NCT01408628

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable type-2-diabetes

Timeline
Completed

Started Aug 2011

Typical duration for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 1, 2011

Completed
Same day until next milestone

Study Start

First participant enrolled

August 1, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 3, 2011

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
5 months until next milestone

Results Posted

Study results publicly available

May 18, 2015

Completed
Last Updated

July 24, 2015

Status Verified

July 1, 2015

Enrollment Period

3.1 years

First QC Date

August 1, 2011

Results QC Date

April 28, 2015

Last Update Submit

July 1, 2015

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Frequency of Hypoglycemia

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

    6-month follow up period following the Internet Intervention

Secondary Outcomes (2)

  • Change in HbA1c

    Change from Baseline through Month 6 of follow-up period

  • Severity of Self-reported Hypoglycemia

    6 Months

Study Arms (1)

Internet Insulin Education

EXPERIMENTAL

Single arm study; intervention represented by subjects' participation in 4 synchronous ("live") interactive Internet classes.

Behavioral: Internet Insulin Education

Interventions

Internet Insulin EducationBEHAVIORAL

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.

Internet Insulin Education

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Limitations and Caveats

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.

Results Point of Contact

Title
Virginia Lewis
Organization
University of Kansas Medical Center
vlewis@kumc.edu
913-588-2097

Study Officials

  • David Robbins, MD

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor and Director KU Diabetes Institute

Study Record Dates

First Submitted

August 1, 2011

First Posted

August 3, 2011

Study Start

August 1, 2011

Primary Completion

September 1, 2014

Study Completion

January 1, 2015

Last Updated

July 24, 2015

Results First Posted

May 18, 2015

Record last verified: 2015-07

Locations

US(1)