Type 1 DiabetesNCT02748018
Multi-center Trial in Adult and Pediatric Patients With Type 1 Diabetes Using Hybrid Closed Loop System and Control at Home
A study testing 670G and 770G Insulin Pump and Subject's Current Diabetes Therapy in people with Type 1 Diabetes, run by Medtronic MiniMed, Inc. at 36 sites in 9 countries.
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. Read more about this study
- Who is it for?
- Ages 2 to 80 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- 670G and 770G Insulin Pump and Subject's Current Diabetes Therapy
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 959 participants
- Where
- 36 sitesin 9 countries
- Study dates
- 25 May 2017to 1 Nov 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subject is age 2-80 years at time of screening
- US, Canada, Australia and New Zealand: Subjects 2-80 years of age will be allowed to enroll in the post approval study.
- Europe: Only subjects ≥7 years of age are allowed to enroll in the post-market study.
- 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
- Subject must have a minimum daily insulin requirement (Total Daily Dose) of equal to or greater than 8 units/day
- Subjects who are determined by the investigator to be psychologically sound in order to successfully participate in this study
Show all 20Show fewer
- 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.
- Subject must be on one of the following management therapies:
- 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
- Insulin pump therapy with or without CGM
- Subject is willing to perform ≥ 4 finger stick blood glucose measurements daily
- Subject is willing to perform required study procedures
- Subject is willing to wear the system continuously throughout the study for at least 80% of the time.
- 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
- Subject must be willing to use the study glucose meter system (i.e. along with study meter strips).
- If subject has celiac disease, it has been adequately treated as determined by the investigator
- 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
- 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)
- Humalog® (insulin lispro injection)
- NovoLog® (insulin aspart)
Who cannot join
- Subject participated in any Closed Loop study in the past.
- 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 placement (e.g., psoriasis, rash, Staphylococcus infection) or area of infusion set placement
- Women of child-bearing potential who have a positive pregnancy test at screening or plan to become pregnant during the course of the study
- Subject is being treated for hyperthyroidism at time of screening
- 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.
Show all 20Show fewer
- 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.
- 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
- Subject is currently abusing illicit drugs or marijuana
- Subject is currently abusing prescription drugs
- Subject is currently abusing alcohol
- Subject is using pramlintide (Symlin), SGLT2 inhibitors, GLP agonists, biguanides, DPP-4 inhibitors or sulfonylureas at time of screening
- Subject is using hydroxyurea at the time of screening or plans to use it during the study
- 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
- Subject has a sickle cell disease, hemoglobinopathy; or has received red blood cell transfusion or erythropoietin within 3 months prior to time of screening
- Subject plans to receive red blood cell transfusion or erythropoietin over the course of study participation
- Subject diagnosed with current moderate to severe eating disorder such as anorexia or bulimia
- Subject has been diagnosed with chronic kidney disease requiring dialysis or resulting in chronic anemia
- Subjects who are currently being actively treated for cancer.
- Subject who is designated as a research staff member for this study
Trial locations and contacts
36 sites in 9 countries.
36 sites in 9 countries
United States25 sites
University of Michigan
Ann Arbor, Michigan, 48109
Atlanta Diabetes Associates
Atlanta, Georgia, 30318
Barbara Davis Center
Aurora, Colorado, 80045
Texas Diabetes & Endocrinology
Austin, Texas, 78731
Grunberger Diabetes Institute
Bloomfield Hills, Michigan, 48302
IDERC
Des Moines, Iowa, 50265
Rocky Mountain Diabetes
Idaho Falls, Idaho, 93404
Indiana University Health Riley Hospital for Children
Indianapolis, Indiana, 46202
Scripps Health System
La Jolla, California, 92037
Initernational Diabetes Center
Minneapolis, Minnesota, 55416
International Diabetes Center
Minneapolis, Minnesota, 55416
Stanford University
Palo Alto, California, 94304
Rainier Clinical Research
Renton, Washington, 98057
Mayo Clinic
Rochester, Minnesota, 55905
Endocrine Research Solutions
Roswell, Georgia, 30076
Center of Excellence in Diabetes & Endocrinology
Sacramento, California, 95821
Diabetes and Glandular Disease Clinic, P.A.
