The I-KAN Study: Internet Insulin Education for Kansans

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by University of Kansas
Sponsor:
Collaborator:
Information provided by (Responsible Party):
David Robbins, MD, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT01408628
First received: August 1, 2011
Last updated: April 2, 2014
Last verified: April 2014
  Purpose

The primary purpose of the study is demonstration that teaching insulin management in small groups of type 2 diabetes patients in 4 weekly "live" Internet sessions is safe and provides an important resource for rural diabetes care providers who may otherwise, because of lack of time or staff, not be able to put patients on insulin who need it.


Condition Intervention
Type 2 Diabetes
Behavioral: Internet Insulin Education

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: The I-KAN Study: Internet Initiation of Insulin for Type 2 Diabetes in Kansas

Resource links provided by NLM:


Further study details as provided by University of Kansas:

Primary Outcome Measures:
  • Frequency of symptomatic hypoglycemia [ Time Frame: 0 to 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change in HbA1c; severity of self-reported hypoglycemia [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: August 2011
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Internet Insulin Education Behavioral: Internet Insulin Education
Offer and assess the safety and effectiveness of a synchronous ("live") interactive 4-week Internet course designed to teach groups of type 2 diabetic patients to safely administer basal insulin without significant support from their usual source of diabetic management and to self-adjust the dose to achieve an HbA1c of ≤ 7.0% using an established treat-to-target algorithm.

Detailed Description:

The proposed project will test in a limited number of rural and semi-rural sites in the state of Kansas an innovative model of synchronous ("live") Internet initiation and intensification of once daily basal insulin glargine or detemir in type 2 diabetic patients that can be deployed statewide in a subsequent larger study (R18). The study's specific aims are to 1) develop a synchronous ("live") interactive Internet-administered course designed to teach groups of type 2 diabetic patients to safely administer basal insulin without significant support from their usual source of diabetic management and to self-adjust the dose to achieve a HbA1c ≤ 7.0% using a treat-to-target algorithm; and 2) to assess for the Internet patients selected clinical and psychometric outcomes. These will include HbA1c, frequency and severity of hypoglycemia, psychological resistance to insulin treatment, diabetes quality of life, and treatment satisfaction. The study builds upon the findings of the Treat-to-Target and INITIATE trials, as well as on successful Internet interventions for weight management, and both lays the conceptual foundation and gathers the expertise to successfully apply for the R18, which will have as primary aims addressing of delays to insulin therapy documented in the DAWN study and cost effectiveness analysis of the Internet intervention. The study hopes to show that Internet teaching of basal insulin therapy is comparable to traditional insulin management with respect to safety and effectiveness as measured against expected (published) results for frequency of hypoglycemia and percent of patients reaching target. Psychometric outcomes are exploratory - and hypothesis generating with respect to the subsequent R18 application.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • T2DM, meets provider criteria for insulin initiation; starting or having started insulin treatment no longer than six months prior to enrollment OR has not yet committed to starting insulin but has agreed to participate in the education
  • broadband Internet and experience with logging into a password-protected site (e.g., eCommerce or social networking);
  • ability to purchase or otherwise acquire glargine/detemir insulin and testing supplies.

Exclusion Criteria:

  • Use of oral glucocorticoids or second generation anti-psychotics;
  • previous use of self-administered insulin more than six months prior to enrollment;
  • gestational diabetes or other endocrine conditions causing hyperglycemia; treatment for a malignant condition other than basal cell carcinoma in situ within prior two years;
  • renal insufficiency (AST/ALT >2 or concurrent liver disease except NASH);
  • pregnant or planning to become pregnant within 6 months;
  • HbA1c ≤ 7.0% or ongoing weight loss or persistent fasting hyperglycemia > 250 mg/dl.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01408628

Contacts
Contact: Ann Walker, MS, RD, LD 913-588-6053 awalker5@kumc.edu
Contact: Virginia L Lewis, MA 913-588-2097 vlewis@kumc.edu

Locations
United States, Kansas
The University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Contact: Ann Walker, MS, RD, LD    913-588-1045    awalker5@kumc.edu   
Contact: Virginia Lewis, MA    913-588-2097    vlewis@kumc.edu   
Principal Investigator: David Robbins, MD         
Sponsors and Collaborators
David Robbins, MD
Investigators
Principal Investigator: David Robbins, MD The University of Kansas Medical Center
  More Information

No publications provided

Responsible Party: David Robbins, MD, Professor and Director KU Diabetes Institute, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT01408628     History of Changes
Other Study ID Numbers: 12634, 1R34DK089444 - 01A1
Study First Received: August 1, 2011
Last Updated: April 2, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014