829634RESULT

  • Gonder-Frederick L, Nyer M, Shepard JA, Vajda K, Clarke W. Assessing fear of hypoglycemia in children with Type 1 diabetes and their parents. Diabetes Manag (Lond). 2011;1(6):627-639. doi: 10.2217/DMT.11.60.

    PMID: 22180760RESULT

  • Rovner AJ, Nansel TR, Mehta SN, Higgins LA, Haynie DL, Laffel LM. Development and validation of the type 1 diabetes nutrition knowledge survey. Diabetes Care. 2012 Aug;35(8):1643-7. doi: 10.2337/dc11-2371. Epub 2012 Jun 4.

    PMID: 22665217RESULT

  • Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.

    PMID: 2748771RESULT

  • Gruber N, Wittenberg A, Brener A, Abiri S, Mazor-Aronovitch K, Yackobovitch-Gavan M, Averbuch S, Ben Ari T, Levek N, Levran N, Landau Z, Rachmiel M, Pinhas-Hamiel O, Lebenthal Y. Real-Life Achievements of MiniMed 780G Advanced Closed-Loop System in Youth with Type 1 Diabetes: AWeSoMe Study Group Multicenter Prospective Trial. Diabetes Technol Ther. 2024 Nov;26(11):869-880. doi: 10.1089/dia.2024.0148. Epub 2024 May 31.

    PMID: 38758194DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Central Study Contacts

Noah Gruber, MD

CONTACT

+972507181666noah.gruber@sheba.health.gov.il

Elinor Mauda, BSc

CONTACT

+972543550783Elinor.Mauda@sheba.health.gov.il

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pediatric endocrinologist

Study Record Dates

First Submitted

May 27, 2023

First Posted

June 18, 2023

Study Start

June 1, 2023

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

April 9, 2026

Record last verified: 2026-04

Locations

IL(1)