Type 1 DiabetesNCT05908708
Closed-loop Medtronic 780G System in Youth With Type 1 Diabetes
An observational study of Type 1 Diabetes and Child, Only, run by Sheba Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 21 years
- Conditions the study is for
- Type 1 Diabetes, Child, Only
- What is being tested?
- Medtronic 780G® hybrid closed loop
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jun 2023to 1 Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- Diagnosis of type 1 diabetes Diabetes duration ≥ 6 months Routine attendance at clinic visits Initiation of 780G system usage
Who cannot join
- Children under the age of 1 year Children without 780G system
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Sheba Medical Center
Ramat Gan, Please Select, 5265601
Noah Gruber, 0507181666, noahgruber@gmail.com
Elinor Mauda, +972543550783, Elinor.Mauda@sheba.health.gov.il
About this study
Official title: Title: Closed-loop Medtronic 780G System in Youth With Type 1 Diabetes: AWeSoMe Study Group Prospective 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.
Read the detailed description
Patients and Methods:
The study population will include individuals with type 1 diabetes ages 7-18 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.
Study design:
A prospective multi-center study (AWeSoMe Study Group) of type 1 diabetes patients using the closed-loop Medtronic 780G system as compared to their previous treatment regimen.
Data will be collected at 6 timepoints: baseline (at initiation of 780G system), after 1 month, three months and 6 months, 1 year, and 2 years of the closed-loop Medtronic 780G system usage.
Data collection:
All the data collected are available for healthcare providers (doctors, nurses and dieticians) as part of the routine diabetes clinic visit. The information retrieved from the medical files will include sociodemographic characteristics (current age, sex, socioeconomic position by home address, parent's education level, marital status of parents), anthropometric parameters (height, weight and body mass index), pubertal status, physical activity levels and diabetes-related characteristics. Diabetes-related characteristics: age at diagnosis, autoimmune co-morbidities (thyroid disease and Celiac), glycated hemoglobin (HbA1c) and acute complications (severe hypoglycemic episodes and DKA). Insulin pump and CGM downloaded data retrieved during the 2 weeks prior to the clinic visit: mode of insulin therapy (previous and current), total daily insulin dose (Units/kg/day), total daily carbohydrates (grams/day) and CGM metrics. CGM metrics will include: percent time CGM active, mean glucose level, standard deviation (SD), coefficient of variability (CV), time in range (TIR), time above range (TAR), time below range (TBR) and glucose management indicator (GMI). Closed-loop Medtronic 780G system user evaluation: reason for switching from conventional treatment to closed-loop, automode system exits and patient's/parent's perception of closed-loop system.
In addition to the data mentioned above the following data will be collected:
- Questionnaires for the:
- Patients - the quality of life, anxiety, fear of hypoglycemia - child, diabetes management, and nutrition knowledge in diabetes. All of the questionnaires are validated and were translated into Hebrew using the globally-accepted linguistic validation procedure.
- Parents - the quality of life, fear of hypoglycemia - parent, diabetes management, sleep quality, and nutrition knowledge in diabetes. All of the questionnaires are validated and were translated into Hebrew using the globally-accepted linguistic validation procedure.
