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

Not Applicable

Active, not recruiting

• Conditions: Type 1 Diabetes
• Interventions: Device: 670G and 770G Insulin Pump; Device: Subject's Current Diabetes Therapy

• Registration Number: NCT02748018
• Lead Sponsor: Medtronic Diabetes

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)

Detailed 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.

Study Timeline

• Study First Submitted: 2016-04-19
• Study First Submitted QC: 2016-04-21
• Study First Posted: 2016-04-22
• Study Start: 2017-05-25
• Status Verified: 2025-04
• Primary Completion: 2025-04
• Last Update Submitted: 2025-04-17
• Last Update Posted: 2025-04-20
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

Not provided

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hybrid Closed Loop Arm	670G and 770G Insulin Pump	The HCL Arm will use the MiniMed System (i.e., using Auto Mode) for 6 months during the study period.
Control Arm	Subject's Current Diabetes Therapy	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).

Primary Outcome Measures

Name	Time	Method
SAP Cohort: change of A1C (∆A1C) for subjects with baseline A1c > 8%	6 months	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%
CSII Cohort: Time in Hypoglycemic Range for subjects with baseline A1c ≤ 8%	6 months	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%
MDI Cohort: Time in Hypoglycemic Range for subjects with baseline A1c ≤ 8%	6 months	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%
CSII Cohort: change of A1C (∆A1C) for subjects with baseline A1c > 8%	6 months	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%
MDI Cohort: change of A1C (∆A1C) for subjects with baseline A1c > 8%	6 months	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%
SAP Cohort: Time in Hypoglycemic Range for subjects with baseline A1c ≤ 8%	6 months	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%

Secondary Outcome Measures

Name	Time	Method
SAP Cohort: Time in Target Range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) during Day and Night for all subjects	6 months	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
CSII Cohort: Time in Hypoglycemic Range during Night for all subjects	6 months	CSII Cohort: Time with SG below 70 mg/dL (3.9mmol/L) during Night for all subjects
CSII Cohort: Time in Hypoglycemic Range for subjects with baseline A1c > 8%	6 months	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%
MDI Cohort: Time in Hypoglycemic Range for subjects with baseline A1c > 8%	6 months	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%
MDI Cohort: Change in A1C (∆A1C) for subjects with baseline A1c ≤ 8%	6 months	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%
SAP Cohort: Time in Hypoglycemic Range for subjects with baseline A1c > 8%	6 months	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%
SAP Cohort: Time in Target Range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) during Night for all subjects	6 months	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
SAP Cohort: Change in A1C for all subjects	6 months	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
CSII Cohort: Change in A1C (∆A1C) for subjects with baseline A1c ≤ 8%	6 months	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%
CSII Cohort: Time in Target Range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) during Night for all subjects	6 months	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
SAP Cohort: Change in A1C (∆A1C) for subjects with baseline A1c ≤ 8%	6 months	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%
SAP Cohort: Time in Hypoglycemic Range during Day and Night for all subjects	6 months	SAP Cohort: Time with SG below 70 mg/dL (3.9mmol/L) during Day and Night for all subjects
CSII Cohort: Time in Hypoglycemic Range during Day and Night for all subjects	6 months	CSII Cohort: Time with SG below 70 mg/dL (3.9mmol/L) during Day and Night for all subjects
MDI Cohort: Time in Target Range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) during Night for all subjects	6 months	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
MDI Cohort: Time in Hypoglycemic Range during Day and Night for all subjects	6 months	MDI Cohort: Time with SG below 70 mg/dL (3.9mmol/L) during Day and Night for all subjects
SAP Cohort: Time in Hypoglycemic Range during Night for all subjects	6 months	SAP Cohort: Time with SG below 70 mg/dL (3.9mmol/L) during Night for all subjects
CSII Cohort: Time in Target Range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) during Day and Night for all subjects	6 months	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
CSII Cohort: Change in A1C for all subjects	6 months	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
MDI Cohort: Time in Hypoglycemic Range during Night for all subjects	6 months	MDI Cohort: Time with SG below 70 mg/dL (3.9mmol/L) during Night for all subjects
MDI Cohort: Change in A1C for all subjects	6 months	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
MDI Cohort: Time in Target Range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) during Day and Night for all subjects	6 months	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

Trial Locations

Locations (36)

Scripps Health System; 🇺🇸 La Jolla, California, United States

Stanford University; 🇺🇸 Palo Alto, California, United States

Center of Excellence in Diabetes & Endocrinology; 🇺🇸 Sacramento, California, United States

Sansum Diabetes Research Institute; 🇺🇸 Santa Barbara, California, United States

SoCal Diabetes; 🇺🇸 Torrance, California, United States

Diablo Clinical Research; 🇺🇸 Walnut Creek, California, United States

Barbara Davis Center; 🇺🇸 Aurora, Colorado, United States

University of South Florida Diabetes Center; 🇺🇸 Tampa, Florida, United States

Atlanta Diabetes Associates; 🇺🇸 Atlanta, Georgia, United States

Endocrine Research Solutions; 🇺🇸 Roswell, Georgia, United States

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