Diabetes Care Management Trial of Telemetric Monitoring | NCT01775878

Studies
Diabetes Care Management Trial of Telemetric Monitoring

NCT01775878

Sponsor

Kaiser Permanente

Status

Completed

Last Update Posted

Jan 25, 2013Estimated

Enrollment

254Actual

Phase

Not Applicable

Conditions

Diabetes

Interventions

Telemonitoring Device

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2009

Primary Completion Date

Jan 2011Actual

Completion Date

Jan 2011Actual

First Submitted Date

Jan 23, 2013

First Submission Date that Met QC Criteria

Jan 23, 2013

First Posted Date

Jan 25, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 23, 2013

Last Update Posted Date

Jan 25, 2013Estimated

Name	Class
Samsung Electronics	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

254Actual

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Telemonitoring Device	Device	Telemonitoring device was installed in patients' homes	Telemonitoring Device

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Jerry Minkoff, MD	Kaiser Permanente	Principal Investigator

Type	Date	Date Unknown
Release	Jan 6, 2015
Reset	Jan 12, 2015
Release	Oct 1, 2015
Reset	Oct 30, 2015

Submission Tracking

Estimated Results First Submitted Date

Jan 6, 2015

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Jan 6, 2015			Jan 12, 2015
Oct 1, 2015

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided