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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02748018




Registration number
NCT02748018
Ethics application status
Date submitted
19/04/2016
Date registered
22/04/2016
Date last updated
22/01/2024

Titles & IDs
Public title
Multi-center Trial in Adult and Pediatric Patients With Type 1 Diabetes Using Hybrid Closed Loop System and Control at Home
Scientific title
Multi-center, Randomized, Parallel, Adaptive, Controlled Trial in Adult and Pediatric Patients With Type 1 Diabetes Using Hybrid Closed Loop System and Control (CSII, MDI and SAP) at Home
Secondary ID [1] 0 0
CEP 304
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - 670G and 770G Insulin Pump
Treatment: Devices - Subject's Current Diabetes Therapy

Experimental: Hybrid Closed Loop Arm - The HCL Arm will use the MiniMed System (i.e., using Auto Mode) for 6 months during the study period.

Active comparator: Control Arm - The Control Arm will use individual subject's current diabetes therapy: CSII (Continuous Subcutaneous Insulin Infusion), MDI (Multiple Daily Injections) or SAP (Sensor Augmented Pump). Each cohort (CSII, MDI, or SAP) will be used as the control arm to be compared to the experimental arm (HCL).


Treatment: Devices: 670G and 770G Insulin Pump
Medtronic 670G and 770G Hybrid Closed Loop Systems

Treatment: Devices: Subject's Current Diabetes Therapy
Subject will use current diabetes therapy: CSII (Continuous Subcutaneous Insulin Infusion), MDI (Multiple Daily Injections) or SAP (Sensor Augmented Pump).
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
CSII Cohort: change of A1C (?A1C) for subjects with baseline A1c > 8%
Timepoint [1] 0 0
6 months
Primary outcome [2] 0 0
CSII Cohort: Time in Hypoglycemic Range for subjects with baseline A1c = 8%
Timepoint [2] 0 0
6 months
Primary outcome [3] 0 0
MDI Cohort: change of A1C (?A1C) for subjects with baseline A1c > 8%
Timepoint [3] 0 0
6 months
Primary outcome [4] 0 0
MDI Cohort: Time in Hypoglycemic Range for subjects with baseline A1c = 8%
Timepoint [4] 0 0
6 months
Primary outcome [5] 0 0
SAP Cohort: change of A1C (?A1C) for subjects with baseline A1c > 8%
Timepoint [5] 0 0
6 months
Primary outcome [6] 0 0
SAP Cohort: Time in Hypoglycemic Range for subjects with baseline A1c = 8%
Timepoint [6] 0 0
6 months
Secondary outcome [1] 0 0
CSII Cohort: Time in Hypoglycemic Range for subjects with baseline A1c > 8%
Timepoint [1] 0 0
6 months
Secondary outcome [2] 0 0
CSII Cohort: Change in A1C (?A1C) for subjects with baseline A1c = 8%
Timepoint [2] 0 0
6 months
Secondary outcome [3] 0 0
CSII Cohort: Time in Hypoglycemic Range during Night for all subjects
Timepoint [3] 0 0
6 months
Secondary outcome [4] 0 0
CSII Cohort: Time in Target Range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) during Night for all subjects
Timepoint [4] 0 0
6 months
Secondary outcome [5] 0 0
CSII Cohort: Time in Target Range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) during Day and Night for all subjects
Timepoint [5] 0 0
6 months
Secondary outcome [6] 0 0
CSII Cohort: Time in Hypoglycemic Range during Day and Night for all subjects
Timepoint [6] 0 0
6 months
Secondary outcome [7] 0 0
CSII Cohort: Change in A1C for all subjects
Timepoint [7] 0 0
6 months
Secondary outcome [8] 0 0
MDI Cohort: Time in Hypoglycemic Range for subjects with baseline A1c > 8%
Timepoint [8] 0 0
6 months
Secondary outcome [9] 0 0
MDI Cohort: Change in A1C (?A1C) for subjects with baseline A1c = 8%
Timepoint [9] 0 0
6 months
Secondary outcome [10] 0 0
MDI Cohort: Time in Hypoglycemic Range during Night for all subjects
Timepoint [10] 0 0
6 months
Secondary outcome [11] 0 0
MDI Cohort: Time in Target Range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) during Night for all subjects
Timepoint [11] 0 0
6 months
Secondary outcome [12] 0 0
MDI Cohort: Time in Target Range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) during Day and Night for all subjects
Timepoint [12] 0 0
6 months
Secondary outcome [13] 0 0
MDI Cohort: Time in Hypoglycemic Range during Day and Night for all subjects
Timepoint [13] 0 0
6 months
Secondary outcome [14] 0 0
MDI Cohort: Change in A1C for all subjects
Timepoint [14] 0 0
6 months
Secondary outcome [15] 0 0
SAP Cohort: Time in Hypoglycemic Range for subjects with baseline A1c > 8%
Timepoint [15] 0 0
6 months
Secondary outcome [16] 0 0
SAP Cohort: Change in A1C (?A1C) for subjects with baseline A1c = 8%
Timepoint [16] 0 0
6 months
Secondary outcome [17] 0 0
SAP Cohort: Time in Hypoglycemic Range during Night for all subjects
Timepoint [17] 0 0
6 months
Secondary outcome [18] 0 0
SAP Cohort: Time in Target Range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) during Night for all subjects
Timepoint [18] 0 0
6 months
Secondary outcome [19] 0 0
SAP Cohort: Time in Target Range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) during Day and Night for all subjects
Timepoint [19] 0 0
6 months
Secondary outcome [20] 0 0
SAP Cohort: Time in Hypoglycemic Range during Day and Night for all subjects
Timepoint [20] 0 0
6 months
Secondary outcome [21] 0 0
SAP Cohort: Change in A1C for all subjects
Timepoint [21] 0 0
6 months

