Type 1 Diabetes, Type 2 Diabetes
Conditions
Keywords
Remote monitoring, Type 1 Diabetes, Type 2 diabetes
Brief summary
The primary objective of this study is to determine whether remote monitoring in diabetes management is more effective at helping patients manage their disease than a standard disease management program.
Detailed description
To determine whether remote monitoring in diabetes management is more effective at helping patients manage their disease.
Interventions
BEHAVIORALDM-Standard
Device/t+ Medical Diabetes Management System
BEHAVIORALDisease Management Plus
Plus is one of the randomized arms of the study. Patients assigned to this arm receive support from Disease Management nurses and technology.
Sponsors
LifeScan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Between 18 and 64 years of age as of January 1, 2008 * Diagnosis of diabetes mellitus (listed ICD-9-CM diagnosis code on two or more outpatient claims, or on one or more inpatient admissions or emergency room claims in the most recent 12-month period) * Continuously enrolled in a health plan with pharmacy and medical benefits for the most recent 12-month period or with one period of non-enrollment up to only 30 days * Able to provide written informed consent for study participation
Exclusion criteria
* Advanced renal disease (one or more claims in the most recent 12-month period) as defined by a claim for nephropathy or creatinine greater than 2.5 mg/dl * Selected cancers (one or more claims in the most recent 12-month period) * HIV/AIDS (one or more claims in the most recent 12-month period) * Heart, liver, kidney, or multiple organ transplant (one or more claims in the most recent 12-month period) * Cirrhosis of the liver (one or more claims in the most recent 12-month period) * Current participation in another LifeScan study or other diabetes-related clinical trials * Medicare is primary source of insurance coverage * Unable to understand written and spoken English
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary study measures for this study include glycemic control and LDL levels, satisfaction with diabetes care, and adherence to diabetes medications and self-monitoring recommendations | 1 Year |
Secondary
| Measure | Time frame |
|---|---|
| Secondary measures include diabetes-related health-care utilization and physiologic data. | 1 Year |
Countries
United States
Outcome results
None listed