Clinical Startup of the 670G Closed Loop Insulin Delivery System (670Gstartup)
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|ClinicalTrials.gov Identifier: NCT03017482|
Recruitment Status : Completed
First Posted : January 11, 2017
Last Update Posted : September 19, 2019
|Condition or disease||Intervention/treatment|
|Diabetes Mellitus, Type 1||Device: Medtronic 670G|
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|
|Actual Enrollment :||85 participants|
|Official Title:||Clinical Startup of the 670G Closed Loop Insulin Delivery System|
|Actual Study Start Date :||July 15, 2017|
|Actual Primary Completion Date :||August 30, 2019|
|Actual Study Completion Date :||August 30, 2019|
- 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
- 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%.
- 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."
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03017482
|United States, California|
|Stanford, California, United States, 94305|
|Principal Investigator:||Darrell M Wilson, MD||Stanford University|