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 Evaluation of DIDGET TM World Reports (NCT00923975), a na na study. The primary outcome is Number of Participants Who Rated Successful (<=3) by Healthcare Professionals When Participants Performed Specific Software Tasks.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00923975 |
| Phase | NA |
| Condition | 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 | Ascensia Diabetes Care |
| Results posted | Yes |
2. Clinical Question
Population
The intended users were young adults, parents or guardians of young people under age 18, and healthcare professionals who work with this population. The study concerned people using a diabetes data management program; the registry record lists diabetes as the condition.
Intervention
Participants evaluated DIDGET World Web Community Reports. The program was intended to upload blood glucose results from the DIDGET meter to a secure website, where users could review results and recognize trends and patterns.
Comparator
There was no separate comparator group. The registry record classifies the study as single-group, with allocation listed as NA. It therefore does not provide a like-for-like control comparison.
Primary question
Could participants perform specified software tasks successfully, as rated by study staff, with success defined as a rating of 1, 2, or 3 on the five-point scale? A rating of 1 meant success without assistance; ratings of 2 and 3 allowed prompts or verbal assistance.
The clinical question is about software use, not a comparison of health outcomes. The stated purpose was to evaluate a diabetes data management program in the hands of potential users, including lay users and healthcare professionals. The endpoint focuses on the ability to complete specific tasks during an evaluation lasting 1-2 hours. It combines independent task completion with task completion involving some assistance, so its definition of success is broader than independent use alone.
The registry record does not report the number of participants meeting the primary endpoint, task-specific results, or a comparison with another software program or usual practice. It therefore documents the question the study set out to examine, but not a numerical answer to that question.
3. Trial Design
The registry record describes a completed, single-group evaluation with an enrollment of 51. The study tested DIDGET World Web Community Reports, a device intervention intended to upload blood glucose results from the DIDGET Blood Glucose Monitoring System to a secure website. The record describes intended users as young adults, parents or guardians of young people under age 18, and healthcare professionals working with this population.
Allocation is listed as NA, and the study model is single-group. Masking is listed as none. These design features mean the record does not describe random assignment or a blinded comparison. There is no separate control arm against which to judge task performance. The study is consequently best read as an evaluation of users’ experience with the software and their performance on selected tasks, rather than as a comparative trial of health effects.
The record lists the study start and primary completion as 2009-06 and gives the status as completed. Phase is listed as NA. Ascensia Diabetes Care is named as sponsor. The primary outcome was assessed over 1-2 hours; a separate timeframe for the secondary outcomes is not reported in the registry record.
The primary outcome description says study staff rated participants as they performed specific tasks. It also states that one subject was withdrawn and the data were not used in the analysis because the subject did not meet inclusion criteria. The record lists 50 participants at risk in the adverse-event group, but it does not provide a full account of the analysis population or clarify how the enrolled participants were distributed across all outcome analyses.
No protocol details beyond the registry descriptions are reported. In particular, the registry record does not report the task list, the software-use instructions given during assessment, or a detailed analysis plan. Those details should not be inferred from the study’s general purpose.
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.
Overall Study
| Stage | Intended Users of the Software |
|---|---|
| STARTED | 51 |
| COMPLETED | 50 |
| NOT COMPLETED | 1 |
Reasons for not completing this period:
| Reason | Intended Users of the Software |
|---|---|
| Did not meet inclusion criteria | 1 |
Analysis population for the primary outcome, as defined in the registry: One subject was withdrawn from the study and the data was not used in the analysis. The subject did not meet inclusion criteria.
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 | Intended Users of the Software |
|---|---|---|
| Participants analysed | 47 | |
| Age, Continuous | years | 26.9 (18 to 47) |
| Sex: Female, Male: Female | Participants | 29 |
| Sex: Female, Male: Male | Participants | 18 |
| Region of Enrollment: United States | participants | 47 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Participants Who Rated Successful (<=3) by Healthcare Professionals When Participants Performed Specific Software Tasks, measured over 1-2 hours.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the number of participants rated successful by healthcare professionals when performing specific software tasks. The stated assessment period is 1-2 hours. Study staff used a five-point scale: 1 indicated success without assistance; 2 indicated success after a prompt to view user instructions; 3 indicated success with verbal assistance or review of part of the instructions; 4 indicated inability to perform the task; and 5 indicated inability to perform it because of software or hardware failure after repeated attempt.
