Safety Evaluation of the Hybrid Closed Loop (HCL) System in Pediatric Subjects With Type 1 Diabetes

A study testing Insulin Pump in people with Type 1 Diabetes, run by Medtronic MiniMed, Inc. at 11 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study is a single-arm, multi-center, Home and Hotel Clinical Investigation in pediatric subjects with type 1 diabetes on insulin pump therapy. The purpose of this study is to demonstrate that the closed loop algorithm is safe as part of the overall system, and to assess the PLGM feature in 7-13 years old subjects. Read more about this study

Who is it for?: Ages 2 to 13 years
Conditions the study is for: Type 1 Diabetes
What is being tested?: Insulin Pump
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 151 participants
Where: 11 sitesin 2 countries
Study dates: 18 Apr 2016to 1 Feb 2021
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 13 years
All sexes
No healthy volunteers
Child

Who may be able to join

General Inclusion Criteria
Subject is age 2-13 years at time of screening
Subject has a clinical diagnosis of type 1 diabetes for 1 year or more as determined via medical record or source documentation by an individual qualified to make a medical diagnosis
Subject age 2-6 years has a clinical diagnosis of type 1 diabetes for 3 months or more as determined via medical record or source documentation by an individual qualified to make a medical diagnosis
Study-specific inclusion criteria
Subject must have a minimum daily insulin requirement (Total Daily Dose) of greater than or equal to 8 units

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Subjects 7-13: Subjects and their parent(s)/guardian(s) are willing to participate in an overnight visit at the end of the run-in period.
Subject 7-13 years of age and their parent(s)/guardian(s) are willing to participate in a hotel study for the specified duration of hotel stay.
Subject 2-6 years of age and their parent(s)/guardian(s) are willing to participate in an extended visit during the study period to perform Frequent Sample Testing.
Subject must have companion 18 years or older who will sleep in the same dwelling place every night during the study period. This requirement may be verified by subject report at screening visit.
Subject is willing to perform ≥ 4 finger stick blood glucose measurements daily
Subject is willing to perform required sensor calibrations
Subject is willing to wear the system continuously throughout the study
Subject has a Glycosylated hemoglobin (A1C) value less than 10.0% (as processed by Central Lab) at time of screening visit Note: All HbA1C blood specimens will be sent to and tested by a NGSP certified Central Laboratory. A1C testing must follow National Glycohemoglobin Standardization Program (NGSP) standards.
Subject has TSH in the normal range OR if the TSH is out of normal reference range the Free T3 is below or within the lab's reference range and Free T4 is within the normal reference range.
Subject 7 -13 years of age has had pump therapy for greater than 6 months prior to screening (with or without CGM experience)
Subject 2-6 years of age has had pump therapy for greater than 90 days prior to screening (with or without CGM experience)
Subjects and their parent(s)/guardian(s) are willing to upload data from the study pump; must have Internet access and a computer system that meets the requirements for uploading the study pump
If subject has celiac disease, it has been adequately treated as determined by the investigator
Subjects and their parent(s)/guardian(s) are willing to take one of the following insulins and can financially support the use of 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)
Subjects and their parent(s)/guardian(s)/companions must be able to speak and be literate in English as verified by the investigator

Who cannot join

Subject has a history of 2 or more episodes of severe hypoglycemia, which resulted in any the following during the 6 months prior to screening:
Medical assistance (i.e. Paramedics, Emergency Room ( ER) or Hospitalization)
Coma
Seizures
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, dermatitis herpetiformis, rash, Staphylococcus infection)

