The I-KAN Study: Internet Insulin Education for Kansans (I-KAN)
|ClinicalTrials.gov Identifier: NCT01408628|
Recruitment Status : Completed
First Posted : August 3, 2011
Results First Posted : May 18, 2015
Last Update Posted : July 24, 2015
|Condition or disease||Intervention/treatment|
|Type 2 Diabetes||Behavioral: Internet Insulin Education|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||51 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The I-KAN Study: Internet Initiation of Insulin for Type 2 Diabetes in Kansas|
|Study Start Date :||August 2011|
|Primary Completion Date :||September 2014|
|Study Completion Date :||January 2015|
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.
- Frequency of Hypoglycemia [ Time Frame: 6-month follow up period following the Internet Intervention ]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 ]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 ]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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|