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CompletedNCT00935441Updated Sep 16, 2011

Effect of Case-Management Using Home Monitoring on Diabetes and Blood Pressure Outcomes

An interventional study of case management with telemonitoring and usual case management in Diabetes Mellitus, sponsored by Minneapolis Veterans Affairs Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-09-16.

Sponsored by Minneapolis Veterans Affairs Medical Center · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
460
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

This is a randomized trial designed to determine if adoption of the chronic care model in conjunction with nurse case management, home telemonitoring, and home HbA1c monitoring can improve glycemic control compared to patients receiving usual case management. We hypothesize that nurse case management, with home telemonitoring of blood sugars and home HbA1c measurement will result in additional improvements in glycemic control compared to isolated nurse case management. Specifically, the telemonitoring group will have an HbA1c 0.5% lower compared to usual nurse case management. Secondary aims include an additional 5 mmHg improvement in systolic blood pressure (among patients with hypertension at the time of enrollment), improved patient satisfaction with treatment, improved medication adherence, reduced incidence of hypoglycemia, and reduced case manager time in the telemonitoring/home HbA1c group compared with usual caes management. The study will enroll 460 diabetic patients with HbA1c values greater than 8.5%, age 75 years or younger, who have a active land-line for telephone communication. Patients will be enrolled and actively case managed for 9 months.

02

Conditions studied

  • Diabetes Mellitus

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Keywords

  • Diabetes mellitus
  • chronic care
  • case management
  • telemedicine
03

In context

Diabetes Mellitus

10,923 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.

This study's planned enrollment of 460 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Minneapolis Veterans Affairs Medical Center is the lead sponsor of 40 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Enrolled at Minneapolis VAMC,
  • Type 1 or 2 Diabetes,
  • HbA1c >8.5%,
  • active land-line telephone connection

Exclusion criteria

Exclusion Criteria:

  • Age >75 years,
  • primary care provider unwilling to have patient enrolled,
  • active dialysis,
  • resident of assisted living facility,
  • research participant in previous diabetes case management study,
  • life expectancy \<1 year,
  • severe mental health condition,
  • active substance abuse,
  • pregnant or planning on becoming pregnant
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
460 participants (estimated)

Study arms

  • Experimental
    Telemonitoring

    Case management with home telemonitoring for blood sugar and blood pressure plus home HbA1c measurement

    Behavioral: case management with telemonitoring

  • Active comparator
    Usual case management

    Case management

    Behavioral: usual case management

Interventions

  • Behavioralcase management with telemonitoring

    telephone contact with a case manager, home telemonitoring equipment for blood sugar and blood pressure, home HbA1c measurement

  • Behavioralusual case management

    telephone contact with a case manager

06

What researchers measure

Primary outcomes

  1. Glycemic control (HbA1c)

    Time frame: 9 months after enrollment

Secondary outcomes

  1. Systolic blood pressure control in patients with elevated blood pressure at baseline

    Time frame: 9 months after enrollment

07

Study locations

1 site
  • Minneapolis VAMC
    Minneapolis, Minnesota 55417, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 16, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00935441
Lead sponsor
Minneapolis Veterans Affairs Medical Center
Responsible party
Nacide Ercan-Fang (Principal Investigator, Minneapolis Veterans Affairs Medical Center) — Principal investigator
First posted
Jul 9, 2009
Start date
Jun 2009
Primary completion
Sep 2011
Completion
Sep 2011
Last update
Sep 16, 2011
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2011. You cannot join it, but the record below documents what was studied.

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