Diabetes Mellitus
Conditions
Keywords
Telemedicine, Diabetes Mellitus
Brief summary
The IDEATel study is a multicenter randomized controlled trial to evaluate the efficacy, acceptability, and cost-effectiveness of telemedicine case management to provide diabetes care to elderly Medicare beneficiaries residing in medically underserved areas of New York State.
Detailed description
The project is designed as a randomized controlled trial with approximately 750 subjects receiving a telemedicine intervention and approximately 750 receiving usual care. Eligibility requires having diabetes, being a Medicare beneficiary, and living in a medically underserved area. The project is conducted in New York City, in northern Manhattan (urban component), and in rural upstate New York through a consortion of participating institutions based at the State University of New York (SUNY) Upstate Medical University at Syracuse (rural component). Subjects are randomized to receive telemedicine case management or usual care for diabetes. The intervention utilizes a home telemedicine unit (HTU). The HTU is a specially designed, web-enabled device with a data port connected to a home glucometer and home blood pressure cuff whereby measurements obtained with these devices can be directly uploaded to a computer database. A diabetes nurse case manager interacts regularly with intervention participants through videoconference via the HTU.
Interventions
DEVICETelemedicine Unit (HTU)
This study involves the deployment of a home telemedicine unit (HTU). The HTU provides 3 critical functions for patients: videoconferencing, access to information resources and e-mail through a web-enabled workstation, and medical data acquisition through an electronic device interface. The HTUs also included a glucometer and a blood pressure cuff interfaced directly with the HTU.
OTHERusual care
usual diabetes care, as provided by primary care providers
Sponsors
State University of New York - Upstate Medical University
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 55 years or greater * Being a current Medicare beneficiary (verified by the Centers for Medicare and Medicaid Services) * Having diabetes mellitus as defined by a physician's diagnosis and being on treatment with diet, an oral hypoglycemic agent, or insulin * Residence in a federally designated medically underserved area (either of two federal designations, Medically Underserved Area \[MUA\] or Health Manpower Shortage Area \[HPSA\]) in New York Sate * Fluency in either English or Spanish
Exclusion criteria
* Moderate or severe cognitive, visual, or physical impairment * The presence of severe co-morbid disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hemoglobin A1c Levels | 5 years |
| Blood Pressure Levels | 5 years |
| Serum Lipids Levels; Low-density Lipoprotein (LDL)-Cholesterol | 5 years |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Telemedicine Case Management Telemedicine case management was performed through regular video-calls between a nurse case manager and the participant, with upload of blood glucose and blood pressure data (taken by the participant) through the telemedicine unit. | 844 |
| Usual Care Usual care consisted of continuing routine medical care, as prior to enrollment. Thus, diabetes management was performed by the participant's Primary Care Provider. | 821 |
| Total | 1,665 |
Baseline characteristics
| Characteristic | Telemedicine Case Management | Usual Care | Total |
|---|---|---|---|
| Age, Continuous | 70.8 years STANDARD_DEVIATION 6.5 | 70.9 years STANDARD_DEVIATION 6.8 | 70.8 years STANDARD_DEVIATION 6.7 |
| Sex: Female, Male Female | 536 Participants | 510 Participants | 1046 Participants |
| Sex: Female, Male Male | 308 Participants | 311 Participants | 619 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 844 | 0 / 821 |
| serious Total, serious adverse events | 0 / 844 | 0 / 821 |
Outcome results
Primary
Blood Pressure Levels
Time frame: 5 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telemedicine Case Management | Blood Pressure Levels | 135.83 mmHg | Standard Error 0.87 |
| Usual Care | Blood Pressure Levels | 140.15 mmHg | Standard Error 0.86 |
Primary
Hemoglobin A1c Levels
Time frame: 5 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telemedicine Case Management | Hemoglobin A1c Levels | 7.09 A1c percentage | Standard Error 0.06 |
| Usual Care | Hemoglobin A1c Levels | 7.38 A1c percentage | Standard Error 0.06 |
Primary
Serum Lipids Levels; Low-density Lipoprotein (LDL)-Cholesterol
Time frame: 5 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telemedicine Case Management | Serum Lipids Levels; Low-density Lipoprotein (LDL)-Cholesterol | 91.13 mg/dL | Standard Error 1.43 |
| Usual Care | Serum Lipids Levels; Low-density Lipoprotein (LDL)-Cholesterol | 94.97 mg/dL | Standard Error 1.4 |