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Females who are sexually active and able to conceive will be excluded if they are not using an effective method of contraception and do not agree to continue using an effective method of contraception for the duration of the study as determined by investigator.
Subject has a cardiovascular condition which the investigator determines should exclude the subject, i.e. ventricular rhythm disturbance, hypertrophic cardiomyopathy
Subject is being treated for hyperthyroidism at time of screening
Subject has diagnosis of adrenal insufficiency
Subject 7-13 years of age has had DKA in the 6 months prior to screening visit.
Subject 2-6 years of age has had DKA in the 3 months prior to screening visit
Subject has taken any oral, injectable, or intravenous (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 7-13 years of age has been hospitalized or has visited the ER in the 6 months prior to screening resulting in a primary diagnosis of uncontrolled diabetes
Subject 2-6 years of age has been hospitalized or has visited the ER in the 3 months prior to screening resulting in a primary diagnosis of uncontrolled diabetes
Subject is currently abusing illicit drugs
Subject is currently abusing marijuana.
Subject is currently abusing prescription drugs
Subject is currently abusing alcohol
Subject is using pramlintide (Symlin), DPP-4 inhibitor, liraglutide (Victoza or other GLP-1 agonists), metformin, canagliflozin (Invokana or other SGLT2 inhibitors) at time of screening
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 elective surgery planned that requires general anesthesia during the course of the study
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 eating disorder such as anorexia or bulimia
Subject has been diagnosed with chronic kidney disease that results in chronic anemia
Subject has a hematocrit that is below the normal reference range of lab used.
Subject is on dialysis
Subject has serum creatinine of >2 mg/dL.

Trial locations and contacts

11 sites in 2 countries.

Country

City, postcode or hospital

11 sites in 2 countries

United States10 sites

University of Michigan
Ann Arbor, Michigan, 48109
Atlanta Diabetes Associates
Atlanta, Georgia, 30318
Barbara Davis Center
Aurora, Colorado, 80045
AMCR Institute
Escondido, California, 92025
Rocky Mountain Diabetes and Osteoporosis Center
Idaho Falls, Idaho, 83404
Indiana University
Indianapolis, Indiana, 46202
Nemours Children's Clinic
Jacksonville, Florida, 32207
Stanford Hospital and Clinics
Palo Alto, California, 94305
University of South Florida - USF Health
Tampa, Florida, 33620
SoCal Diabetes
Torrance, California, 90505

Other trials in United States

Israel1 site

Sheba Medical Center
Tel Aviv

Other trials in Israel

About this study

Read the detailed description

The study will proceed as follows:

Run-in Period - General:

A total of up to 200 subjects (age 2-13) will be enrolled at up to 15 investigational centers (14 in the US, 1 EMEA) in order to reach 120 subjects who will complete the HCL study.

Study Period - At Home:

Following the two week run-in period using the Study Pump (670G), all subjects (age 2-13) will participate in a 3-month study period.

Study Period - Hotel Study Subjects (age 7-13) will participate in a Hotel study (6 days, 5 nights), with the remainder of the study period to be spent at home. Subjects 2-6 years of age are not required to participate in a hotel study. Instead, they will participate in an out-of-home study for 5 consecutive days, 4-6 hours per day.

Continued Access Program Subjects will be given the opportunity to extend use of their study devices for a period of up to 3 years . If subjects choose to participate in the continuation period, they will retain the study devices at the end of study period visit or receive them back in the event they have been returned to study staff already.

Conditions: Type 1 Diabetes
Being tested: Insulin Pump
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.

Insulin PumpDevice
Also called MMT-670G
Closed Loop Algorithm

Study groups in NCT02660827
Study group	Role	What they receive
Hybrid closed loop	Experimental	All subjects will be wearing the MMT-670G insulin pump, using it with the closed loop algorithm Receives: Device: Insulin Pump

What is being measured

The primary outcome is the main question the study is designed to answer.

Age 2-13 Years Old Subjects Change in A1C
Descriptive analysis of change in A1C from baseline to end of 3-month study period
Measured: Baseline and end of 3-month study period

Secondary outcomes (6)

