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

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ClinicalTrials.gov Identifier: NCT00700908
Recruitment Status : Completed
First Posted : June 19, 2008
Last Update Posted : February 22, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease Intervention/treatment
Type 2 Diabetes Behavioral: automated telephone intervention vs. usual care

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Impact of an Automated Telephone Intervention on HbA1c in Type 2 Diabetes: A Randomized Controlled Trial
Study Start Date : June 2007
Primary Completion Date : June 2008
Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
Automated telephone intervention
Behavioral: automated telephone intervention vs. usual care
Active Comparator: 2
Usual care
Behavioral: automated telephone intervention vs. usual care


Outcome Measures

Primary Outcome Measures :
  1. Change in HbA1c [ Time Frame: three months ]

Secondary Outcome Measures :
  1. Change in adherence to SMBG frequency [ Time Frame: three months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00700908


Locations
United States, Minnesota
Primary Care Center University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Novo Nordisk A/S
Investigators
Principal Investigator: Judith Graziano, PhD, RN University of Minnesota - Clinical and Translational Science Institute
More Information

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT00700908     History of Changes
Other Study ID Numbers: 0701M99406
First Posted: June 19, 2008    Key Record Dates
Last Update Posted: February 22, 2013
Last Verified: February 2013

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
type 2 diabetes
telephone intervention
automated

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases