The I-KAN Study: Internet Insulin Education for Kansans

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.

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.