Age 2-13 Years Old Subjects Mean Change in % of Time in Euglycemia (70-180 mg/dL)
mean change in % of time in Euglycemia (70-180 mg/dL) from baseline to 3 months study period
Measured: baseline and 3 months
Age 2-13 Years Old Subjects Mean Change in % of Time in Hyperglycemia (> 180 mg/dL)
mean change in % of time in hyperglycemia (> 180 mg/dL) from baseline to 3 months study period
Measured: baseline and 3 months
Age 2-13 Years Old Subjects Mean Change in % of Time in Hypoglycemia (<70 mg/dL)
mean change in % of time in hypoglycemia (< 70 mg/dL) from baseline to 3 months study period
Measured: baseline and 3 months
Age 2-13 Years Old - Number of Severe Hypoglycemic Event
Number of severe hypoglycemic events occurred during 3-month study period.
Measured: 3 months
Age 2-13 Years Old - Number of Diabetic Ketoacidosis (DKA) Event
Number of Diabetic Ketoacidosis (DKA) events occurred during 3-month study period.
Measured: 3 months
Age 7-13 Years Old Subjects PLGM Performance - Event Rate Without Hypoglycemia at YSI-FST <=65 mg/dL
Event rate without Hypoglycemia at YSI-FST <=65 mg/dL among 105 subjects who underwent the PLGM experiments. The event rate without hypoglycemia is the number of experiments without hypoglycemia/total number of experiments and hypoglycemic events are defined based on the occurrence of 2 or more continuous YSI-FST <= 65mg/dL during in-clinic procedures.
Measured: Up to 12 hours after the start of PLGM period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Apr 20161 Feb 2021

First posted21 Jan 2016 (estimated)
Study start18 Apr 2016
Primary completion28 Nov 2018
Study completion1 Feb 2021

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 (2)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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 151 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02660827
Sponsor's protocol ID: CEP 302
Status last verified: Jan 2022
First submitted: 16 Jan 2016
Last updated: 26 Jan 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Publications

Forlenza GP, Ekhlaspour L, DiMeglio LA, Fox LA, Rodriguez H, Shulman DI, Kaiserman KB, Liljenquist DR, Shin J, Lee SW, Buckingham BA. Glycemic outcomes of children 2-6 years of age with type 1 diabetes during the pediatric MiniMed 670G system trial. Pediatr Diabetes. 2022 May;23(3):324-329. doi: 10.1111/pedi.13312. Epub 2022 Jan 31.
PubMed 35001477
Forlenza GP, Pinhas-Hamiel O, Liljenquist DR, Shulman DI, Bailey TS, Bode BW, Wood MA, Buckingham BA, Kaiserman KB, Shin J, Huang S, Lee SW, Kaufman FR. Safety Evaluation of the MiniMed 670G System in Children 7-13 Years of Age with Type 1 Diabetes. Diabetes Technol Ther. 2019 Jan;21(1):11-19. doi: 10.1089/dia.2018.0264. Epub 2018 Dec 26.
PubMed 30585770

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 26 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety Evaluation of the Hybrid Closed Loop (HCL) System in Pediatric Subjects With Type 1 Diabetes
ClinicalTrials.gov ID: NCT02660827
Acronym / sponsor ID: CEP 302
Conditions: Type 1 Diabetes
Study type: Interventional
Recruitment status: Completed
Enrolment: 151 participants (actual)
Lead sponsor: Medtronic MiniMed, Inc.Industry (pharma, biotech, devices)
Study start: 18 Apr 2016 (actual)
Primary completion: 28 Nov 2018 (actual)
Study completion: 1 Feb 2021 (actual)
First posted: 21 Jan 2016 (estimated)
Results: Posted 11 Jan 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The study will proceed as follows:

Run-in Period - General:

A total of up to 200 subjects (age 2-13) will be enrolled at up to 15 investigational centers (14 in the US, 1 EMEA) in order to reach 120 subjects who will complete the HCL study.

Study Period - At Home:

Following the two week run-in period using the Study Pump (670G), all subjects (age 2-13) will participate in a 3-month study period.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Hybrid closed loop	Experimental	Device: Insulin PumpAll subjects will be wearing the MMT-670G insulin pump, using it with the closed loop algorithm

Who may qualify

Ages: 2 to 13 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (23 listed)

General Inclusion Criteria
Subject is age 2-13 years at time of screening
Subject has a clinical diagnosis of type 1 diabetes for 1 year or more as determined via medical record or source documentation by an individual qualified to make a medical diagnosis
Subject age 2-6 years has a clinical diagnosis of type 1 diabetes for 3 months or more as determined via medical record or source documentation by an individual qualified to make a medical diagnosis
Study-specific inclusion criteria

