The I-KAN Study: Internet Insulin Education for Kansans

Study Overview
=================
Brief Summary
-----------------
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.

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.

Official Title
-----------------
The I-KAN Study: Internet Initiation of Insulin for Type 2 Diabetes in Kansas

Conditions
-----------------
Type 2 Diabetes

Intervention / Treatment
-----------------
* Behavioral: Internet Insulin Education


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Internet Insulin Education<br>Single arm study; intervention represented by subjects' participation in 4 synchronous (live) interactive Internet classes. | Behavioral: Internet Insulin Education<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of Hypoglycemia | Hypoglycemia was defined in the study as either a blood glucose reading <70 mg/dL or symptomatic to the patient/subject. | 6-month follow up period following the Internet Intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c | 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. | Change from Baseline through Month 6 of follow-up period | 
| Severity of Self-reported Hypoglycemia | 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 | 6 Months |