Clinical Trials Logo
  1. Home
  2. Type 1 Diabetes Mellitus
  3. NCT04329871
  4. Details
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
See also
  Status Clinical Trial Phase
Completed NCT04476472 - Omnipod Horizon™ Automated Glucose Control System Preschool Cohort N/A
Completed NCT03635437 - Evaluation of Safety and Diabetes Status Upon Oral Treatment With GABA in Patients With Longstanding Type-1 Diabetes Phase 1/Phase 2
Completed NCT04909580 - Decision Coaching for Youth and Parents Considering Insulin Delivery Methods for Type 1 Diabetes N/A
Active, not recruiting NCT00679042 - Islet Transplantation in Type 1 Diabetic Patients Using the University of Illinois at Chicago (UIC) Protocol Phase 3
Completed NCT03293082 - Preschool CGM Use and Glucose Variability in Type 1 Diabetes N/A
Completed NCT04016662 - Automated Insulin Delivery in Elderly With Type 1 Diabetes (AIDE T1D) Phase 4
Completed NCT02527265 - Afrezza Safety and Pharmacokinetics Study in Pediatric Patients Phase 2
Completed NCT03738865 - G-Pen Compared to Glucagen Hypokit for Severe Hypoglycemia Rescue in Adults With Type 1 Diabetes Phase 3
Completed NCT03240432 - Wireless Innovation for Seniors With Diabetes Mellitus N/A
Completed NCT03168867 - Effectiveness Trial of an E-Health Intervention To Support Diabetes Care in Minority Youth (3Ms) N/A
Completed NCT03674281 - The VRIF Trial: Hypoglycemia Reduction With Automated-Insulin Delivery System N/A
Completed NCT03669770 - Ultrasound Classification and Grading of Lipohypertrophy and Its Impact on Glucose Variability in Type 1 Diabetes
Recruiting NCT03682640 - Azithromycin Insulin Diet Intervention Trial in Type 1 Diabetes Phase 2
Recruiting NCT04096794 - Chinese Alliance for Type 1 Diabetes Multi-center Collaborative Research
Completed NCT02882737 - The Impact of Subcutaneous Glucagon Before, During and After Exercise a Study in Patients With Type 1 Diabetes Mellitus N/A
Recruiting NCT02745808 - Injectable Collagen Scaffold™ Combined With HUC-MSCs for the Improvement of Erectile Function in Men With Diabetes Phase 1
Completed NCT02558491 - Feasibility of a Decision Support System to Reduce Glucose Variability in Subject With T1DM N/A
Withdrawn NCT02579148 - Collagen Scaffolds Loaded With HUCMSCs for the Improvement of Erectile Function in Men With Diabetes Phase 1
Completed NCT02596204 - Diabetes Care Transformation: Diabetes Data Registry and Intensive Remote Monitoring N/A
Completed NCT02562313 - A Trial Investigating the Continuous Subcutaneous Insulin Infusion of a Liquid Formulation of BioChaperone Insulin Lispro in Comparison to Humalog® Phase 1

External Links