NCT02660827

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
151

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2016

Longer than P75 for not_applicable

Geographic Reach
2 countries

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 16, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 21, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

April 18, 2016

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2018

Completed
1 month until next milestone

Results Posted

Study results publicly available

January 11, 2019

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
Last Updated

January 26, 2022

Status Verified

January 1, 2022

Enrollment Period

2.6 years

First QC Date

January 16, 2016

Results QC Date

October 22, 2018

Last Update Submit

January 24, 2022

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Age 2-13 Years Old Subjects Change in A1C

    Descriptive analysis of change in A1C from baseline to end of 3-month study period

    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)

    baseline and 3 months

  • Age 2-13 Years Old Subjects Mean Change in % of Time in Hyperglycemia (> 180 mg/dL)

    baseline and 3 months

  • Age 2-13 Years Old Subjects Mean Change in % of Time in Hypoglycemia (<70 mg/dL)

    baseline and 3 months

  • Age 2-13 Years Old - Number of Severe Hypoglycemic Event

    3 months

  • Age 2-13 Years Old - Number of Diabetic Ketoacidosis (DKA) Event

    3 months

  • +1 more secondary outcomes

Study Arms (1)

Hybrid closed loop

EXPERIMENTAL

All subjects will be wearing the MMT-670G insulin pump, using it with the closed loop algorithm

Device: Insulin Pump

Interventions

Insulin PumpDEVICE

Closed Loop Algorithm

Also known as: MMT-670G
Hybrid closed loop

Eligibility Criteria

Age2 Years - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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
  • Subject must have a minimum daily insulin requirement (Total Daily Dose) of greater than or equal to 8 units
  • 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)
  • +6 more criteria

You may not qualify if:

  • 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)
  • 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
  • +15 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

AMCR Institute

Escondido, California, 92025, United States

Location

Stanford Hospital and Clinics

Palo Alto, California, 94305, United States

Location

SoCal Diabetes

Torrance, California, 90505, United States

Location

Barbara Davis Center

Aurora, Colorado, 80045, United States

Location

Nemours Children's Clinic

Jacksonville, Florida, 32207, United States

Location

University of South Florida - USF Health

Tampa, Florida, 33620, United States

Location

Atlanta Diabetes Associates

Atlanta, Georgia, 30318, United States

Location

Rocky Mountain Diabetes and Osteoporosis Center

Idaho Falls, Idaho, 83404, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Sheba Medical Center

Tel Aviv, Israel

Location

Related Publications (2)

  • 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.

    PMID: 35001477DERIVED

  • 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.

    PMID: 30585770DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin Infusion Systems

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Drug Delivery SystemsDrug TherapyTherapeuticsInfusion PumpsEquipment and SuppliesArtificial OrgansSurgical Equipment

Results Point of Contact

Title
Vivian Chen, Statistician
Organization
Medtronic Minimed
vivian.chen@medtronic.com
8185763309

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2016

First Posted

January 21, 2016

Study Start

April 18, 2016

Primary Completion

November 28, 2018

Study Completion

February 1, 2021

Last Updated

January 26, 2022

Results First Posted

January 11, 2019

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

US(10)IL(1)