An Open-label, Two-center, Randomized, Cross-over Study to Evaluate the Safety and Efficacy of Glycemic Control Using Hybrid-closed Loop vs. Advanced Hybrid Closed-loop in Young Subjects With Type 1 Diabetes

NCT04269668 | Completed FDA Device

• 1 other identifier: RMC077719ctil
• Study Type: interventional
• Target: 28
• Locations: 2 countries
• Sites: 2

Brief Summary

Closed-loop systems are becoming an integral part of diabetes management. These systems were uniformly proven to improve glycemic control, reduce hyperglycemia and hypoglycemia while modestly reducing HbA1c levels and improving quality of life. While overnight control is close to optimal under closed loop control, postprandial hyperglycemia during daytime remains a challenge. The advanced hybrid closed loop system was designed with an improved auto-basal control and additional auto-bolus module that delivers correction boluses automatically. In addition, this system was developed to improve user experience by significantly reducing the amount of alarms and exits from Auto Mode. Therefore, this system might have an advance in treating hyperglycemia over the hybrid closed loop that controls glucose levels by modulation of insulin basal rate only. Therefore, we propose the current study that will compare 6 weeks glycemic control using hybrid closed loop versus advanced hybrid closed loop that add correction boluses among young children and adolescents. The objective of this study is to evaluate and compare the safety and efficacy of 6 weeks glucose control using Hybrid Closed Loop (HCL-670G) compared to Advanced Hybrid Closed Loop System (AHCL- 670G) in young subjects with sub-optimally controlled type 1 diabetes. A total of 28 subjects (age 7-14 years) will be enrolled at two investigational centers. At the end of the cross-over study participants will be offered with an extension period, during which they will be offered to use their preferred closed-loop system for another 3 months

Conditions

Diabetes Mellitus, Type 1

Keywords

Hybrid Closed Loop; Closed Loop; Artificial Pancreas

Outcome Measures

Primary Outcomes (2)

• Percentage of time of glucose sensor readings within 70 to 180 mg/dl

  6 weeks for each arm of the crossover, day 90 of the extension period

• Percentage of time of glucose sensor readings below 54 mg/dl

  6 weeks for each arm of the crossover

Secondary Outcomes (14)

• Percentage of time of glucose levels spent below 70 mg/dl

  6 weeks for each arm of the crossover, day 90 of the extension period

• Percentage of time of glucose levels spent above 180 mg/dl

  6 weeks for each arm of the crossover, day 90 of the extension period

• Average glucose sensor readings

  6 weeks for each arm of the crossover, day 90 of the extension period

• Standard deviation of glucose sensor readings

  6 week for each arm of the crossover, day 90 of the extension period

• Fasting blood glucose levels

  6 weeks for each arm of the crossover, day 90 of the extension period

Other Outcomes (5)

• Percentage of time of glucose sensor readings below 60 mg/dl

  6 weeks for each arm of the crossover

• Percentage of time of glucose sensor readings above 250mg/dl

  6 weeks for each arm of the crossover

• Percentage of time of glucose sensor readings above 300mg/dl

  6 weeks for each arm of the crossover

Study Arms (2)

Medtronic Minimed 670G 3.0 HCL

ACTIVE COMPARATOR

Hybrid closed loop system

Device: Medtronic Minimed 670G 3.0 HCL

Medtronic Minimed 670G 4.0 AHCL

EXPERIMENTAL

Advanced hybrid closed loop system

Device: Medtronic Minimed 670G 4.0 AHCL

Interventions

Medtronic Minimed 670G 3.0 HCL DEVICE

Hybrid closed loop system

Medtronic Minimed 670G 3.0 HCL

Medtronic Minimed 670G 4.0 AHCL DEVICE

Advanced hybrid closed loop system

Medtronic Minimed 670G 4.0 AHCL

Eligibility Criteria

• Age: 7 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Diabetes type 1 duration \>1 year since diagnosis
• Pump therapy for at least 3 months and experience with sensor use
• Age \>=7 years up to 14 years
• A1C\>7.5% and \<10.0%
• BMI SDS below the 95th percentile for age
• Subjects who live with at least one other adult person, who will be trained in managing an emergent hypoglycemia and who is able to contact the study subject any time
• Subjects/caregivers capable of operating a computer-based system

You may not qualify if:

• Subject is unable to tolerate tape adhesive in the area of sensor placement
• Subject has any unresolved adverse skin condition in the area of sensor or device placement (e.g., psoriasis, rash, Staphylococcus infection)
• Subject is actively participating in an investigational study (drug or device) wherein they have received treatment from an investigational study drug or device in the last 2 weeks
• Subject has a positive pregnancy screening test
• Subject is female, sexually active without the use of contraception, and plans/able to become pregnant during the course of the study and is not using an acceptable method of contraception or breast feeding women
• Subject has had hypoglycemia resulting in loss of consciousness with or without seizure within the past 6 months prior to screening visit
• Subject has had an episode of diabetic ketoacidosis (DKA) within the past 6 months prior to screening visit
• Subject has a history of a seizure disorder
• Subject has central nervous system or cardiac disorder resulting in syncope
• Subject has eating disorder
• Subjects with a history of adrenal insufficiency or chronic renal diseases
• Subjects with history of migraines that have occurred at least 2 times in the last 3 months prior to enrollment
• Any disease or condition that may influence the A1C testing e.g. abnormal red blood cell indices and iron deficiency, sickle cell disease, hemoglobinopathy
• Subject needs to travel by air during the study duration
• Medication influencing coagulation as Marcumar or systemic Xa-Antagonists -Untreated coeliac disease (Transglutaminase in the last 6 months elevated 2x\>upper limit)

Sponsors & Collaborators

• Rabin Medical Center: lead
• GIF: collaborator
• Medtronic: collaborator

Study Sites (2)

Diabetes -Zentrum fuer kinder und jugendliche

Hanover, Germany

Location

Schneider Children's Medical Center of Israel

Petah Tikva, 4920235, Israel

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2020
• First Posted: February 17, 2020
• Study Start: July 19, 2020
• Primary Completion: February 20, 2021
• Study Completion: March 20, 2021
• Last Updated: February 22, 2022

Record last verified: 2021-02

Locations

IL (1); DE (1)