This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for The I-KAN Study: Internet Insulin Education for Kansans (NCT01408628), a na na study. The primary outcome is Frequency of Hypoglycemia.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01408628 |
| Phase | NA |
| Condition | Type 2 Diabetes |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 51 |
| Arms in the primary outcome | n/a |
| Lead sponsor | David Robbins, MD |
| Results posted | Yes |
2. Clinical Question
Population
People with type 2 diabetes who participated in the Internet education intervention. For the primary outcome, the registry specifies a narrower population: participants who completed the intervention and the 6-month follow-up period.
Intervention
Internet Insulin Education, delivered as 4 weekly synchronous, interactive Internet classes. The study description concerns teaching insulin management in small groups.
Comparator
There was no separate comparator group. The study is recorded as a single-group study, and its allocation is listed as NA. Its results therefore cannot be read as a randomized comparison with usual care or another intervention.
Primary question
The primary outcome was the frequency of hypoglycemia during the 6-month follow-up after the Internet intervention, expressed as incidents per person-year. The registry defines hypoglycemia as a blood glucose reading <70 mg/dL or an episode that was symptomatic to the participant. The record does not report the observed frequency or an analysis of it.
The study rationale was to demonstrate that insulin-management teaching through live Internet sessions could be safe and provide a resource for rural diabetes care providers who might otherwise lack the time or staff to initiate insulin for patients who need it. That rationale describes the purpose of the study; it is not itself evidence that the intervention achieved those aims. Change in HbA1c and severity of self-reported hypoglycemia are listed as secondary outcomes, but their results are not reported in the registry record.
3. Trial Design
The I-KAN Study is recorded as a completed, single-group behavioral intervention study with an enrollment of 51. The intervention was Internet Insulin Education: participation in 4 weekly, synchronous, interactive Internet classes. The registry describes the classes as a way to teach insulin management in small groups. The study began in 2011-08, and primary completion is listed as 2014-09.
No separate control arm is listed. Allocation is NA, the model is single group, and masking is none. Thus, this is not a randomized, masked comparison between two treatment groups. The registry does not report a comparator receiving usual care or another educational approach. The absence of a comparator matters for interpretation: an outcome observed after the intervention cannot, by itself, distinguish intervention-related change from change over time or other influences.
The primary outcome was frequency of hypoglycemia during a 6-month follow-up period after the Internet intervention. The stated primary-outcome population consists of participants who completed both the intervention and that follow-up. Enrollment of 51 does not establish how many participants met that outcome-population definition; the number is not reported in the registry record.
The registry lists Change in HbA1c and Severity of Self-reported Hypoglycemia as secondary outcomes. It records 3 outcome measures and 0 analyses. The results and analysis details for the primary and secondary outcomes are not reported in the registry record. The study phase is listed as NA. The registry does not report the sample-size justification, an analysis plan, or whether interim analyses were planned.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Consented
| Stage | Internet Insulin Education |
|---|---|
| STARTED | 51 |
| COMPLETED | 39 |
| NOT COMPLETED | 12 |
Reasons for not completing this period:
| Reason | Internet Insulin Education |
|---|---|
| Withdrawal by Subject | 12 |
Started Classes/Intervention
| Stage | Internet Insulin Education |
|---|---|
| STARTED | 39 |
| COMPLETED | 39 |
| NOT COMPLETED | 0 |
Completed 6 Month Follow-Up
| Stage | Internet Insulin Education |
|---|---|
| STARTED | 39 |
| COMPLETED | 25 |
| NOT COMPLETED | 14 |
Reasons for not completing this period:
| Reason | Internet Insulin Education |
|---|---|
| Lost to Follow-up | 3 |
| Protocol Violation | 6 |
| Withdrawal by Subject | 5 |
Analysis population for the primary outcome, as defined in the registry: Subjects who both completed the Internet intervention AND the 6 months of follow up
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | Internet Insulin Education |
|---|---|---|
| Participants analysed | 51 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 36 |
| Age, Categorical: >=65 years | Participants | 15 |
| Age, Continuous | years | 58.67 (SD 10.54) |
| Sex: Female, Male: Female | Participants | 27 |
| Sex: Female, Male: Male | Participants | 24 |
| Region of Enrollment: United States | participants | 51 |
| A1c Baseline | Percentage (glycosolated hemoglobin) | 8.61 (SD 1.63) |
6. Primary Endpoint
The registry lists the primary outcome as Frequency of Hypoglycemia, measured over 6-month follow up period following the Internet Intervention.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | incidents per person-year |
| Endpoint classification | Event-Rate Endpoint |
The primary endpoint is Frequency of Hypoglycemia, measured over the 6-month follow-up period following the Internet intervention. The registry expresses it as incidents per person-year and identifies the endpoint parameter as a mean, with standard deviation as the measure of dispersion. Hypoglycemia is defined as a blood glucose reading <70 mg/dL or an episode symptomatic to the participant. The endpoint therefore includes both a measured glucose criterion and a symptom-based criterion.
