Closed-loop Medtronic 780G System in Youth With Type 1 Diabetes

Type 1 Diabetes Clinical Trial

Official title:

Title: Closed-loop Medtronic 780G System in Youth With Type 1 Diabetes: AWeSoMe Study Group Prospective Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05908708
• Other study ID #: SHEBA-22-9609-NG-CTIL
• Status: Recruiting
• Start date: June 1, 2023
• Est. completion date: June 1, 2024

Study information

• Verified date: November 2023
• Source: Sheba Medical Center
• Contact: Noah Gruber, MD
• Phone: +972507181666
• Email: noah.gruber[@]sheba.health.gov.il
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Child, Only
• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

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

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Ramat Gan	Please Select

Sponsors (5)

Lead Sponsor	Collaborator
Sheba Medical Center	Assaf-Harofeh Medical Center, Maccabi Healthcare Services, Israel, Tel-Aviv Sourasky Medical Center, Wolfson Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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 mellit — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	HbA1c as assessed from point-of-care clinic visit	Change in HbA1c from baseline to three months of closed-loop Medtronic 780G system	0, 3 months
Secondary	HbA1c as assessed from point-of-care clinic visit	Change in HbA1c from baseline to six months of closed-loop Medtronic 780G system	0, 6 months
Secondary	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	0, 3 months
Secondary	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	0, 6 months
Secondary	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	0, 3 months
Secondary	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	0, 6 months
Secondary	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	0, 3 months
Secondary	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	0, 6 months
Secondary	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	0, 3 months
Secondary	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	0, 6 months
Secondary	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.	0, 6 months
Secondary	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.	0, 6 months
Secondary	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.	0, 6 months
Secondary	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.	0, 6 months
Secondary	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.	0, 6 months
Secondary	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.	0, 6 months
Secondary	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.	0, 6 months
Secondary	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.	0, 6 months
Secondary	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.	0, 6 months