The I-KAN Study: Internet Insulin Education for Kansans (I-KAN)
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|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||Phase|
|Type 2 Diabetes||Behavioral: Internet Insulin Education||Not Applicable|
|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|
|Actual Primary Completion Date :||September 2014|
|Actual 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
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): 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|