diabetes Diabetes Mellitus
Conditions
Interventions
In this study the following assessments / evaluations should be done:
- 4 time bloodcollection for HbA1c measurement.
- collection of 2 urine samples.
- subject should answer 6 questionnaires.
- daily
Sponsors
Disetronic Medical System AG
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Subjects must be 18 years or older at the time of the screening visit • Subjects must have an HbA1c
Exclusion criteria
Exclusion criteria: • Subjects who used systemic oral or inhaled steroids for > 14 days within the last 3 months • Subjects on Chemotherapy or Radiation therapy (self-reported) • Subjects currently addicted to alcohol or substances of abuse as determined by the investigator • Subjects planning to relocate or travel extensively (for periods of more than 2 weeks during phase I of the study • Subjects with psychological issues which would impair ability to consent or participate (at the Physicians* discretion) • Subjects show have had severe hypoglycemia requiring 3rd party assistance within the last 4 weeks • Subjects who are either pregnant or lactating or are currently planning a pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| End point data for this study will be obtained from the following sources: 1: From pump downloads: 2: From meter downloads: 3: From Diary 4 :From Questionnaires | — |
Secondary
| Measure | Time frame |
|---|---|
| Not Applicable. | — |
Countries
Netherlands
Outcome results
None listed