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Clinical Startup of the 670G Closed Loop Insulin Delivery System (670Gstartup)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03017482
Recruitment Status : Completed
First Posted : January 11, 2017
Last Update Posted : September 19, 2019
Sponsor:
Information provided by (Responsible Party):
Darrell M Wilson, Stanford University

Tracking Information
First Submitted Date January 7, 2017
First Posted Date January 11, 2017
Last Update Posted Date September 19, 2019
Actual Study Start Date July 15, 2017
Actual Primary Completion Date August 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 9, 2017)
percent of time patients are on the closed loop system [ Time Frame: 6 month ]
percent of time patients are on the closed loop system at 6 months after start of closed loop activation with a goal of >70%.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: January 9, 2017)
Percent time in range [ Time Frame: 6 months ]
Percent time in range (70 to 180 mg/dL) "Week 1 before closed loop but with predictive low glucose suspend (PLGS)" vs "Week 24 on full closed loop control."
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 9, 2017)
  • Severe Hypoglycemia [ Time Frame: 12 months ]
    Number of severe hypoglycemic events in 12 months on closed loop compared with the up to 12 months before by history before closed loop control
  • Diabetic Ketoacidosis [ Time Frame: 12 months ]
    Number of diabetic ketoacidosis (DKA) events in 12 months on closed loop compared with the up to 12 months before by history before closed loop control
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Clinical Startup of the 670G Closed Loop Insulin Delivery System
Official Title Clinical Startup of the 670G Closed Loop Insulin Delivery System
Brief Summary The purpose of this project is to track initiation and the first year of clinical use of the newly FDA approved 670G closed loop insulin delivery system by patients who have requested this system. Our goal is to evaluate our clinical approach to starting this newly approved system. Since the investigators are only following patients who have already decided to start the 670G, the investigator does not assign specific interventions to the subjects of the study; thus this is a Observational study.
Detailed Description

3.1 Initial Procedures After reviewing the patient's interest and eligibility, the investigators will obtain informed consent and assent as appropriate. The investigators will start the clinical process for starting an insulin infusion pump. This typically involves attending a pre-pump class (for those patients naïve to insulin pump therapy) and starting the process to obtain insurance coverage for the 670G system.

The investigators plan to track the insurance approval process, typically the number of calls and faxes required, as well as the result - approved vs not approved.

3.2 Pump Run-in (for those patients new to insulin infusion pumps) For patients who are insulin pump naïve the investigators will start on 670G insulin pump without the glucose sensor activation as per our existing clinical protocol. This may occur at a group visit.

3.3 Initial Visit

During at an initial visit, the following procedures will be performed:

  • A clinically obtained HbA1c assessment, typically done via fingerstick and DCA2000 (but any equivalent NGSP-certified point-of-care or laboratory based measurement within 2 weeks prior to enrollment acceptable)
  • Collection of medical history information including

    • Demographics (date of birth, gender, race and ethnicity), diabetes history, medical history, concomitant medications
    • Collect data for diabetes devices (eg meters, sensors, pumps)
    • Brief clinical physical exam including vital signs and skin assessment
    • CareLink account creation and sharing of access if this is not already done At this visit, patients will be taught how to insert and use the system glucose sensor.

3.3.1 Initial Week on the 670G System During the following week, the system (with both pump and sensor active) will be active with the PLGS on.

3.4 System Start Visit After the initial PLGS week, patients will be taught, perhaps as a group, the closed loop system and the system activated. (Note: multiple days of system data are required using the pump and sensor prior to the 670G system being capable of delivering additional insulin for hyperglycemia. Therefore, this stage of the start-up is a function of the system requirements.)

3.5 Weekly CareLink Download and Calls For each of the next four weeks, the patient/family will upload data into the CareLink system and the data will be reviewed by a member of the clinical team. Adjustments to system settings will be suggested to the family as clinically appropriate.

3.6 Routine 3, 6, 9 and 12 Month Clinical visits At a routine clinical visits the investigators will obtain an interval medical history, physical examination, collect and review of diabetes management data from all diabetes devices with an eye towards improving glycemic control. The investigators will collect adverse event information regarding severe hypoglycemia and diabetic ketoacidosis. Patients will be advised of suggested changes in pump settings

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with the clinical diagnosis of type 1 diabetes planning to start the 670G system clinically.
Condition Diabetes Mellitus, Type 1
Intervention Device: Medtronic 670G

This is an open labeled follow up of a clinical startup of a newly approved FDA closed loop insulin delivery system. It is essentially a "prospective" chart review of the clinically startup of a FDA closed loop system and has many elements of a quality improvement project with additional features of:

  • Questionnaires about the utility and impact of the device
  • Use of the device in children younger than the current FDA approval range
Study Groups/Cohorts Not Provided
Publications * Lal RA, Basina M, Maahs DM, Hood K, Buckingham B, Wilson DM. One Year Clinical Experience of the First Commercial Hybrid Closed-Loop System. Diabetes Care. 2019 Dec;42(12):2190-2196. doi: 10.2337/dc19-0855. Epub 2019 Sep 23.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 10, 2018)
85
Original Estimated Enrollment
 (submitted: January 9, 2017)
100
Actual Study Completion Date August 30, 2019
Actual Primary Completion Date August 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Clinical diagnosis of type 1 diabetes The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not required.
  2. Clinically planning to and be able to start the Medtronic 670G closed loop system
  3. Age greater than 7.00 years at the initiation of the 670G system
  4. Total daily insulin use of great than 8.0 units per day over a 1 week period
  5. Willing and able (access to internet from home) to download information into the Medtronic CareLink software

Exclusion Criteria:

  • 1) Current or planned pregnancy (for the next 12 months)
Sex/Gender
Sexes Eligible for Study: All
Ages 7 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03017482
Other Study ID Numbers 670Gstartup
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: No plan to share
Responsible Party Darrell M Wilson, Stanford University
Study Sponsor Stanford University
Collaborators Not Provided
Investigators
Principal Investigator: Darrell M Wilson, MD Stanford University
PRS Account Stanford University
Verification Date September 2019