San Antonio, Texas, 78229
Sansum Diabetes Research Institute
Santa Barbara, California, 93105
University of Washington
Seattle, Washington, 98105
Sanford Health
Sioux Falls, South Dakota, 57104
Washington University St. Louis
St Louis, Missouri, 63110
SUNY Upstate Medical University
Syracuse, New York, 13210
University of South Florida Diabetes Center
Tampa, Florida, 33612
SoCal Diabetes
Torrance, California, 90505
Diablo Clinical Research
Walnut Creek, California, 94598
Canada2 sites
Westminster Endocrine & Diabetes Research Society
New Westminster, British Columbia, V3L 3W5
Children's Hospital of Eastern Ontario
Ottawa, K1H 8L1
France2 sites
Hôpital Necker Enfants Malades
Paris, 75015
HCL - Lyon Sud
Pierre-Bénite, 69495
New Zealand2 sites
New Zealand Clinical Research
Christchurch, 8011
Dunedin Public Hospital
Dunedin, 9016
Germany1 site
Diabeteszentrum für Kinder und Jugendliche, Kinder- und Jugendkrankenhaus Auf der Bult
Hanover, 30173
Sweden1 site
Dept Internal Medicine, Örebro University Hospital
Örebro, SE-70185
United Kingdom1 site
Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital
Cambridge
About this study
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
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)
Read the 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:
- 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.
- Study Period: There will be a 6 month randomized study period with two arms: The HCL system and Control. The primary and secondary endpoints will be evaluated during this period only.
- Continuation Period: There will be a 6 month continuation period during which time all subjects will use the HCL system with Auto Mode. Only the safety endpoint will be evaluated during this period.
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.
- Conditions
- Type 1 Diabetes
- Being tested
- 670G and 770G Insulin Pump, Subject's Current Diabetes Therapy
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
670G and 770G Insulin PumpDevice
Medtronic 670G and 770G Hybrid Closed Loop Systems
Subject's Current Diabetes TherapyDevice
Subject will use current diabetes therapy: CSII (Continuous Subcutaneous Insulin Infusion), MDI (Multiple Daily Injections) or SAP (Sensor Augmented Pump).
| Study group | Role | What they receive |
|---|---|---|
| Hybrid Closed Loop Arm | Experimental | The HCL Arm will use the MiniMed System (i.e., using Auto Mode) for 6 months during the study period. Receives: Device: 670G and 770G Insulin Pump |
| Control Arm | Active comparator | 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). Receives: Device: Subject's Current Diabetes Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
CSII Cohort: Baseline A1C > 8%: Change in A1C (∆A1C)
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 subjects with baseline A1C > 8%
Measured: Baseline and end of 6-month study period
CSII Cohort: Baseline A1C ≤ 8%: Time in Hypoglycemic Range
CSII Cohort: Time with sensor glucose (SG) below 70 mg/dL (3.9mmol/L) during the six-month study period, for subjects with baseline A1c ≤ 8%
Measured: 6 months study period
MDI Cohort: Baseline A1C > 8%: Change of A1C (∆A1C)
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 subjects with baseline A1c > 8%
Measured: Baseline and end of 6-month study period
MDI Cohort: Baseline A1C ≤ 8%: Time in Hypoglycemic Range
MDI Cohort: Time with sensor glucose (SG) below 70 mg/dL (3.9mmol/L) during the six-month study period, for subjects with baseline A1c ≤ 8%
Measured: 6 months study period
SAP Cohort: Baseline A1C > 8%: Change of A1C (∆A1C)
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 subjects with baseline A1c > 8%
Measured: Baseline and end of 6-month study period
SAP Cohort: Baseline A1C ≤ 8%: Time in Hypoglycemic Range
SAP Cohort: Time with sensor glucose (SG) below 70 mg/dL (3.9mmol/L) during the six-month study period, for subjects with baseline A1c ≤ 8%
Measured: 6 months study period
Secondary outcomes (21)
CSII Cohort: Baseline A1C > 8%: Time in Hypoglycemic Range
CSII Cohort: Time with sensor glucose (SG) below 70 mg/dL (3.9mmol/L) during the six-month study period, for subjects with baseline A1c > 8%
