Trial Outcomes & Findings for The I-KAN Study: Internet Insulin Education for Kansans (NCT NCT01408628)

Results Overview

Hypoglycemia was defined in the study as either a blood glucose reading \<70 mg/dL or symptomatic to the patient/subject.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

51 participants

Primary outcome timeframe

6-month follow up period following the Internet Intervention

Results posted on

2015-07-24

Participant Flow

Participant milestones

Participant milestones
Measure	Internet Insulin Education 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.
Consented STARTED	51
Consented COMPLETED	39
Consented NOT COMPLETED	12
Started Classes/Intervention STARTED	39
Started Classes/Intervention COMPLETED	39
Started Classes/Intervention NOT COMPLETED	0
Completed 6 Month Follow-Up STARTED	39
Completed 6 Month Follow-Up COMPLETED	25
Completed 6 Month Follow-Up NOT COMPLETED	14

Reasons for withdrawal

Reasons for withdrawal
Measure	Internet Insulin Education 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.
Consented Withdrawal by Subject	12
Completed 6 Month Follow-Up Lost to Follow-up	3
Completed 6 Month Follow-Up Protocol Violation	6
Completed 6 Month Follow-Up Withdrawal by Subject	5

Baseline Characteristics

The I-KAN Study: Internet Insulin Education for Kansans

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Internet Insulin Education n=51 Participants 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.
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	36 Participants n=99 Participants
Age, Categorical >=65 years	15 Participants n=99 Participants
Age, Continuous	58.67 years STANDARD_DEVIATION 10.54 • n=99 Participants
Sex: Female, Male Female	27 Participants n=99 Participants
Sex: Female, Male Male	24 Participants n=99 Participants
Region of Enrollment United States	51 participants n=99 Participants
A1c Baseline	8.61 Percentage (glycosolated hemoglobin) STANDARD_DEVIATION 1.63 • n=99 Participants

PRIMARY outcome

Timeframe: 6-month follow up period following the Internet Intervention

Population: Subjects who both completed the Internet intervention AND the 6 months of follow up

Hypoglycemia was defined in the study as either a blood glucose reading \<70 mg/dL or symptomatic to the patient/subject.

Outcome measures

Outcome measures
Measure	Internet Insulin Education n=25 Participants 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	6.88 incidents per person-year Standard Deviation 11.20

SECONDARY outcome

Timeframe: Change from Baseline through Month 6 of follow-up period

Population: Subjects who both completed the Internet intervention and the six months of follow up

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.

Outcome measures

Outcome measures
Measure	Internet Insulin Education n=25 Participants 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.
Change in HbA1c	-1.33 percentage of glycosolated hemoglobin Standard Deviation 1.44

SECONDARY outcome

Timeframe: 6 Months

Population: Subjects who completed both the Internet intervention and the 6 months of follow up

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

Outcome measures

Outcome measures
Measure	Internet Insulin Education n=25 Participants 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.
Severity of Self-reported Hypoglycemia Grade 1	141 incidents (count)
Severity of Self-reported Hypoglycemia Grade 2	1 incidents (count)
Severity of Self-reported Hypoglycemia Grade 3	0 incidents (count)

Adverse Events

Internet Insulin Education

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Internet Insulin Education n=39 participants at risk 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.
Endocrine disorders Hypoglycemia	25.6% 10/39 • Number of events 142 • 6 month follow up period post Internet intervention Adverse events were defined as hypoglycemic events (either a blood glucose reading \<70 or symptomatic hypoglycemia). Our formal data collection included only hypoglycemia as an adverse event. Subjects continued to see their primary care providers throughout the study for any medical issues unrelated to the intervention.

Additional Information

Virginia Lewis

University of Kansas Medical Center

Phone: 913-588-2097

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place