Diabetes Mellitus
Conditions
Brief summary
To investigate whether novel insight features in new Blood Glucose Monitoring System (BGMs) can improve glycemic control.
Interventions
DEVICELifeScan's new BGMS
LifeScan new Blood Glucose Monitoring System (BGMS)
Sponsors
LifeScan Scotland Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Summary: * Diagnosed with Type 1 diabetes mellitus or Type 2 diabetes mellitus for ≥ 3 month prior to screening * Currently performing self-monitoring of blood glucose (SMBG) at home for diabetes management decisions * Willingness to notify the study staff if they become pregnant during the study * Willing to sign an informed consent
Exclusion criteria
Summary: * Currently using a continuous or flash glucose monitoring * Currently pregnant or planning pregnancy within duration of study or breast feeding; subjects who become pregnant during the study will be withdrawn. * Conflict of Interest
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| A1c change from baseline after 12 weeks | 12 weeks | A1c change from baseline after 12 weeks in subjects using new BGMS compared to subjects' pre-study glycemic control |
Countries
United Kingdom
Contacts
Primary ContactMike Grady
Backup ContactKirsty Macleod
Outcome results
None listed