Clinical Startup of the 670G Closed Loop Insulin Delivery System

NCT03017482 | Completed

• 1 other identifier: 670Gstartup
• Study Type: observational
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

• percent of time patients are on the closed loop system

  percent of time patients are on the closed loop system at 6 months after start of closed loop activation with a goal of \>70%.

  6 month

Secondary Outcomes (1)

• Percent time in range

  6 months

Other Outcomes (2)

• Severe Hypoglycemia

  12 months

• Diabetic Ketoacidosis

  12 months

Interventions

Medtronic 670G DEVICE

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

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with the clinical diagnosis of type 1 diabetes planning to start the 670G system clinically.

You may qualify if:

• 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.
• Clinically planning to and be able to start the Medtronic 670G closed loop system
• Age greater than 7.00 years at the initiation of the 670G system
• Total daily insulin use of great than 8.0 units per day over a 1 week period
• Willing and able (access to internet from home) to download information into the Medtronic CareLink software

You may not qualify if:

• \) Current or planned pregnancy (for the next 12 months)

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

Related Publications (1)

• 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.

  PMID: 31548247 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Darrell M Wilson, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 7, 2017
• First Posted: January 11, 2017
• Study Start: July 15, 2017
• Primary Completion: August 30, 2019
• Study Completion: August 30, 2019
• Last Updated: September 19, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)