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

NCT ID: NCT04051632

Last Updated: 2019-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

96 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-13

Study Completion Date

2019-07-30

Brief Summary

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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

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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.

Conditions

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Biomedical Technology Type 1 Diabetes

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Type 1 Diabetes patients treated with the Medtronic 670G

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

Medtronic 670G insulin pump

Intervention Type DEVICE

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

Interventions

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Medtronic 670G insulin pump

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Gregory Goodwin

Senior Associate Physician in Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gregory Goodwin, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Locations

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Boston Childrens Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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IRB-P00028472

Identifier Type: -

Identifier Source: org_study_id

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