Eligibility
Key inclusion criteria
Inclusion Criteria

1. Subject is age 2-80 years at time of screening

1. US, Canada, Australia and New Zealand: Subjects 2-80 years of age will be allowed to enroll in the post approval study.
2. Europe: Only subjects =7 years of age are allowed to enroll in the post-market study.
2. Subjects who are 2-21 years are determined by the investigator to have the appropriate, requisite support (family, caregiver or social network) to successfully participate in this study
3. Subject must have a minimum daily insulin requirement (Total Daily Dose) of equal to or greater than 8 units/day
4. Subjects who are determined by the investigator to be psychologically sound in order to successfully participate in this study
5. Subject has been diagnosed with type 1 diabetes for at least three months Note: Determination of classification for diabetes will be based on American Diabetes Association Clinical Practice Guidelines accounting for several patient characteristics such as: age of onset, patient's weight or BMI, history of diabetic ketoacidosis, history of therapy management, if available in the medical records.
6. Subject must be on one of the following management therapies:

1. Multiple daily injections defined by use of rapid analogue with meals and approved long acting analogue (e.g. detemir or glargine) with or without CGM
2. Insulin pump therapy with or without CGM
7. Subject is willing to perform = 4 finger stick blood glucose measurements daily
8. Subject is willing to perform required study procedures
9. Subject is willing to wear the system continuously throughout the study for at least 80% of the time.
10. Subject is willing to upload data at least weekly from the study pump/meter, must have Internet access and a computer system that meets the requirements for uploading the study pump/meter for data collection
11. Subject must be willing to use the study glucose meter system (i.e. along with study meter strips).
12. If subject has celiac disease, it has been adequately treated as determined by the investigator
13. Subject with the diagnosis of myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack, cerebrovascular accident, angina, congestive heart failure, ventricular rhythm disturbances or thromboembolic disease, within 1 year of screening, will be included in the study with the consent of the Investigator
14. Subject is willing to take one of the following insulins and can financially afford to use either of the 2 insulin preparations throughout the course of the study (i.e. co-payments for insulin with insurance or able to pay full amount)

