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

August 7, 2019 updated by: Gregory Goodwin, Boston Children's Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

96

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Boston Childrens Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 25 years (Child, Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Single institution clinic population.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Type 1 Diabetes patients treated with the Medtronic 670G
Type 1 Diabetes patients treated with the Medtronic 670G at Boston Childrens Hospital
Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Successful implementation of hybrid closed loop technology
Time Frame: 0-24 months
Percent of Type 1 Diabetes patients who were properly trained on the use of the 670G that continue to use Hybrid Closed Loop technology at 0, 6, 12, 18 and 24 months post training.
0-24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of hybrid closed loop technology on glycemic control
Time Frame: 0-24 months
Assess impact of hybrid closed loop technology on glycemic control by comparing hemoglobin A1c measurements 0-6 months prior to treatment versus 0-6, 6-12, 12-18, 18-24 months post treatment
0-24 months
Assess impact of hybrid closed loop technology on glycemic control by analysis of sensor glucose data.
Time Frame: 0-24 months.
Compare sensor glucose data: 1) percent time in range (70-180 mg/dl), 2)percent time in auto-mode, 3) percent time sensor usage versus hemoglobin A1c data over time.
0-24 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Children's Hospital

Investigators

  • Principal Investigator: Gregory Goodwin, MD, Boston Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 13, 2018

Primary Completion (Actual)

July 30, 2019

Study Completion (Actual)

July 30, 2019

Study Registration Dates

First Submitted

August 6, 2019

First Submitted That Met QC Criteria

August 7, 2019

First Posted (Actual)

August 9, 2019

Study Record Updates

Last Update Posted (Actual)

August 9, 2019

Last Update Submitted That Met QC Criteria

August 7, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-P00028472

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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