Diabetes Care Management Trial of Telemetric Monitoring (TELEGAP)

Kaiser Permanente logo

Kaiser Permanente

Status

Completed

Conditions

Diabetes

Treatments

Device: Telemonitoring Device

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01775878
CN-08JMink-01

Details and patient eligibility

About

The study is a two-arm, parallel-comparison, single-blind, randomized controlled trial, and will be offered to Kaiser Permanente members aged 18 - 75 years old who present to the Santa Rosa Diabetes Care Management Center with Type 2 diabetes mellitus. Participants will be randomly assigned to one of two treatment arms. The telemedicine group or the group receiving usual care (the control group). This study hopes to show the usefulness of this telemonitoring technology and more specifically, to assess whether this device improves markers of control of diabetes, glycemic control, and cardiovascular risk factors

Enrollment

254 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 18 - 75 years old,
  • diagnosis of type 2 diabetes mellitus for at least 1 month,
  • eligible for and referred to the diabetes care management program,
  • HbA1c values in the range: 7.5% to 10.5%.

Exclusion criteria

  • Weight > 330 lbs,
  • estimated glomerular filtration rate (GFR) < 45,
  • unstable coronary artery disease,
  • severe peripheral vascular disease which restricted exercise,
  • end-stage liver disease,
  • undergoing treatment for cancer,
  • pregnant or not using appropriate birth control,
  • no broadband internet access in their homes.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

254 participants in 2 patient groups

Usual Care
No Intervention group
Description:
This arm received usual care from the diabetes care managers
Telemonitoring Device
Experimental group
Description:
Patients in this arm received a telemonitoring device installed in their homes
Treatment:
Device: Telemonitoring Device

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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