Medtronic 670G Insulin Pump and the Impact on Glycemic Control, Quality of Life, and Compliance
- Conditions
- Type 1 Diabetes Mellitus
- Registration Number
- NCT04329871
- Lead Sponsor
- Metabolic Research Institute, Inc.
- Brief Summary
Analyze the Medtronic 670g pump on glycemic control
- Detailed 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 & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Glycemic control while using the Medtronic MiniMed 670g system through study completion, an average of 1 year. HbA1c, fructosamine, and glycomark will be compared between the participants last visit on previous insulin therapy and the last visit using the pump
- Secondary Outcome Measures
Name Time Method Efficacy of Quality of Life and satisfaction while using the MiniMed 670g system through study completion, an average of 1 year Diabetes Treatment Satisfaction, Diabetes-dependent Quality of Life, and Pump QOL vs Previous Therapy Questionnaires will be completed by each study participant
Trial Locations
- Locations (1)
Metabolic Research Institute
đŸ‡ºđŸ‡¸West Palm Beach, Florida, United States