In general, an event rate expresses the number of events relative to the amount of time people were observed. This is useful when participants may contribute different amounts of follow-up time: the rate puts event counts in relation to exposure time rather than treating all counts as if they arose over identical observation. The mean describes the average rate in the specified outcome population; the standard deviation describes how much individual observations vary around that mean. It is not a confidence interval and does not, by itself, show how precisely the mean has been estimated.
The registry limits the primary-outcome population to people who completed the intervention and all 6 months of follow-up. It does not report the observed mean rate, its standard deviation, or an inferential analysis. The endpoint definition is therefore available, but the posted results do not permit assessment of the observed frequency or its precision.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record gives a clear primary-outcome definition but does not report the primary outcome result. It identifies hypoglycemia frequency as incidents per person-year over the 6-month follow-up period and specifies a mean and standard deviation. However, it provides no observed mean, standard deviation, confidence interval, p-value, or analysis result for this outcome. The registry also reports 0 analyses. Accordingly, the record does not support a statistical conclusion about the observed frequency of hypoglycemia in the study population.
The secondary outcomes are Change in HbA1c and Severity of Self-reported Hypoglycemia. Their names do not establish whether either outcome changed, in what direction, or with what precision. Results for these outcomes are not reported in the registry record. A named outcome should not be treated as a reported finding.
Even if outcome estimates were available, the single-group design would limit what they could establish. A change measured after an educational intervention would describe the participants’ observed experience over time, but without a separate comparator it would not isolate the effect of the intervention from other possible influences. This is a general limitation of before-and-after or single-group evidence, not a claim about what occurred in I-KAN.
Precision and variability are also distinct. In general, a standard deviation describes variation among observations, whereas a confidence interval describes uncertainty around an estimated quantity. Neither should be inferred from the other without the relevant data and analysis. Because the primary estimate and its uncertainty are not reported, neither the size of the observed rate nor how precisely it was estimated can be evaluated from the registry record.
The registry’s stated purpose includes demonstrating safety and providing a resource for rural diabetes care providers. Those are aims, not results. The adverse-event entry reports 0 serious adverse events among 39 participants at risk and 10 other adverse events among 39 at risk. These counts do not provide an intervention-versus-control comparison, and the registry does not report event attribution or the details needed to interpret the other events. The serious-event count should therefore be read narrowly as the count recorded in that entry, not as proof that serious harm is impossible or that the intervention caused no harm.
Overall, the record describes an educational intervention, its primary endpoint, and limited adverse-event counts, but does not provide the clinical outcome analyses needed to judge the observed endpoint values or their statistical precision. No treatment-effect conclusion can be drawn from the information reported.
9. Statistical Methods Explained
The primary endpoint is an event rate rather than a simple proportion. In general, a proportion counts how many people experienced an event among a defined group. A rate relates the number of events to the time people were observed. Rates are useful when observation time differs across participants, because a person observed longer may have more opportunity to experience an event. The registry’s unit, incidents per person-year, indicates this exposure-time framing. The record does not report the observed rate or the exposure-time details used in its calculation.
What does the mean describe?
The registry specifies the mean as the endpoint parameter. In general, a mean is an average of the measured values in the analysis population. Here, the intended population is participants who completed the Internet intervention and the 6-month follow-up. The mean rate would describe the average event frequency for that defined group; it would not necessarily describe every enrolled participant, particularly if some did not complete the intervention or follow-up. The number included in the primary-outcome population is not reported in the registry record.
How should the standard deviation be read?
The registry identifies standard deviation as the measure of dispersion. In general, standard deviation describes how spread out observed participant-level values are around their mean. A larger spread indicates more variability across observations; it is not a measure of uncertainty in the estimated mean. A standard error or confidence interval would address precision of the estimate, but neither can be recovered from the record’s endpoint description alone. The registry does not report the primary endpoint’s mean, standard deviation, or confidence interval.
Why can rates be statistically challenging?
As a general statistical matter, event counts are often analyzed using count-data methods. A simple model may assume that the variability in counts follows a particular relationship to the average rate. If observed counts vary more than that assumption allows, over-dispersion may be present. Ignoring over-dispersion can make estimated uncertainty too small, so it can make evidence appear more precise than it is. The registry record does not report a model, a dispersion assessment, or any other analysis method for the primary endpoint; therefore, it is not possible to say which approach was used or whether over-dispersion was assessed.