Measured: 6 months study period
CSII Cohort: Baseline A1C ≤ 8%: Change in A1C (∆A1C)
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 subjects with baseline A1c ≤ 8%
Measured: Baseline and end of 6-month study period
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
Measured: 6 months study period
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
Measured: 6 months study period
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
Measured: 6 months study period
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
Measured: 6 months study period
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
Measured: Baseline and end of 6-month study period
MDI Cohort: Baseline A1C > 8%: Time in Hypoglycemic Range
MDI Cohort: Time with sensor glucose (SG) below 70 mg/dL (3.9mmol/L) during the six-month study period, for subjects with baseline A1c > 8%
Measured: 6 months study period
MDI Cohort: Baseline A1C ≤ 8%: Change in A1C (∆A1C)
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 subjects with baseline A1c ≤ 8%
Measured: Baseline and end of 6-month study period
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
Measured: 6 months study period
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
Measured: 6 months study period
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
Measured: 6 months study period
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
Measured: 6 months study period
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
Measured: Baseline and end of 6-month study period
SAP Cohort: Baseline A1C > 8%: Time in Hypoglycemic Range
SAP Cohort: Time with sensor glucose (SG) below 70 mg/dL (3.9mmol/L) during the six-month study period, for subjects with baseline A1c > 8%
Measured: 6 months study period
SAP Cohort: Baseline A1C ≤ 8%: Change in A1C (∆A1C)
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 subjects with baseline A1c ≤ 8%
Measured: Baseline and end of 6-month study period
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
Measured: 6 months study period
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
Measured: 6 months study period
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
Measured: 6 months study period
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
Measured: 6 months study period
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
Measured: Baseline and end of 6-month study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2016 (estimated)
- Study start25 May 2017
- Primary completion1 Nov 2023
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There will be three cohorts sequentially enrolled for the study. Cohort 1: Continuous Subcutaneous Insulin Infusion (CSII cohort): randomized to HCL (treatment arm) or CSII (Control arm) Cohort 2: Multiple Daily Injections (MDI cohort): randomized to HCL (treatment arm) or MDI (Control arm) Cohort 3: Sensor-Augmented Pump therapy (SAP cohort): randomized to HCL (treatment arm) or SAP (Control arm) Note: Subjects 2-6 years of age will automatically enter the HCL arm at the end of the run-in period
- Masking
- None (open label)
- Enrolment
- 959 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic MiniMed, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02748018
- Sponsor's protocol ID
- CEP 304
- Status last verified
- Jul 2025
- First submitted
- 19 Apr 2016
- Last updated
- 19 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Jendle JH, Garg SK, Thivolet C, Weinstock RS, Hirsch IB, Evans M, Griffin KJ, Philis-Tsimikas A, Wheeler BJ, Kipnes MS, Carlson AL, Buckingham BA, Bhargava A, Bode BW, Lawson ML, Criego AB, McGill JB, Reed JCH, Prakasam G, Grunberger G, Girelli A, Martinez-Brocca MA, Christiansen MP, de Bock MI, Kudva YC, Lee SW, Yovanovich C, Shin JJ, Cordero TL, McVean JJF, Vigersky RA. Automated basal insulin delivery versus multiple daily injections in type 1 diabetes: results from a randomized parallel controlled trial. Front Endocrinol (Lausanne). 2025 Dec 19;16:1716587. doi: 10.3389/fendo.2025.1716587. eCollection 2025.