- Bioimpedance parameters
- Diet - nutrition evaluation through 3-daily diet notes
- Sleep - sleep evaluation through parents' 3-daily sleep diaries
- Conditions
- Type 1 Diabetes, Child, Only
- Being tested
- Medtronic 780G® hybrid closed loop
- Keywords
- Technology, Insulin pump
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medtronic 780G® hybrid closed loopDevice
Medtronic 780G® hybrid closed loop system uses the commercial "auto-mode" with an insulin pump and continuous glucose monitoring.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 0,24 months
Secondary outcomes (37)
HbA1c as assessed from point-of-care clinic visit
Change in HbA1c from baseline to three months of closed-loop Medtronic 780G system
Measured: 0, 3 months
HbA1c as assessed from point-of-care clinic visit
Change in HbA1c from baseline to six months of closed-loop Medtronic 780G system
Measured: 0, 6 months
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
Measured: 0, 3 months
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
Measured: 0, 6 months
Time spent below range (≤ 54 mg/dL) as assessed from closed-loop Medtronic 780G system
Change in time spent below range (≤ 54 mg/dL) baseline to three months of closed-loop Medtronic 780G system
Measured: 0, 3 months
Time spent below range (≤ 54 mg/dL) as assessed from closed-loop Medtronic 780G system
Change in time spent below range (≤ 54 mg/dL) baseline to six months of closed-loop Medtronic 780G system
Measured: 0, 6 months
Time spent above range (> 180 mg/dL) as assessed from closed-loop Medtronic 780G system
Change in time spent above range (> 180 mg/dL) baseline to three months of closed-loop Medtronic 780G system
Measured: 0, 3 months
Time spent above range (> 180 mg/dL) as assessed from closed-loop Medtronic 780G system
Change in time spent above range (> 180 mg/dL) baseline to six months of closed-loop Medtronic 780G system
Measured: 0, 6 months
Time spent above range (> 250 mg/dL) as assessed from closed-loop Medtronic 780G system
Change in time spent above range (> 250 mg/dL) baseline to three months of closed-loop Medtronic 780G system
Measured: 0, 3 months
Time spent above range (> 250 mg/dL) as assessed from closed-loop Medtronic 780G system
Delta time spent above range (> 250 mg/dL) baseline to six months of closed-loop Medtronic 780G system
Measured: 0, 6 months
Quality of life - child as assessed by a questionnaire
Change in quality of life - baseline to 6 months. A validated questionnaire, as cited in the Reference section. Min score 5, max score 100; the higher the score, the better quality of life.
Measured: 0, 6 months
Quality of life - parent as assessed by a questionnaire
Change in quality of life - baseline to 6 months. A validated questionnaire, as cited in the Reference section. Min score 37, max score 185; the higher the score, the better quality of life.
Measured: 0, 6 months
Trait anxiety - child as assessed by a questionnaire
Change in trait anxiety - baseline to 6 months. A validated questionnaire, as cited in the Reference section. Min score 20, max score 80; the higher the score, the higher the anxiety.
Measured: 0, 6 months
Fear of hypoglycemia - child as assessed by a questionnaire
Change in fear of hypoglycemia - baseline to 6 months. A validated questionnaire, as cited in the Reference section. Min score 25, max score 100; the higher the score, the higher the fear of hypoglycemia.
Measured: 0, 6 months
Fear of hypoglycemia - parent as assessed by a questionnaire
Change in fear of hypoglycemia - baseline to 6 months. A validated questionnaire, as cited in the Reference section. Min score 25, max score 100; the higher the score, the higher the fear of hypoglycemia.
Measured: 0, 6 months
Diabetes management - child as assessed by a questionnaire
Change in diabetes management - baseline to 6 months. A validated questionnaire, as cited in the Reference section. Min score 20, max score 100; the higher the score, the better the management of diabetes.
Measured: 0, 6 months
Diabetes management - parent as assessed by a questionnaire
Change in diabetes management - baseline to 6 months. A validated questionnaire, as cited in the Reference section. Min score 20, max score 100; the higher the score, the better the management of diabetes.
Measured: 0, 6 months
Nutrition diaries as assessed by a dietician
Change in carbohydrates grams - baseline to 6 months. Assessment of carbohydrates in grams by a certified pediatric nutritionist.
Measured: 0, 6 months
Sleep quality as assessed by a questionnaire
Change in sleep quality - baseline to 6 months, as assessed by a validated questionnaire, as cited in the Reference section.