The endpoint definition combines a glucose-reading threshold with symptoms reported by participants. In general, combining objective measurements and reported symptoms can capture different kinds of events, but it also means the operational definition depends on both measurement and participant experience. The record states the definition but does not report how the components were separately counted or how event reports were collected.
What do planning calculations mean?
In general, sample-size calculations describe how many observations a future study might need under specified assumptions. They are planning exercises, not results from participants, and should not be interpreted as observed power. The planning framework associated with this record is described as using a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect expressed as a stated fraction of the observed effect. Those assumptions describe a hypothetical two-arm planning calculation; they do not change the fact that I-KAN is recorded as a single-group study. The record does not report the actual observed effect needed to evaluate such a calculation. Any resulting planning figures would not establish the precision or power of the completed study.
In general, a confidence interval gives a range of values compatible with the data and analysis under the method’s assumptions. Its width communicates precision: a narrower interval indicates greater precision than a wider one, all else equal. A p-value, when reported, addresses compatibility with a specified statistical null model; it does not measure clinical importance or the probability that an intervention works. Neither a confidence interval nor a p-value for the primary outcome is reported in the registry record.
The appropriate reading is therefore constrained by the available statistical reporting. The endpoint’s scale, summary parameter, variability measure, time frame, and target population are defined. The observed estimate, its uncertainty, and the analytic method are absent. General statistical principles can explain what those methods would mean, but they cannot supply the missing study result.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists one primary outcome, Frequency of Hypoglycemia, and two secondary outcomes: Change in HbA1c and Severity of Self-reported Hypoglycemia. It records 3 outcome measures overall and 0 analyses. The outcomes are named, but the registry record does not report results for them, nor does it describe statistical tests or estimates.
When a study evaluates several outcomes, multiplicity can arise if many hypotheses are tested. In general, repeated testing can increase the chance of finding an apparently unusual result by chance. Analysts may address this through a prespecified testing hierarchy or an adjustment to inference. The record does not report whether any multiplicity strategy was planned or used. Without analysis results, it is not possible to assess how any multiplicity approach affected interpretation.
The primary outcome population includes only participants who completed the Internet intervention and the 6-month follow-up. The record does not give the number in that population, explain how participants who did not complete follow-up were handled, or report an imputation method. It also does not describe the extent or reasons for missing outcome data. In general, restricting an analysis to people with complete observations can be problematic if completion is related to outcomes or participant characteristics; whether that concern applies cannot be assessed from the registry record.
The record does not report whether the analysis followed an intention-to-treat principle, used another analysis population, or included adjusted analyses. These omissions make it difficult to determine how the analyzed participants were selected and how missingness was addressed. They also mean that the stated primary-outcome population should not be assumed to include everyone enrolled.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Internet Insulin Education | 0 | 39 | 0.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Internet Insulin Education | 10 of 39 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Internet Insulin Education |
|---|---|---|
| Hypoglycemia | Endocrine disorders | 10 of 39 |
The adverse-event entry lists the Internet Insulin Education group with 39 participants at risk for serious adverse events and 0 serious adverse events reported. It also lists 39 participants at risk for other adverse events and 10 other adverse events. These are registry counts; they are not a comparison between intervention and control groups, because the study is recorded as single group.
The entry does not report event rates over person-time, individual event descriptions for the other events, or whether events were judged related to the intervention. The serious adverse event terms are not reported in the registry record. The deaths value is not reported in the registry record, so it should not be read as a count of zero.
In general, adverse-event counts describe events recorded under the study’s reporting approach. A count of zero serious events in this entry does not establish that serious events could not occur, and a count of other events does not establish that the intervention caused them. The registry does not provide the comparison or attribution information needed to make those conclusions. These figures should be interpreted as limited descriptive safety reporting, not as a complete estimate of risk.
12. What the Result Does, and Does Not, Mean
The registry record establishes what I-KAN set out to study: live Internet insulin education for people with type 2 diabetes, with hypoglycemia frequency during follow-up as the primary endpoint. It also provides the endpoint definition, the intended outcome population, and the study’s single-group design. Those details are useful for understanding what a reported result would represent.
The record does not report the primary endpoint estimate or its analysis. It also does not report results for the secondary outcomes, an estimate of precision, or a statistical comparison. As a result, the posted information does not show how frequent hypoglycemia was in the defined population, whether HbA1c changed, or how self-reported hypoglycemia severity changed. It would be inappropriate to infer any of those findings from the study aims or outcome names.