PubMed 41488135
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02748018
- Acronym / sponsor ID
- CEP 304
- Conditions
- Type 1 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 959 participants (actual)
- Lead sponsor
- Medtronic MiniMed, Inc.Industry (pharma, biotech, devices)
- Study start
- 25 May 2017 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 22 Apr 2016 (estimated)
- Results
- Posted 19 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- Study Period: There will be a 6 month randomized study period with two arms: The HCL system and Control. The primary and secondary endpoints will be evaluated during this period only.
- Continuation Period: There will be a 6 month continuation period during which time all subjects will use the HCL system with Auto Mode. Only the safety endpoint will be evaluated during this period.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- There will be three cohorts sequentially enrolled for the study. Cohort 1: Continuous Subcutaneous Insulin Infusion (CSII cohort): randomized to HCL (treatment arm) or CSII (Control arm) Cohort 2: Multiple Daily Injections (MDI cohort): randomized to HCL (treatment arm) or MDI (Control arm) Cohort 3: Sensor-Augmented Pump therapy (SAP cohort): randomized to HCL (treatment arm) or SAP (Control arm) Note: Subjects 2-6 years of age will automatically enter the HCL arm at the end of the run-in period
| Arm | Type | Receives |
|---|---|---|
| Hybrid Closed Loop Arm | Experimental | Device: 670G and 770G Insulin PumpThe HCL Arm will use the MiniMed System (i.e., using Auto Mode) for 6 months during the study period. |
| Control Arm | Active comparator | Device: Subject's Current Diabetes TherapyThe 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). |
Who may qualify
- Ages
- 2 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (20 listed)
- Subject is age 2-80 years at time of screening
- 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
- Subject must have a minimum daily insulin requirement (Total Daily Dose) of equal to or greater than 8 units/day
- Subjects who are determined by the investigator to be psychologically sound in order to successfully participate in this study
- 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.
Key exclusion criteria (20 listed)
- Subject participated in any Closed Loop study in the past.
- 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 placement (e.g., psoriasis, rash, Staphylococcus infection) or area of infusion set placement
- Women of child-bearing potential who have a positive pregnancy test at screening or plan to become pregnant during the course of the study
- Subject is being treated for hyperthyroidism at time of screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 670G and 770G Insulin PumpMedtronic 670G and 770G Hybrid Closed Loop Systems | Device | Hybrid Closed Loop Arm |
| Subject's Current Diabetes TherapySubject will use current diabetes therapy: CSII (Continuous Subcutaneous Insulin Infusion), MDI (Multiple Daily Injections) or SAP (Sensor Augmented Pump). | Device | Control Arm |
Primary outcome
CSII Cohort: Baseline A1C > 8%: Change in A1C (∆A1C)
Time frame: Baseline and end of 6-month study period
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 subjects with baseline A1C > 8%
CSII Cohort: Baseline A1C ≤ 8%: Time in Hypoglycemic Range
Time frame: 6 months study period
CSII Cohort: Time with sensor glucose (SG) below 70 mg/dL (3.9mmol/L) during the six-month study period, for subjects with baseline A1c ≤ 8%
MDI Cohort: Baseline A1C > 8%: Change of A1C (∆A1C)
Time frame: Baseline and end of 6-month study period
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 subjects with baseline A1c > 8%
MDI Cohort: Baseline A1C ≤ 8%: Time in Hypoglycemic Range
Time frame: 6 months study period
MDI Cohort: Time with sensor glucose (SG) below 70 mg/dL (3.9mmol/L) during the six-month study period, for subjects with baseline A1c ≤ 8%
SAP Cohort: Baseline A1C > 8%: Change of A1C (∆A1C)
Time frame: Baseline and end of 6-month study period