Measured: 0, 6 months
HbA1c as assessed from point-of-care clinic visit
Change in HbA1c from baseline to six months of closed-loop Medtronic 780G system
Measured: 0, 12 months
HbA1c as assessed from point-of-care clinic visit
Change in HbA1c from baseline to six months of closed-loop Medtronic 780G system
Measured: 0, 24 months
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
Measured: 0, 12 months
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
Measured: 0, 24 months
Time spent below range (≤ 54 mg/dL) as assessed from closed-loop Medtronic 780G system
Change in time spent below range (≤ 54 mg/dL) baseline to six months of closed-loop Medtronic 780G system
Measured: 0, 12 months
Time spent below range (≤ 54 mg/dL) as assessed from closed-loop Medtronic 780G system
Change in time spent below range (≤ 54 mg/dL) baseline to six months of closed-loop Medtronic 780G system
Measured: 0, 24 months
Time spent above range (> 180 mg/dL) as assessed from closed-loop Medtronic 780G system
Change in time spent above range (> 180 mg/dL) baseline to six months of closed-loop Medtronic 780G system
Measured: 0, 12 months
Time spent above range (> 180 mg/dL) as assessed from closed-loop Medtronic 780G system
Change in time spent above range (> 180 mg/dL) baseline to six months of closed-loop Medtronic 780G system
Measured: 0, 24 months
Time spent above range (> 250 mg/dL) as assessed from closed-loop Medtronic 780G system
Delta time spent above range (> 250 mg/dL) baseline to six months of closed-loop Medtronic 780G system
Measured: 0, 12 months
Time spent above range (> 250 mg/dL) as assessed from closed-loop Medtronic 780G system
Delta time spent above range (> 250 mg/dL) baseline to six months of closed-loop Medtronic 780G system
Measured: 0, 24 months
Quality of life - parent as assessed by a questionnaire
Change in quality of life - baseline to 6 months. A validated questionnaire, as cited in the Reference section. Min score 37, max score 185; the higher the score, the better quality of life.
Measured: 0, 24 months
Trait anxiety - child as assessed by a questionnaire
Change in trait anxiety - baseline to 6 months. A validated questionnaire, as cited in the Reference section. Min score 20, max score 80; the higher the score, the higher the anxiety.
Measured: 0, 24 months
Fear of hypoglycemia - child as assessed by a questionnaire
Change in fear of hypoglycemia - baseline to 6 months. A validated questionnaire, as cited in the Reference section. Min score 25, max score 100; the higher the score, the higher the fear of hypoglycemia.
Measured: 0, 24 months
Fear of hypoglycemia - parent as assessed by a questionnaire
Change in fear of hypoglycemia - baseline to 6 months. A validated questionnaire, as cited in the Reference section. Min score 25, max score 100; the higher the score, the higher the fear of hypoglycemia.
Measured: 0, 24 months
Diabetes management - child as assessed by a questionnaire
Change in diabetes management - baseline to 6 months. A validated questionnaire, as cited in the Reference section. Min score 20, max score 100; the higher the score, the better the management of diabetes.
Measured: 0, 24 months
Diabetes management - parent as assessed by a questionnaire
Change in diabetes management - baseline to 6 months. A validated questionnaire, as cited in the Reference section. Min score 20, max score 100; the higher the score, the better the management of diabetes.
Measured: 0, 24 months
Nutrition diaries as assessed by a dietician
Change in carbohydrates grams - baseline to 6 months. Assessment of carbohydrates in grams by a certified pediatric nutritionist.
Measured: 0, 24 months
Sleep quality as assessed by a questionnaire
Change in sleep quality - baseline to 6 months, as assessed by a validated questionnaire, as cited in the Reference section.
Measured: 0, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start1 Jun 2023
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Collaborators
- Tel-Aviv Sourasky Medical Center, Maccabi Healthcare Services, Israel, Wolfson Medical Center, Assaf-Harofeh Medical Center
- Responsible party
- Principal investigator, Dr. Noah Gruber, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05908708
- Sponsor's protocol ID
- SHEBA-22-9609-NG-CTIL
- Status last verified
- Apr 2026
- First submitted
- 27 May 2023
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: If requested, we will share the data collection system as needed.
Publications
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.
PubMed 26280463Skinner 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.
PubMed 16525844Gaudry 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.
PubMed 26829634Gonder-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.
PubMed 22180760Rovner 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.
PubMed 22665217Buysse 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.
PubMed 2748771Gruber 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.
PubMed 38758194
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Title: Closed-loop Medtronic 780G System in Youth With Type 1 Diabetes: AWeSoMe Study Group Prospective Trial
- ClinicalTrials.gov ID
- NCT05908708
- Acronym / sponsor ID
- SHEBA-22-9609-NG-CTIL
- Conditions
- Type 1 Diabetes, Child, Only
- Keywords
- Technology, Insulin pump
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Collaborators
- Tel-Aviv Sourasky Medical Center, Maccabi Healthcare Services, Israel, Wolfson Medical Center, Assaf-Harofeh Medical Center
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 18 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients and Methods:
The study population will include individuals with type 1 diabetes ages 7-18 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.
