The I-KAN Study: Internet Insulin Education for Kansans

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
David Robbins, MD, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT01408628
First received: August 1, 2011
Last updated: May 26, 2015
Last verified: May 2015
  Purpose

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.


Condition Intervention
Type 2 Diabetes
Behavioral: Internet Insulin Education

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: The I-KAN Study: Internet Initiation of Insulin for Type 2 Diabetes in Kansas

Resource links provided by NLM:


Further study details as provided by University of Kansas:

Primary Outcome Measures:
  • Frequency of Hypoglycemia [ Time Frame: 6-month follow up period following the Internet Intervention ] [ Designated as safety issue: Yes ]
    Hypoglycemia was defined in the study as either a blood glucose reading <70 mg/dL or symptomatic to the patient/subject.


Secondary Outcome Measures:
  • Change in HbA1c [ Time Frame: Change from Baseline through Month 6 of follow-up period ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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


Enrollment: 51
Study Start Date: August 2011
Study Completion Date: January 2015
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01408628

Locations
United States, Kansas
The University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
David Robbins, MD
Investigators
Principal Investigator: David Robbins, MD The University of Kansas Medical Center
  More Information

No publications provided

Responsible Party: David Robbins, MD, Professor and Director KU Diabetes Institute, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT01408628     History of Changes
Other Study ID Numbers: 12634, 1R34DK089444 - 01A1
Study First Received: August 1, 2011
Results First Received: April 28, 2015
Last Updated: May 26, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 01, 2015