N/A
N=211
Glucose Meter Study
Diabetes Mellitus
Bottom Line
View on ClinicalTrials.gov: NCT00782496 ↗Enrolled (actual)
211
Serious AEs
8.5%
Results posted
Nov 2010
Primary outcome: Primary: Average Number of Weekly Post-Prandial Blood Glucose Tests Performed by Subjects Using Either Basic or Advanced Meter Features — 7.1; 10.2 number of post-prandial tests per week
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Education + new meter (Device); Education + new meter + feature activation (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Ascensia Diabetes Care
- Primary completion
- Sep 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Number of Weekly Post-Prandial Blood Glucose Tests Performed by Subjects Using Either Basic or Advanced Meter Features |
7.1; 10.2 | — |
| SECONDARY Percent of Level 2 Participants Who Rated Helpfulness of Advanced Meter Features as 1 or 2 |
72.4 | — |
Summary
The purpose of this study is to evaluate if the meal marker and reminder feature of the Contour meter along with education maintains or increases frequency of testing blood sugar after meals and enables behavioral changes that may lead to improvement in glycemic control.
Eligibility Criteria
Inclusion Criteria
- Persons with type 1 or type 2 diabetes
- Persons who are on a pump or are taking at least 1 mealtime injection of insulin a day
- Persons at least 21 years of age
- Persons willing to complete all study visits and study procedures including:
- Using the meal-marker + reminder feature regularly (Group 2 subjects only)
- Using the paper logbook provided (both Groups)
- Testing their BG at least 3 times a day during the entire study.
- Persons who are able to speak, read and understand English
- Persons who are currently performing self-testing of blood glucose at home routinely (at least 3 times per day) for 4 weeks or more
Exclusion Criteria
- Persons who have been using a CONTOUR, BREEZE or BREEZE 2 meter regularly during the previous 6 months
- Persons who test over 6 times/day regularly
- Persons who wear a BG sensor 2 weeks or more during each month.
- Persons with home heath aides who assist with their BG testing.
- Persons with the following impairments which, in the opinion of the investigator, would seriously compromise the integrity of the study:
- Significant visual impairment
- Significant hearing impairment
- Cognitive disorder
- Significant unstable co-morbidity (with notable change within the past 3 months)
- Any other condition as per investigator's discretion
Data sourced from ClinicalTrials.gov (NCT00782496). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.