The I-KAN Study: Internet Insulin Education for Kansans
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.
|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|
- Frequency of symptomatic hypoglycemia [ Time Frame: 0 to 6 months ] [ Designated as safety issue: Yes ]
- Change in HbA1c; severity of self-reported hypoglycemia [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||August 2011|
|Estimated Study Completion Date:||July 2013|
|Estimated Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
|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.
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.
|Contact: Ann Walker, MS, RD, LDemail@example.com|
|Contact: Virginia L Lewis, MAfirstname.lastname@example.org|
|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 email@example.com|
|Contact: Virginia Lewis, MA 913-588-2097 firstname.lastname@example.org|
|Principal Investigator: David Robbins, MD|
|Principal Investigator:||David Robbins, MD||The University of Kansas Medical Center|