Type 2 Diabetes
Conditions
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.
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.
Interventions
BEHAVIORALInternet 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.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
David Robbins, MD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Hypoglycemia | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1c | Change from Baseline through Month 6 of follow-up period | 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. |
| Severity of Self-reported Hypoglycemia | 6 Months | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 51 |
| Total | 51 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| 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 |
| Consented | Withdrawal by Subject | 12 |
Baseline characteristics
| Characteristic | Internet Insulin Education |
|---|---|
| A1c Baseline | 8.61 Percentage (glycosolated hemoglobin) STANDARD_DEVIATION 1.63 |
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 15 Participants |
| Age, Categorical Between 18 and 65 years | 36 Participants |
| Age, Continuous | 58.67 years STANDARD_DEVIATION 10.54 |
| Region of Enrollment United States | 51 participants |
| Sex: Female, Male Female | 27 Participants |
| Sex: Female, Male Male | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 10 / 39 |
| serious Total, serious adverse events | 0 / 39 |
Outcome results
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.
Time frame: 6-month follow up period following the Internet Intervention
Population: Subjects who both completed the Internet intervention AND the 6 months of follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Internet Insulin Education | Frequency of Hypoglycemia | 6.88 incidents per person-year | Standard Deviation 11.2 |
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.
Time frame: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Internet Insulin Education | Change in HbA1c | -1.33 percentage of glycosolated hemoglobin | Standard Deviation 1.44 |
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
Time frame: 6 Months
Population: Subjects who completed both the Internet intervention and the 6 months of follow up
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Internet Insulin Education | Severity of Self-reported Hypoglycemia | Grade 1 | 141 incidents (count) |
| Internet Insulin Education | Severity of Self-reported Hypoglycemia | Grade 2 | 1 incidents (count) |
| Internet Insulin Education | Severity of Self-reported Hypoglycemia | Grade 3 | 0 incidents (count) |