Clinical trial NCT05908708: Closed-loop Medtronic 780G System in Youth With Type 1 Diabetes
Official title: Title: Closed-loop Medtronic 780G System in Youth With Type 1 Diabetes: AWeSoMe Study Group Prospective Trial
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Type 1 Diabetes
Child, Only
Keywords: Technology
Insulin pump
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Tel-Aviv Sourasky Medical Center
name: Assaf-Harofeh Medical Center
name: Maccabi Healthcare Services, Israel
name: Wolfson Medical Center
First posted: 2023-06-18
Enrollment: 120
Sex: ALL
Minimum age (years): 1
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_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.

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, and six months 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 4 timepoints: baseline (at initiation of 780G system), after 1 month, three months and 6 months 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:

1. Questionnaires for the:

   1. 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.
   2. 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.
2. Bioimpedance parameters
3. Diet - nutrition evaluation through 3-daily diet notes
4. Sleep - sleep evaluation through parents' 3-daily sleep diaries

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Time spent in range (70-180 mg/dL) as assessed from closed-loop Medtronic 780G system
timeFrame: 0,3 months
measure: Time spent in range (70-180 mg/dL) as assessed from closed-loop Medtronic 780G system
timeFrame: 0,6 months
Secondary outcomes:
measure: HbA1c as assessed from point-of-care clinic visit
timeFrame: 0, 3 months
measure: HbA1c as assessed from point-of-care clinic visit
timeFrame: 0, 6 months
measure: Time spent below range (≤ 70 mg/dL) as assessed from closed-loop Medtronic 780G system
timeFrame: 0, 3 months
measure: Time spent below range (≤ 70 mg/dL) as assessed from closed-loop Medtronic 780G system
timeFrame: 0, 6 months
measure: Time spent below range (≤ 54 mg/dL) as assessed from closed-loop Medtronic 780G system
timeFrame: 0, 3 months
measure: Time spent below range (≤ 54 mg/dL) as assessed from closed-loop Medtronic 780G system
timeFrame: 0, 6 months
measure: Time spent above range (> 180 mg/dL) as assessed from closed-loop Medtronic 780G system
timeFrame: 0, 3 months
measure: Time spent above range (> 180 mg/dL) as assessed from closed-loop Medtronic 780G system
timeFrame: 0, 6 months
measure: Time spent above range (> 250 mg/dL) as assessed from closed-loop Medtronic 780G system
timeFrame: 0, 3 months
measure: Time spent above range (> 250 mg/dL) as assessed from closed-loop Medtronic 780G system
timeFrame: 0, 6 months
measure: Quality of life - child as assessed by a questionnaire
timeFrame: 0, 6 months
measure: Quality of life - parent as assessed by a questionnaire
timeFrame: 0, 6 months
measure: Trait anxiety - child as assessed by a questionnaire
timeFrame: 0, 6 months
measure: Fear of hypoglycemia - child as assessed by a questionnaire
timeFrame: 0, 6 months
measure: Fear of hypoglycemia - parent as assessed by a questionnaire
timeFrame: 0, 6 months
measure: Diabetes management - child as assessed by a questionnaire
timeFrame: 0, 6 months
measure: Diabetes management - parent as assessed by a questionnaire
timeFrame: 0, 6 months
measure: Nutrition diaries as assessed by a dietician
timeFrame: 0, 6 months
measure: Sleep quality as assessed by a questionnaire
timeFrame: 0, 6 months
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
state: Please Select
Study officials:
References:
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