Multi-center Trial in Adult and Pediatric Patients With Type 1 Diabetes Using Hybrid Closed Loop System and Control at Home

Type 1 Diabetes Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02748018
• Other study ID #: CEP 304
• Status: Recruiting
• Phase: N/A
• Start date: May 25, 2017
• Est. completion date: September 2024

Study information

• Verified date: January 2024
• Source: Medtronic Diabetes
• Contact: Thomas Troub
• Phone: 818-576-3142
• Email: thomas.troub[@]medtronic.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Description:

This is a 6 month, multi-center, randomized, parallel, adaptive study in type 1 diabetes with a 6 month continuation period. The study will have three periods, per Cohort:

1. Run-in Period: The run-in period can be up to 60 days during which time a blinded CGM sensor will be worn for two weeks.

2. Study Period: There will be a 6 month randomized study period with two arms: The HCL system and Control.

3. Continuation Period: There will be a 6 month continuation period during which time all subjects will use the HCL system with Auto Mode.

Up to 1500 subjects will be enrolled in order to have 1000 subjects complete the study. Up to 70 investigational Centers in the US, Europe, Canada, Australia and New Zealand will be enrolled.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 280
• Est. completion date: September 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 80 Years

Eligibility

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)

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Device:
• 670G and 770G Insulin Pump
Medtronic 670G and 770G Hybrid Closed Loop Systems
• 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).

Locations

Country	Name	City	State
Canada	Westminster Endocrine & Diabetes Research Society	New Westminster	British Columbia
Canada	Children's Hospital of Eastern Ontario	Ottawa
France	Hôpital Necker Enfants Malades	Paris
France	HCL - Lyon Sud	Pierre-Bénite
Germany	Diabeteszentrum für Kinder und Jugendliche, Kinder- und Jugendkrankenhaus Auf der Bult	Hannover
Italy	A.S.S.T. Spedali Civili	Brescia
New Zealand	New Zealand Clinical Research	Christchurch
New Zealand	Dunedin Public Hospital	Dunedin
Spain	Hospital Universitario Virgen del Rocío	Sevilla
Sweden	Dept Internal Medicine, Örebro University Hospital	Örebro
United Kingdom	Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital	Cambridge
United States	University of Michigan	Ann Arbor	Michigan
United States	Atlanta Diabetes Associates	Atlanta	Georgia
United States	Barbara Davis Center	Aurora	Colorado
United States	Texas Diabetes & Endocrinology	Austin	Texas
United States	Grunberger Diabetes Institute	Bloomfield Hills	Michigan
United States	IDERC	Des Moines	Iowa
United States	Texas Children's Hospital / Baylor University	Houston	Texas
United States	Rocky Mountain Diabetes	Idaho Falls	Idaho
United States	Indiana University Health Riley Hospital for Children	Indianapolis	Indiana
United States	Scripps Health System	La Jolla	California
United States	Initernational Diabetes Center	Minneapolis	Minnesota
United States	International Diabetes Center	Minneapolis	Minnesota
United States	Yale School of Medicine	New Haven	Connecticut
United States	Stanford University	Palo Alto	California
United States	Rainier Clinical Research	Renton	Washington
United States	Mayo Clinic	Rochester	Minnesota
United States	Endocrine Research Solutions	Roswell	Georgia
United States	Center of Excellence in Diabetes & Endocrinology	Sacramento	California
United States	Washington University St. Louis	Saint Louis	Missouri
United States	Diabetes and Glandular Disease Clinic, P.A.	San Antonio	Texas
United States	Sansum Diabetes Research Institute	Santa Barbara	California
United States	University of Washington	Seattle	Washington
United States	Sanford Health	Sioux Falls	South Dakota
United States	SUNY Upstate Medical University	Syracuse	New York
United States	University of South Florida Diabetes Center	Tampa	Florida
United States	SoCal Diabetes	Torrance	California
United States	Diablo Clinical Research	Walnut Creek	California