Study design:
A prospective multi-center study (AWeSoMe Study Group) of type 1 diabetes patients using the closed-loop Medtronic 780G system as compared to their previous treatment regimen.
Data will be collected at 6 timepoints: baseline (at initiation of 780G system), after 1 month, three months and 6 months, 1 year, and 2 years of the closed-loop Medtronic 780G system usage.
Data collection:
All the data collected are available for healthcare providers (doctors, nurses and dieticians) as part of the routine diabetes clinic visit. The information retrieved from the medical files will include sociodemographic characteristics (current age, sex, socioeconomic position by home address, parent's education level, marital status of parents), anthropometric parameters (height, weight and body mass index), pubertal status, physical activity levels and diabetes-related characteristics. Diabetes-related characteristics: age at diagnosis, autoimmune co-morbidities (thyroid disease and Celiac), glycated hemoglobin (HbA1c) and acute complications (severe hypoglycemic episodes and DKA). Insulin pump and CGM downloaded data retrieved during the 2 weeks prior to the clinic visit: mode of insulin therapy (previous and current), total daily insulin dose (Units/kg/day), total daily carbohydrates (grams/day) and CGM metrics. CGM metrics will include: percent time CGM active, mean glucose level, standard deviation (SD), coefficient of variability (CV), time in range (TIR), time above range (TAR), time below range (TBR) and glucose management indicator (GMI). Closed-loop Medtronic 780G system user evaluation: reason for switching from conventional treatment to closed-loop, automode system exits and patient's/parent's perception of closed-loop system.
In addition to the data mentioned above the following data will be collected:
- Questionnaires for the:
- Patients - the quality of life, anxiety, fear of hypoglycemia - child, diabetes management, and nutrition knowledge in diabetes. All of the questionnaires are validated and were translated into Hebrew using the globally-accepted linguistic validation procedure.
- Parents - the quality of life, fear of hypoglycemia - parent, diabetes management, sleep quality, and nutrition knowledge in diabetes. All of the questionnaires are validated and were translated into Hebrew using the globally-accepted linguistic validation procedure.
- Bioimpedance parameters
- Diet - nutrition evaluation through 3-daily diet notes
- Sleep - sleep evaluation through parents' 3-daily sleep diaries
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (1 listed)
- Diagnosis of type 1 diabetes Diabetes duration ≥ 6 months Routine attendance at clinic visits Initiation of 780G system usage
Key exclusion criteria (1 listed)
- Children under the age of 1 year Children without 780G system
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medtronic 780G® hybrid closed loopMedtronic 780G® hybrid closed loop system uses the commercial "auto-mode" with an insulin pump and continuous glucose monitoring. | Device | – |
Primary outcome
Time spent in range (70-180 mg/dL) as assessed from closed-loop Medtronic 780G system
Time frame: 0,3 months
Change in time spent in range (70-180 mg/dL) from baseline to three months of closed-loop Medtronic 780G system
Time spent in range (70-180 mg/dL) as assessed from closed-loop Medtronic 780G system
Time frame: 0,6 months
Change in time spent in range (70-180 mg/dL) from baseline to six months of closed-loop Medtronic 780G system
Time spent in range (70-180 mg/dL) as assessed from closed-loop Medtronic 780G system
Time frame: 0,12 months
Change in time spent in range (70-180 mg/dL) from baseline to six months of closed-loop Medtronic 780G system
Time spent in range (70-180 mg/dL) as assessed from closed-loop Medtronic 780G system
Time frame: 0,24 months
Change in time spent in range (70-180 mg/dL) from baseline to six months of closed-loop Medtronic 780G system
37 secondary outcomes
HbA1c as assessed from point-of-care clinic visit
Time frame: 0, 3 months
HbA1c as assessed from point-of-care clinic visit
Time frame: 0, 6 months
Time spent below range (≤ 70 mg/dL) as assessed from closed-loop Medtronic 780G system
Time frame: 0, 3 months
Time spent below range (≤ 70 mg/dL) as assessed from closed-loop Medtronic 780G system
Time frame: 0, 6 months