1. Humalog® (insulin lispro injection)
2. NovoLog® (insulin aspart)
Minimum age
2 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Subject participated in any Closed Loop study in the past.
2. Subject is unable to tolerate tape adhesive in the area of sensor placement
3. Subject has any unresolved adverse skin condition in the area of sensor placement (e.g., psoriasis, rash, Staphylococcus infection) or area of infusion set placement
4. Women of child-bearing potential who have a positive pregnancy test at screening or plan to become pregnant during the course of the study
5. Subject is being treated for hyperthyroidism at time of screening
6. Subject has an abnormality (out of reference range) in thyroid-stimulating hormone (TSH) at time of screening visit. TSH is not required for subjects 2-13 years of age.
7. Subject has taken any oral, injectable, or IV glucocorticoids within 8 weeks from time of screening visit, or plans to take any oral, injectable, or IV glucocorticoids during the course of the study.
8. Subject is actively participating in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or investigational study device in the last 2 weeks
9. Subject is currently abusing illicit drugs or marijuana
10. Subject is currently abusing prescription drugs
11. Subject is currently abusing alcohol
12. Subject is using pramlintide (Symlin), SGLT2 inhibitors, GLP agonists, biguanides, DPP-4 inhibitors or sulfonylureas at time of screening
13. Subject is using hydroxyurea at the time of screening or plans to use it during the study
14. Subject has a history of visual impairment which would not allow subject to participate in the study and perform all study procedures safely, as determined by the investigator
15. Subject has a sickle cell disease, hemoglobinopathy; or has received red blood cell transfusion or erythropoietin within 3 months prior to time of screening
16. Subject plans to receive red blood cell transfusion or erythropoietin over the course of study participation
17. Subject diagnosed with current moderate to severe eating disorder such as anorexia or bulimia
18. Subject has been diagnosed with chronic kidney disease requiring dialysis or resulting in chronic anemia
19. Subjects who are currently being actively treated for cancer.
20. Subject who is designated as a research staff member for this study

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/05/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2024
Actual
Sample size
Target
280
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Idaho
Country [7] 0 0
United States of America
State/province [7] 0 0
Indiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Iowa
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
State/province [10] 0 0
Minnesota
Country [11] 0 0
United States of America
State/province [11] 0 0
Missouri
Country [12] 0 0
United States of America
State/province [12] 0 0
New York
Country [13] 0 0
United States of America
State/province [13] 0 0
South Dakota
Country [14] 0 0
United States of America
State/province [14] 0 0
Texas
Country [15] 0 0
United States of America
State/province [15] 0 0
Washington
Country [16] 0 0
Canada
State/province [16] 0 0
British Columbia
Country [17] 0 0
Canada
State/province [17] 0 0
Ottawa
Country [18] 0 0
France
State/province [18] 0 0
Paris
Country [19] 0 0
France
State/province [19] 0 0
Pierre-Bénite
Country [20] 0 0
Germany
State/province [20] 0 0
Hannover
Country [21] 0 0
Italy
State/province [21] 0 0
Brescia
Country [22] 0 0
New Zealand
State/province [22] 0 0
Christchurch
Country [23] 0 0
New Zealand
State/province [23] 0 0
Dunedin
Country [24] 0 0
Spain
State/province [24] 0 0
Sevilla
Country [25] 0 0
Sweden
State/province [25] 0 0
Örebro
Country [26] 0 0
United Kingdom
State/province [26] 0 0
Cambridge

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Medtronic Diabetes
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate the safety and effectiveness of the Hybrid Closed Loop system (HCL) in adult and pediatric patients with type 1 diabetes in the home setting. A diverse population of patients with type 1 diabetes will be studied. The study population will have a large range for duration of diabetes and glycemic control, as measured by glycosylated hemoglobin (A1C). They will be enrolled in the study regardless of their prior diabetes regimen, including using Multiple Daily Injections (MDI), Continuous Subcutaneous Insulin Infusion (CSII) or Sensor-Augmented Pump therapy (SAP)
Trial website
https://clinicaltrials.gov/study/NCT02748018
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Thomas Troub
Address 0 0
Country 0 0
Phone 0 0
818-576-3142
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02748018