An interventional study of Internet Insulin Education in Type 2 Diabetes, sponsored by David Robbins, MD. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-07-24.
Sponsored by David Robbins, MD · Not applicable and Interventional
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.
9,590 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.
This study's enrollment of 51 is below the median of 81 across 7,713 interventional studies indexed under Diabetes Mellitus, Type 2.
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Exclusion Criteria:
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.
Frequency of Hypoglycemia
Hypoglycemia was defined in the study as either a blood glucose reading \<70 mg/dL or symptomatic to the patient/subject.
Time frame: 6-month follow up period following the Internet Intervention
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.
Time frame: 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
Time frame: 6 Months
| Milestone | Internet Insulin Education |
|---|---|
| Started | 51 |
| Completed | 39 |
| Not completed | 12 |
| Withdrew: Withdrawal by subject | 12 |
| Milestone | Internet Insulin Education |
|---|---|
| Started | 39 |
| Completed | 39 |
| Not completed | 0 |
| Milestone | Internet Insulin Education |
|---|---|
| Started | 39 |
| Completed | 25 |
| Not completed | 14 |
| Withdrew: Lost to follow-up | 3 |
| Withdrew: Protocol violation | 6 |
| Withdrew: Withdrawal by subject | 5 |
Hypoglycemia was defined in the study as either a blood glucose reading \<70 mg/dL or symptomatic to the patient/subject.
| incidents per person-year | Internet Insulin Education |
|---|---|
| Frequency of Hypoglycemia | 6.88 ± 11.20 |
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.
| percentage of glycosolated hemoglobin | Internet Insulin Education |
|---|---|
| Change in HbA1c | -1.33 ± 1.44 |
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
| incidents (count) | Internet Insulin Education |
|---|---|
| Grade 1 | 141 |
| Grade 2 | 1 |
| Grade 3 | 0 |
Collected over 6 month follow up period post Internet intervention. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Internet Insulin Education | — | 0/39 (0%) | 10/39 (25.6%) |
| Event | Internet Insulin Education |
|---|---|
| HypoglycemiaEndocrine disorders | 10/39 |
| Age, Categorical(Participants) | Internet Insulin Education |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 36 |
| >=65 years | 15 |
| Age, Continuous(years) | Internet Insulin Education |
|---|---|
| Mean | 58.67 ± 10.54 |
| Sex: Female, Male(Participants) | Internet Insulin Education |
|---|---|
| Female | 27 |
| Male | 24 |
| Region of Enrollment(participants) | Internet Insulin Education |
|---|---|
| United States | 51 |
| A1c Baseline(Percentage (glycosolated hemoglobin)) | Internet Insulin Education |
|---|---|
| Mean | 8.61 ± 1.63 |
This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.
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