Key exclusion criteria (30 listed)

Subject has a history of 2 or more episodes of severe hypoglycemia, which resulted in any the following during the 6 months prior to screening:
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, dermatitis herpetiformis, rash, Staphylococcus infection)
Females who are sexually active and able to conceive will be excluded if they are not using an effective method of contraception and do not agree to continue using an effective method of contraception for the duration of the study as determined by investigator.
Subject has a cardiovascular condition which the investigator determines should exclude the subject, i.e. ventricular rhythm disturbance, hypertrophic cardiomyopathy

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
Insulin PumpAlso: MMT-670GClosed Loop Algorithm	Device	Hybrid closed loop

Primary outcome

Age 2-13 Years Old Subjects Change in A1C
Time frame: Baseline and end of 3-month study period
Descriptive analysis of change in A1C from baseline to end of 3-month study period

6 secondary outcomes

Age 2-13 Years Old Subjects Mean Change in % of Time in Euglycemia (70-180 mg/dL)
Time frame: baseline and 3 months
Age 2-13 Years Old Subjects Mean Change in % of Time in Hyperglycemia (> 180 mg/dL)
Time frame: baseline and 3 months
Age 2-13 Years Old Subjects Mean Change in % of Time in Hypoglycemia (<70 mg/dL)
Time frame: baseline and 3 months
Age 2-13 Years Old - Number of Severe Hypoglycemic Event
Time frame: 3 months
Age 2-13 Years Old - Number of Diabetic Ketoacidosis (DKA) Event
Time frame: 3 months
Age 7-13 Years Old Subjects PLGM Performance - Event Rate Without Hypoglycemia at YSI-FST <=65 mg/dL
Time frame: Up to 12 hours after the start of PLGM period

Results and safety

Results posted to the registry on 11 Jan 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Subjects Wearing MMT-670G Insulin Pump	151	120

Primary outcome: Age 2-13 Years Old Subjects Change in A1C

Time frame: Baseline and end of 3-month study period. Mean (Standard Deviation). Unit: percentage of hemoglobin

Measure	Age 2-13 Years Old Wearing MMT-670G Insulin Pump n = 149
Value	-0.37 (0.62)

Population analysed: 2-13 years old subjects wearing MMT-670G insulin pump; two subjects end of study A1C not collected.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: 3 months for Study period, up to 3 years for Continued Access period.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Age 2-13 Yrs Study Period	0 of 151 (0%)	88 of 151 (58.3%)	0 of 151
Age 2-13 Yrs Continued Access Period	4 of 145 (2.8%)	113 of 145 (77.9%)	0 of 145

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35001477Forlenza GP, Ekhlaspour L, DiMeglio LA, Fox LA, Rodriguez H, Shulman DI, Kaiserman KB, Liljenquist DR, Shin J, Lee SW, Buckingham BA. Glycemic outcomes of children 2-6 years of age with type 1 diabetes during the pediatric MiniMed 670G system trial. Pediatr Diabetes. 2022 May;23(3):324-329. doi: 10.1111/pedi.13312. Epub 2022 Jan 31.
Derived from this study: PubMed 30585770Forlenza GP, Pinhas-Hamiel O, Liljenquist DR, Shulman DI, Bailey TS, Bode BW, Wood MA, Buckingham BA, Kaiserman KB, Shin J, Huang S, Lee SW, Kaufman FR. Safety Evaluation of the MiniMed 670G System in Children 7-13 Years of Age with Type 1 Diabetes. Diabetes Technol Ther. 2019 Jan;21(1):11-19. doi: 10.1089/dia.2018.0264. Epub 2018 Dec 26.
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.

11 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Insulin Pump in people with Type 1 Diabetes, run by Medtronic MiniMed, Inc. at 11 sites in 2 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 23 inclusion and 30 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 26 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States, Israel. 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 11 Jan 2019). 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?

Age 2-13 Years Old Subjects Change in A1C (time frame: Baseline and end of 3-month study period). 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 NCT02660827, which also lists 2 linked publications.

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 26 Jan 2022; AzTrials last refreshed its copy on 6 Nov 2026.