Time spent below range (≤ 54 mg/dL) as assessed from closed-loop Medtronic 780G system
Time frame: 0, 3 months
Time spent below range (≤ 54 mg/dL) as assessed from closed-loop Medtronic 780G system
Time frame: 0, 6 months
Time spent above range (> 180 mg/dL) as assessed from closed-loop Medtronic 780G system
Time frame: 0, 3 months
Time spent above range (> 180 mg/dL) as assessed from closed-loop Medtronic 780G system
Time frame: 0, 6 months
Time spent above range (> 250 mg/dL) as assessed from closed-loop Medtronic 780G system
Time frame: 0, 3 months
Time spent above range (> 250 mg/dL) as assessed from closed-loop Medtronic 780G system
Time frame: 0, 6 months
Quality of life - child as assessed by a questionnaire
Time frame: 0, 6 months
Quality of life - parent as assessed by a questionnaire
Time frame: 0, 6 months
Trait anxiety - child as assessed by a questionnaire
Time frame: 0, 6 months
Fear of hypoglycemia - child as assessed by a questionnaire
Time frame: 0, 6 months
Fear of hypoglycemia - parent as assessed by a questionnaire
Time frame: 0, 6 months
Diabetes management - child as assessed by a questionnaire
Time frame: 0, 6 months
Diabetes management - parent as assessed by a questionnaire
Time frame: 0, 6 months
Nutrition diaries as assessed by a dietician
Time frame: 0, 6 months
Sleep quality as assessed by a questionnaire
Time frame: 0, 6 months
HbA1c as assessed from point-of-care clinic visit
Time frame: 0, 12 months
HbA1c as assessed from point-of-care clinic visit
Time frame: 0, 24 months
Time spent below range (≤ 70 mg/dL) as assessed from closed-loop Medtronic 780G system
Time frame: 0, 12 months
Time spent below range (≤ 70 mg/dL) as assessed from closed-loop Medtronic 780G system
Time frame: 0, 24 months
Time spent below range (≤ 54 mg/dL) as assessed from closed-loop Medtronic 780G system
Time frame: 0, 12 months
Time spent below range (≤ 54 mg/dL) as assessed from closed-loop Medtronic 780G system
Time frame: 0, 24 months
Time spent above range (> 180 mg/dL) as assessed from closed-loop Medtronic 780G system
Time frame: 0, 12 months
Time spent above range (> 180 mg/dL) as assessed from closed-loop Medtronic 780G system
Time frame: 0, 24 months
Time spent above range (> 250 mg/dL) as assessed from closed-loop Medtronic 780G system
Time frame: 0, 12 months
Time spent above range (> 250 mg/dL) as assessed from closed-loop Medtronic 780G system
Time frame: 0, 24 months
Quality of life - parent as assessed by a questionnaire
Time frame: 0, 24 months
Trait anxiety - child as assessed by a questionnaire
Time frame: 0, 24 months
Fear of hypoglycemia - child as assessed by a questionnaire
Time frame: 0, 24 months
Fear of hypoglycemia - parent as assessed by a questionnaire
Time frame: 0, 24 months
Diabetes management - child as assessed by a questionnaire
Time frame: 0, 24 months
Diabetes management - parent as assessed by a questionnaire
Time frame: 0, 24 months
Nutrition diaries as assessed by a dietician
Time frame: 0, 24 months
Sleep quality as assessed by a questionnaire
Time frame: 0, 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Background: PubMed 26280463Mehta 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.
- Results publication: PubMed 16525844Skinner 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.
- Results publication: PubMed 26829634Gaudry 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.
- Results publication: PubMed 22180760Gonder-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.
- Results publication: PubMed 22665217Rovner 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.
- Results publication: PubMed 2748771Buysse 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.
- Derived from this study: PubMed 38758194Gruber 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.
- Individual participant dataSharing planned: Undecided. If requested, we will share the data collection system as needed.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes and Child, Only, run by Sheba Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Noah Gruber, MD (+972507181666, noah.gruber@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time spent in range (70-180 mg/dL) as assessed from closed-loop Medtronic 780G system (time frame: 0,3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05908708, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.