Type 2 DiabetesI-KANNCT01408628

The I-KAN Study: Internet Insulin Education for Kansans

A study testing Internet Insulin Education in people with Type 2 Diabetes, run by David Robbins, MD at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Type 2 Diabetes
What is being tested?: Internet Insulin Education
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 51 participants
Where: 1 siteUnited States
Study dates: Aug 2011to Jan 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

The University of Kansas Medical Center
Kansas City, Kansas, 66160

Other trials in United States

About this study

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

Read the 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.

Conditions: Type 2 Diabetes
Being tested: Internet Insulin Education
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Internet Insulin EducationBehavioural
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.

Study groups in NCT01408628
Study group	Role	What they receive
Internet Insulin Education	Experimental	Single arm study; intervention represented by subjects' participation in 4 synchronous ("live") interactive Internet classes. Receives: Behavioral: Internet Insulin Education

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (2)

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.
Measured: 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
Measured: 6 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2011Jan 2015

First posted3 Aug 2011 (estimated)
Study startAug 2011
Primary completionSep 2014
Study completionJan 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 51 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01408628
Sponsor's protocol ID: 12634
Other IDs: 1R34DK089444-01A1
Acronym: I-KAN
Status last verified: Jul 2015
First submitted: 1 Aug 2011
Last updated: 24 Jul 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Type 2 Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The I-KAN Study: Internet Initiation of Insulin for Type 2 Diabetes in Kansas
ClinicalTrials.gov ID: NCT01408628
Acronym / sponsor ID: I-KAN / 12634
Conditions: Type 2 Diabetes
Study type: Interventional
Recruitment status: Completed
Enrolment: 51 participants (actual)
Lead sponsor: David Robbins, MDUniversity, hospital or other
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study start: Aug 2011
Primary completion: Sep 2014 (actual)
Study completion: Jan 2015 (actual)
First posted: 3 Aug 2011 (estimated)
Results: Posted 18 May 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Internet Insulin Education	Experimental	Behavioral: Internet Insulin EducationSingle arm study; intervention represented by subjects' participation in 4 synchronous ("live") interactive Internet classes.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (6 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Internet Insulin EducationOffer 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.	Behavioural	Internet Insulin Education

Primary outcome

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

2 secondary outcomes

Change in HbA1c
Time frame: Change from Baseline through Month 6 of follow-up period
Severity of Self-reported Hypoglycemia
Time frame: 6 Months

Results and safety

Results posted to the registry on 18 May 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Internet Insulin Education	51	39

Primary outcome: Frequency of Hypoglycemia

Time frame: 6-month follow up period following the Internet Intervention. Mean (Standard Deviation). Unit: incidents per person-year

Measure	Internet Insulin Education n = 25
Value	6.88 (11.20)

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

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 month follow up period post Internet intervention. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Internet Insulin Education	0 of 39 (0%)	10 of 39 (25.6%)	Not reported

Limitations and caveats (from the sponsor): This was a pilot study designed to compare rates of hypoglycemia among Internet managed type 2 patients to those from large clinical trials. It was not a placebo controlled trial.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

David Robbins, MD principal investigator

University of Kansas Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Internet Insulin Education in people with Type 2 Diabetes, run by David Robbins, MD at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 May 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency of Hypoglycemia (time frame: 6-month follow up period following the Internet Intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01408628.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2015.