Type 1 Diabetes Mellitus
Conditions
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
Interventions
None listed
Sponsors
Metabolic Research Institute, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
Primary ContactPaula M Dear
Backup ContactAdriana Donadio
Outcome results
None listed