Analysis of Glycemic Control in Type 1 Diabetes Patients Using Hybrid Closed Loop Insulin Pump Therapy (Medtronic 670G)

Analysis of Glycemic Control in Type 1 Diabetes Patients Using Hybrid Closed Loop Insulin Pump Therapy (Medtronic 670G)

Sponsors

Lead Sponsor: Boston Children’s Hospital

Source Boston Children’s Hospital
Brief Summary

Observational study of patients at Boston Childrens Hospital with type 1 diabetes (T1D) who elected to treat their diabetes with the Medtronic 670 G hybrid closed loop insulin pump.

Detailed Description

Outcome study of 90-100 patients with type 1 diabetes who elected to use the Medtronic 670G.

Major outcome measure was to assess the percent of patients who were able to successfully continue to use the 670G technology over time.

Additional outcome variables included hemoglobin A1c pre and post treatment with the 670G, time in desired glucose range 70-180.

Overall Status Completed
Start Date June 13, 2018
Completion Date July 30, 2019
Primary Completion Date July 30, 2019
Study Type Observational
Primary Outcome
Measure Time Frame
Successful implementation of hybrid closed loop technology 0-24 months
Secondary Outcome
Measure Time Frame
Impact of hybrid closed loop technology on glycemic control 0-24 months
Assess impact of hybrid closed loop technology on glycemic control by analysis of sensor glucose data. 0-24 months.
Enrollment 96
Condition
Intervention

Intervention Type: Device

Intervention Name: Medtronic 670G insulin pump

Description: percent of patients who continue to use Medtronic 670G over time impact of 670G on glycemic control: hemoglobin A1c, time in range

Arm Group Label: Type 1 Diabetes patients treated with the Medtronic 670G

Eligibility

Sampling Method: Non-Probability Sample

Criteria:

Inclusion Criteria:

- clinical diagnosis of T1D

- patient of Boston Childrens Hospital diabetes program

- deemed to be adequate candidates for hybrid closed loop technology by their diabetes health care team

- patient received Medtronic 670G training at Boston Childrens Hospital

- patient received follow up diabetes care at Boston Childrens Hospital for at least 3 months after starting on the 670G

Exclusion Criteria:

- patients not trained at Boston Childrens Hospital or self started

Gender: All

Minimum Age: 5 Years

Maximum Age: 25 Years

Overall Official
Last Name Role Affiliation
Gregory Goodwin, MD Principal Investigator Boston Children’s Hospital
Location
Facility: Boston Childrens Hospital
Location Countries

United States

Verification Date

August 2019

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Boston Children’s Hospital

Investigator Full Name: Gregory Goodwin

Investigator Title: Senior Associate Physician in Medicine

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Label: Type 1 Diabetes patients treated with the Medtronic 670G

Description: Type 1 Diabetes patients treated with the Medtronic 670G at Boston Childrens Hospital

Patient Data No
Study Design Info

Observational Model: Case-Only

Time Perspective: Retrospective

Source: ClinicalTrials.gov