NCT00018616

Brief Summary

This is a randomized controlled trial of adherence. The study involves monitoring and managing focused intervention in patients prescribed metformin.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at P50-P75 for phase_2 diabetes

Timeline
Completed

Started Oct 1999

Longer than P75 for phase_2 diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1999

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

July 3, 2001

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 5, 2001

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2004

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2005

Completed
Last Updated

September 23, 2009

Status Verified

September 1, 2009

Enrollment Period

4.3 years

First QC Date

July 3, 2001

Last Update Submit

September 21, 2009

Conditions

Diabetes

Keywords

complianceMEMSmetformin

Study Arms (1)

1

OTHER
Behavioral: MEMS caps

Interventions

MEMS capsBEHAVIORAL
1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Metformin has been prescribed
  • Willing to use medication containers with MEMS caps
  • Capable of giving informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Connecticut Health Care System (West Haven)

West Haven, Connecticut, 06516, United States

Location

MeSH Terms

Conditions

Diabetes MellitusPatient Compliance

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Marc I. Rosen, MD

    VA Connecticut Health Care System (West Haven)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
FED

Study Record Dates

First Submitted

July 3, 2001

First Posted

July 5, 2001

Study Start

October 1, 1999

Primary Completion

January 1, 2004

Study Completion

January 1, 2005

Last Updated

September 23, 2009

Record last verified: 2009-09

Locations

US(1)