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Diabetes

Countries where clinical trial is conducted

United States,  Canada,  France,  Germany,  Italy,  New Zealand,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CSII Cohort: change of A1C (?A1C) for subjects with baseline A1c > 8%	CSII Cohort: Change in A1C from baseline to the end of the six-month treatment period, defined as A1C measured at the six-month treatment visit minus A1C measured at the randomization visit. This is only for subjects with baseline A1c > 8%	6 months
Primary	CSII Cohort: Time in Hypoglycemic Range for subjects with baseline A1c = 8%	CSII Cohort: Time with sensor glucose (SG) below 70 mg/dL (3.9mmol/L) during the six-month study period. This is only for subjects with baseline A1c = 8%	6 months
Primary	MDI Cohort: change of A1C (?A1C) for subjects with baseline A1c > 8%	MDI Cohort: Change in A1C from baseline to the end of the six-month treatment period, defined as A1C measured at the six-month treatment visit minus A1C measured at the randomization visit. This is only for subjects with baseline A1c > 8%	6 months
Primary	MDI Cohort: Time in Hypoglycemic Range for subjects with baseline A1c = 8%	MDI Cohort: Time with sensor glucose (SG) below 70 mg/dL (3.9mmol/L) during the six-month study period. This is only for subjects with baseline A1c = 8%	6 months
Primary	SAP Cohort: change of A1C (?A1C) for subjects with baseline A1c > 8%	SAP Cohort: Change in A1C from baseline to the end of the six-month treatment period, defined as A1C measured at the six-month treatment visit minus A1C measured at the randomization visit. This is only for subjects with baseline A1c > 8%	6 months
Primary	SAP Cohort: Time in Hypoglycemic Range for subjects with baseline A1c = 8%	SAP Cohort: Time with sensor glucose (SG) below 70 mg/dL (3.9mmol/L) during the six-month study period. This is only for subjects with baseline A1c = 8%	6 months
Secondary	CSII Cohort: Time in Hypoglycemic Range for subjects with baseline A1c > 8%	CSII Cohort: Time with sensor glucose (SG) below 70 mg/dL (3.9mmol/L) during the six-month study period. This is only for subjects with baseline A1c > 8%	6 months
Secondary	CSII Cohort: Change in A1C (?A1C) for subjects with baseline A1c = 8%	CSII Cohort: Change in A1C from baseline to the end of the six-month treatment period, defined as A1C measured at the six-month treatment visit minus A1C measured at the randomization visit. This is only for subjects with baseline A1c = 8%	6 months
Secondary	CSII Cohort: Time in Hypoglycemic Range during Night for all subjects	CSII Cohort: Time with SG below 70 mg/dL (3.9mmol/L) during Night for all subjects	6 months
Secondary	CSII Cohort: Time in Target Range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) during Night for all subjects	CSII Cohort: Time in target range measures the time with SG in target range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) during Night for all subjects	6 months
Secondary	CSII Cohort: Time in Target Range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) during Day and Night for all subjects	CSII Cohort: Time in target range measures the time with SG in target range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) during Day and Night for all subjects	6 months
Secondary	CSII Cohort: Time in Hypoglycemic Range during Day and Night for all subjects	CSII Cohort: Time with SG below 70 mg/dL (3.9mmol/L) during Day and Night for all subjects	6 months
Secondary	CSII Cohort: Change in A1C for all subjects	CSII Cohort: Change in A1C from baseline to the end of the six-month treatment period, defined as A1C measured at the six-month treatment visit minus A1C measured at the randomization visit for all subjects	6 months
Secondary	MDI Cohort: Time in Hypoglycemic Range for subjects with baseline A1c > 8%	MDI Cohort: Time with sensor glucose (SG) below 70 mg/dL (3.9mmol/L) during the six-month study period. This is only for subjects with baseline A1c > 8%	6 months
Secondary	MDI Cohort: Change in A1C (?A1C) for subjects with baseline A1c = 8%	MDI Cohort: Change in A1C from baseline to the end of the six-month treatment period, defined as A1C measured at the six-month treatment visit minus A1C measured at the randomization visit. This is only for subjects with baseline A1c = 8%	6 months
Secondary	MDI Cohort: Time in Hypoglycemic Range during Night for all subjects	MDI Cohort: Time with SG below 70 mg/dL (3.9mmol/L) during Night for all subjects	6 months
Secondary	MDI Cohort: Time in Target Range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) during Night for all subjects	MDI Cohort: Time in target range measures the time with SG in target range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) during Night for all subjects	6 months
Secondary	MDI Cohort: Time in Target Range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) during Day and Night for all subjects	MDI Cohort: Time in target range measures the time with SG in target range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) during Day and Night for all subjects	6 months
Secondary	MDI Cohort: Time in Hypoglycemic Range during Day and Night for all subjects	MDI Cohort: Time with SG below 70 mg/dL (3.9mmol/L) during Day and Night for all subjects	6 months
Secondary	MDI Cohort: Change in A1C for all subjects	MDI Cohort: Change in A1C from baseline to the end of the six-month treatment period, defined as A1C measured at the six-month treatment visit minus A1C measured at the randomization visit for all subjects	6 months
Secondary	SAP Cohort: Time in Hypoglycemic Range for subjects with baseline A1c > 8%	SAP Cohort: Time with sensor glucose (SG) below 70 mg/dL (3.9mmol/L) during the six-month study period. This is only for subjects with baseline A1c > 8%	6 months
Secondary	SAP Cohort: Change in A1C (?A1C) for subjects with baseline A1c = 8%	SAP Cohort: Change in A1C from baseline to the end of the six-month treatment period, defined as A1C measured at the six-month treatment visit minus A1C measured at the randomization visit. This is only for subjects with baseline A1c = 8%	6 months
Secondary	SAP Cohort: Time in Hypoglycemic Range during Night for all subjects	SAP Cohort: Time with SG below 70 mg/dL (3.9mmol/L) during Night for all subjects	6 months
Secondary	SAP Cohort: Time in Target Range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) during Night for all subjects	SAP Cohort: Time in target range measures the time with SG in target range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) during Night for all subjects	6 months
Secondary	SAP Cohort: Time in Target Range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) during Day and Night for all subjects	SAP Cohort: Time in target range measures the time with SG in target range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) during Day and Night for all subjects	6 months
Secondary	SAP Cohort: Time in Hypoglycemic Range during Day and Night for all subjects	SAP Cohort: Time with SG below 70 mg/dL (3.9mmol/L) during Day and Night for all subjects	6 months
Secondary	SAP Cohort: Change in A1C for all subjects	SAP Cohort: Change in A1C from baseline to the end of the six-month treatment period, defined as A1C measured at the six-month treatment visit minus A1C measured at the randomization visit for all subjects	6 months