Impact of an Automated Telephone Intervention on Glycosylated Hemoglobin (HbA1c) in Type 2 Diabetes - Full Text View

Sponsors and Collaborators:	University of Minnesota Novo Nordisk
Information provided by:	University of Minnesota
ClinicalTrials.gov Identifier:	NCT00700908

Purpose

Aim 1. Determine the impact of a daily, automated telephone intervention on HbA1c levels compared to standard care in older patients with type 2 diabetes.

Aim 2. Determine the impact of the automated telephone intervention compared to standard care on adherence to prescribed SMBG frequency in older patients with type 2 diabetes.

Aim 3. Determine the impact of the automated telephone intervention compared to standard care on self-reported diabetic control problems in older patients with type 2 diabetes.

Aim 4. Determine the impact of the automated telephone intervention compared to standard care on self-reported attitudes and health beliefs concerning diabetes in older patients with type 2 diabetes

Condition	Intervention
Type 2 Diabetes	Behavioral: automated telephone intervention vs. usual care

MedlinePlus related topics: Diabetes

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	The Impact of an Automated Telephone Intervention on HbA1c in Type 2 Diabetes: A Randomized Controlled Trial

Further study details as provided by University of Minnesota:

Primary Outcome Measures:

Change in HbA1c [ Time Frame: three months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in adherence to SMBG frequency [ Time Frame: three months ] [ Designated as safety issue: No ]

Enrollment:	120
Study Start Date:	June 2007
Study Completion Date:	June 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Automated telephone intervention	Behavioral: automated telephone intervention vs. usual care
2: Active Comparator Usual care	Behavioral: automated telephone intervention vs. usual care

Eligibility

Ages Eligible for Study:	55 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age greater or equal to 55
Type 2 diabetes
English speaking
Ability to use glucose meter

Exclusion Criteria:

Unable to give informed consent
Unwilling to allow SMBG levels to be shard with primary care physician

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00700908

Locations

United States, Minnesota
Primary Care Center University of Minnesota
Minneapolis, Minnesota, United States, 55455

Sponsors and Collaborators

University of Minnesota

Novo Nordisk

Investigators

Principal Investigator:

Judith Graziano, PhD, RN

University of Minnesota

More Information

Responsible Party:	University of Minnesota ( Judith A. Graziano, RN, PhD candidate )
Study ID Numbers:	0701M99406
Study First Received:	June 17, 2008
Last Updated:	June 18, 2008
ClinicalTrials.gov Identifier:	NCT00700908
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Minnesota:

type 2 diabetes
telephone intervention
automated

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on January 16, 2009