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 subjects with baseline A1c > 8%
SAP Cohort: Baseline A1C ≤ 8%: Time in Hypoglycemic Range
Time frame: 6 months study period
SAP Cohort: Time with sensor glucose (SG) below 70 mg/dL (3.9mmol/L) during the six-month study period, for subjects with baseline A1c ≤ 8%
21 secondary outcomes
CSII Cohort: Baseline A1C > 8%: Time in Hypoglycemic Range
Time frame: 6 months study period
CSII Cohort: Baseline A1C ≤ 8%: Change in A1C (∆A1C)
Time frame: Baseline and end of 6-month study period
CSII Cohort: Time in Hypoglycemic Range During Night for All Subjects
Time frame: 6 months study period
CSII Cohort: Time in Target Range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) During Night for All Subjects
Time frame: 6 months study period
CSII Cohort: Time in Target Range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) During Day and Night for All Subjects
Time frame: 6 months study period
CSII Cohort: Time in Hypoglycemic Range During Day and Night for All Subjects
Time frame: 6 months study period
CSII Cohort: Change in A1C for All Subjects
Time frame: Baseline and end of 6-month study period
MDI Cohort: Baseline A1C > 8%: Time in Hypoglycemic Range
Time frame: 6 months study period
MDI Cohort: Baseline A1C ≤ 8%: Change in A1C (∆A1C)
Time frame: Baseline and end of 6-month study period
MDI Cohort: Time in Hypoglycemic Range During Night for All Subjects
Time frame: 6 months study period
MDI Cohort: Time in Target Range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) During Night for All Subjects
Time frame: 6 months study period
MDI Cohort: Time in Target Range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) During Day and Night for All Subjects
Time frame: 6 months study period
MDI Cohort: Time in Hypoglycemic Range During Day and Night for All Subjects
Time frame: 6 months study period
MDI Cohort: Change in A1C for All Subjects
Time frame: Baseline and end of 6-month study period
SAP Cohort: Baseline A1C > 8%: Time in Hypoglycemic Range
Time frame: 6 months study period
SAP Cohort: Baseline A1C ≤ 8%: Change in A1C (∆A1C)
Time frame: Baseline and end of 6-month study period
SAP Cohort: Time in Hypoglycemic Range During Night for All Subjects
Time frame: 6 months study period
SAP Cohort: Time in Target Range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) During Night for All Subjects
Time frame: 6 months study period
SAP Cohort: Time in Target Range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) During Day and Night for All Subjects
Time frame: 6 months study period
SAP Cohort: Time in Hypoglycemic Range During Day and Night for All Subjects
Time frame: 6 months study period
SAP Cohort: Change in A1C for All Subjects
Time frame: Baseline and end of 6-month study period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41488135Jendle JH, Garg SK, Thivolet C, Weinstock RS, Hirsch IB, Evans M, Griffin KJ, Philis-Tsimikas A, Wheeler BJ, Kipnes MS, Carlson AL, Buckingham BA, Bhargava A, Bode BW, Lawson ML, Criego AB, McGill JB, Reed JCH, Prakasam G, Grunberger G, Girelli A, Martinez-Brocca MA, Christiansen MP, de Bock MI, Kudva YC, Lee SW, Yovanovich C, Shin JJ, Cordero TL, McVean JJF, Vigersky RA. Automated basal insulin delivery versus multiple daily injections in type 1 diabetes: results from a randomized parallel controlled trial. Front Endocrinol (Lausanne). 2025 Dec 19;16:1716587. doi: 10.3389/fendo.2025.1716587. eCollection 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
36 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 670G and 770G Insulin Pump and Subject's Current Diabetes Therapy in people with Type 1 Diabetes, run by Medtronic MiniMed, Inc. at 36 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in United States, Canada, France, New Zealand, Germany and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CSII Cohort: Baseline A1C > 8%: Change in A1C (∆A1C) (time frame: Baseline and end of 6-month study period). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02748018, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2025.