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 Hypoglycemia [ Time Frame: 6-month follow up period following the Internet Intervention ] [ Designated as safety issue: Yes ]Hypoglycemia was defined in the study as either a blood glucose reading <70 mg/dL or symptomatic to the patient/subject.
- Change in HbA1c [ Time Frame: Change from Baseline through Month 6 of follow-up period ] [ Designated as safety issue: Yes ]Change in HbA1c (average measure of the % of glycosolated hemoglobin in the blood over the past 3 months) from baseline to end of follow up period.
- Severity of Self-reported Hypoglycemia [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]Severity was defined by the scale used by the DCCT: grade 1 - subject was able to recognize and treat appropriately without assistance; grade 2 - subject required help from another person either to recognize or recognize/treat; grade 3 - subject required injection of glucagon or treatment in ER
|Study Start Date:||August 2011|
|Study Completion Date:||January 2015|
|Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
Experimental: Internet Insulin Education
Single arm study; intervention represented by subjects' participation in 4 synchronous ("live") interactive Internet classes.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01408628
|United States, Kansas|
|The University of Kansas Medical Center|
|Kansas City, Kansas, United States, 66160|
|Principal Investigator:||David Robbins, MD||The University of Kansas Medical Center|