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| ID | Type | Description | Link |
|---|---|---|---|
| 1R34DK089444-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Internet Insulin Education | Experimental | Single arm study; intervention represented by subjects' participation in 4 synchronous ("live") interactive Internet classes. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Internet Insulin Education | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change from Baseline through Month 6 of follow-up period |
| Severity of Self-reported Hypoglycemia |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Robbins, MD | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Consented |
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| Started Classes/Intervention |
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| Completed 6 Month Follow-Up |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Frequency of Hypoglycemia | Hypoglycemia was defined in the study as either a blood glucose reading <70 mg/dL or symptomatic to the patient/subject. | Subjects who both completed the Internet intervention AND the 6 months of follow up | Posted | Mean | Standard Deviation | incidents per person-year | 6-month follow up period following the Internet Intervention |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoglycemia | Endocrine disorders | Systematic Assessment | Of the 51 people enrolled on the study, 39 continued on to the intervention phase. The 12 people that withdrew before the intervention phase were not at risk for hypoglycemia since they had not started insulin. |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Virginia Lewis | University of Kansas Medical Center | 913-588-2097 | vlewis@kumc.edu |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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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 |
| 6 Months |
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| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| A1c Baseline | Mean | Standard Deviation | Percentage (glycosolated hemoglobin) |
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| Units | Counts |
|---|---|
| Participants |
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| Secondary | 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. | Subjects who both completed the Internet intervention and the six months of follow up | Posted | Mean | Standard Deviation | percentage of glycosolated hemoglobin | Change from Baseline through Month 6 of follow-up period |
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| Secondary | 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 | Subjects who completed both the Internet intervention and the 6 months of follow up | Posted | Number | incidents (count) | 6 Months |
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| 0 |
| 39 |
| 10 |
| 39 |
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| D004700 | Endocrine System Diseases |
| Title | Measurements |
|---|
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