N/A
Completed N=51
The I-KAN Study: Internet Insulin Education for Kansans
Source: ClinicalTrials.gov NCT01408628 ↗Enrolled (actual)
51
Serious AEs
0.0%
Results posted
May 2015
Primary outcomePrimary: Frequency of Hypoglycemia — 6.88 incidents per person-year
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Frequency of Hypoglycemia |
6.88 | — |
| SECONDARY Change in HbA1c |
-1.33 | — |
| SECONDARY Severity of Self-reported Hypoglycemia |
141; 1; 0 | — |
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 250 mg/dl.
Data sourced from ClinicalTrials.gov (NCT01408628). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.