The design also limits causal interpretation. In general, a single-group study can describe outcomes among participants, but it lacks a concurrent comparison group to help separate intervention-associated change from other influences. This limitation remains even when a study has a clearly defined endpoint. It does not mean that the intervention had no effect; it means that a causal effect cannot be established from a single-group comparison alone.
The adverse-event entry provides descriptive counts for serious and other events, but no comparator or attribution detail. The record therefore cannot establish that the intervention was safe in a broader sense or that the other events were caused by it. The study rationale identifies a potential resource for rural care providers, but the registry record does not report results that demonstrate whether that aim was achieved.
The most defensible conclusion is limited: the study’s intervention, design, and planned outcome definitions are recorded, while outcome analyses are not reported. Any stronger statement about benefit, lack of benefit, safety, or precision would go beyond the registry record.
13. Why This Trial Matters Statistically
I-KAN illustrates why the statistical design and the statistical reporting both matter. The registry defines an event-rate endpoint, including its time frame, event criteria, summary parameter, and target population. Those choices determine what the estimate would describe. Without the actual estimate, readers cannot assess the event frequency or its variability, even when the endpoint is described in detail.
The study also makes the role of a comparator clear. A single-group design can describe what happened to participants in the study, but it cannot provide the same contrast as a randomized control comparison. This distinction is important when the stated purpose includes demonstrating safety or value as a resource: those aims require evidence that is not established merely by naming them in a study description.
The difference between a planning calculation and an observed analysis is another important statistical distinction. A sample-size illustration can explore assumptions for a hypothetical design, but it is not an outcome result and it is not observed power. In this case, the planning framework describes equal allocation between two arms even though the registry records a single-group study. Readers should keep those design contexts separate.
Finally, the record demonstrates why missing analysis details matter. Enrollment, completion of the intervention, and completion of follow-up are not interchangeable populations. The primary endpoint is defined for participants who completed both intervention and follow-up, but the number meeting that definition and the handling of missing data are not reported. Transparent reporting of the analyzed population, estimate, uncertainty, and methods is essential for judging what an observed result can support.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
Several limitations specific to this record constrain interpretation. First, the study is recorded as single group, with no separate comparator and no masking. There is therefore no randomized control contrast in the registry record, and outcome changes cannot be attributed uniquely to the intervention. This is a design limitation, not evidence that outcomes did or did not change.
Second, the primary endpoint applies to people who completed the intervention and the 6-month follow-up. The registry does not report how many of the 51 enrolled participants met that definition, how many did not complete follow-up, or why any follow-up was missing. The primary-outcome population may therefore differ from the enrolled population, but the size and implications of any difference are not reported.
Third, the outcome definition combines a blood glucose reading <70 mg/dL with symptoms reported by the participant. The registry does not describe the separate contribution of each criterion or the process used to capture events. The endpoint’s stated definition is clear, but its measurement details are limited.
Fourth, the record gives no primary or secondary outcome analyses, estimates, confidence intervals, or analysis methods. It does not report a sample-size justification, missing-data strategy, multiplicity approach, or interim-analysis plan. These details are not reported in the registry record and should not be inferred from the study’s enrollment or its completed status.
Finally, the adverse-event entry has limited detail: it gives counts at risk and event counts but no event attribution, serious-event terms, or reported death count. These omissions prevent a fuller safety interpretation. Collectively, the limitations mean the registry record describes the study design and selected outcome definitions more completely than it describes the results.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: The I-KAN Study: Internet Insulin Education for Kansans — NCT01408628.
- Registry record last updated 2015-07-24; status last verified 2015-07.
- Results first posted 2015-05-18.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
The I-KAN Study, also titled Internet Initiation of Insulin for Type 2 Diabetes in Kansas, is recorded as a completed behavioral study with enrollment of 51 and a single-group design. Its intervention was Internet Insulin Education through 4 weekly live interactive Internet classes. The study began in 2011-08, and primary completion is listed as 2014-09.
The primary outcome was Frequency of Hypoglycemia during the 6-month follow-up after the intervention, defined as incidents per person-year. The registry specifies a mean and standard deviation and limits the primary-outcome population to participants who completed the intervention and follow-up. Change in HbA1c and Severity of Self-reported Hypoglycemia are listed as secondary outcomes.
The registry records 0 analyses and does not report outcome estimates or analysis results. Its adverse-event entry lists 0 serious adverse events and 10 other adverse events among 39 participants at risk in each category. The deaths value is not reported in the registry record.