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NCT04329871 Clinical Trial

Medtronic 670G Insulin Pump and the Impact on Glycemic Control, Quality of Life, and Compliance

Type 1 Diabetes Mellitus Clinical Trial

Official title:
An Analysis of Medtronic 670G Insulin Pump Use in Clinical Practice and the Impact on Glycemic Control, Quality of Life, and Compliance

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04329871
Other study ID # MetabolicRI
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 24, 2020
Est. completion date March 23, 2021

Study information
Verified date March 2020
Source Metabolic Research Institute, Inc.
Contact Paula M Dear
Phone 561-802-3060
Email pdear@metabolic-institute.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Analyze the Medtronic 670g pump on glycemic control

Description:

An Analysis of the Medtronic 670g Insulin pump use in clinical practice and the impact on glycemic control , quality of life, and compliance

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date March 23, 2021
Est. primary completion date March 23, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- age 18 or older

- Documented History of Type 1 Diabetes Mellitus

- 3 months continuous use of the Medtronic 670g pump system

- given written informed consent

Exclusion Criteria:

- Less than 3 months use of the Medtronic 670g pump system

- Taking any other medication, other than the insulin used in the Medtronic 670g pump, to manage their diabetes

- having medical conditions or taking medications that would preclude subject involvement or affect the outcomes being measured, in the opinion of the Investigator

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Metabolic Research Institute West Palm Beach Florida

Sponsors (1)
Lead Sponsor Collaborator
Metabolic Research Institute, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

There are no Citations

Outcome
Type Measure Description Time frame Safety issue
Primary Glycemic control while using the Medtronic MiniMed 670g system HbA1c, fructosamine, and glycomark will be compared between the participants last visit on previous insulin therapy and the last visit using the pump through study completion, an average of 1 year.
Secondary Efficacy of Quality of Life and satisfaction while using the MiniMed 670g system Diabetes Treatment Satisfaction, Diabetes-dependent Quality of Life, and Pump QOL vs Previous Therapy Questionnaires will be completed by each study participant through study completion, an average of 1 year
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