Diabetes Care Management Trial of Telemetric Monitoring

A Randomized Study Comparing Usual Diabetes Care Management to Telemetric Home-based Monitoring of Glucose and Blood Pressure in Patients With Diabetes (TELEGAP)

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01775878

Acronym

TELEGAP

Enrollment

254

Registered

2013-01-25

Start date

2009-05-31

Completion date

2011-01-31

Last updated

2013-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes

Keywords

Diabetes, HbA1c, Fructosamine, Blood Pressure, Telemonitoring

Brief summary

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

Interventions

DEVICETelemonitoring Device

Telemonitoring device was installed in patients' homes

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Fructosamine	6 weeks	Change from baseline to 6 weeks in serum fructosamine levels
glycosylated hemoglobin	6 months	change from baseline to 6 months in serum HbA1c levels

Secondary

Measure	Time frame	Description
blood pressure	6 weeks and 6 months	goal of systolic \< 130 mmHg and diastolic \< 70 mmHg

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026