The endpoint classifies ratings of 1, 2, or 3 as successful. Thus, it includes both independent completion and completion with some kind of assistance. It is a measure of task performance under the conditions of the evaluation, not a measure of long-term use, user preference alone, or change in glucose control. The distinction matters when interpreting the word “successful”: a participant could meet the endpoint after receiving a prompt or verbal help.
Usability assessments use task performance because completing intended functions is one practical aspect of whether users can work with a program. This is a general rationale, not a reported protocol justification. The endpoint could describe the number meeting the defined threshold, but the registry record does not report that number, the number assessed for each task, or task-level results. It therefore does not establish how frequently participants completed the specified tasks successfully.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record establishes that the study was completed and describes its intended users, software, and primary task-success measure. It does not report a numerical primary outcome result. Although the endpoint is framed as a number of participants whose ratings were successful, no count or task-level breakdown is reported in the registry record. The three listed secondary outcome measures also have no results reported in the registry record.
This absence limits statistical interpretation. Without an outcome count, there is no posted estimate of the proportion of assessed participants meeting the success definition, and no confidence interval describing uncertainty around such an estimate. No estimate should be reconstructed from the enrollment or the adverse-event denominator: those figures do not give the endpoint result. Nor does the record report an inferential test for the task outcome.
The design also limits what any task-performance finding could answer. This was a single-group evaluation, with no like-for-like control comparison. A task rating could describe how participants performed in the evaluation setting, but the design does not establish how performance would compare with another program, another set of instructions, or another way of managing glucose data. There is no basis in the registry record for attributing a health outcome to the software.
The endpoint threshold includes assisted completion. That is useful to keep in view: a rating counted as successful could reflect a prompt to consult instructions or verbal help, not only unaided task completion. Because the task-specific results and distribution of ratings are not reported, it is not possible to separate independent performance from assisted performance in the posted results.
General statistical interpretation: an estimate is more informative when its precision is reported as well as its point value. A confidence interval describes a range of values compatible with the observed data under the statistical model; its width reflects uncertainty. No primary-outcome estimate or interval is reported in this registry record, so neither the magnitude nor precision of task success can be assessed from the posted results.
The record says one subject was withdrawn and the data were not used because the subject did not meet inclusion criteria. That exclusion is described, but the registry record does not provide a full account of participant flow or explain the handling of any other unavailable task ratings. The reported enrollment should not be treated as the denominator for every outcome. The adverse-event denominator is separately reported as 50.
Overall, the record is informative about the study’s purpose and outcome definition, but it does not contain enough outcome data to quantify task performance. The study’s completed status does not substitute for a posted result, and the lack of a comparator means the record does not support a comparative conclusion.
9. Statistical Methods Explained
General: What does a single-group design show? A single-group study observes participants under one set of study conditions rather than comparing separate intervention and control groups. It can describe performance or responses in the group studied. By itself, it cannot distinguish the effect of the software from other influences, such as familiarity with similar tools, the assessment setting, or help available during tasks. Those are general design considerations, not additional details reported about this study.
For this evaluation, the registry record identifies one group of intended software users and no separate comparator. Allocation is listed as NA. The design is therefore aligned with a usability-style assessment question, but it cannot provide a controlled estimate of a difference between software options. No randomized comparison is reported.
What does the primary endpoint count?
The primary endpoint is a participant count based on staff ratings of performance on specific tasks. Ratings 1 through 3 meet the endpoint definition. The scale distinguishes unaided completion from completion after prompts or verbal assistance, but the primary threshold combines these categories. Ratings 4 and 5 do not meet the stated threshold. The registry record does not report a count of participants meeting the threshold or results for each task, so the endpoint definition is available without its observed result.
General: A binary outcome reduces a more detailed experience to two categories, such as meeting or not meeting a specified criterion. The definition of the cutoff is consequential: different cutoffs can answer different questions. Here, the stated cutoff includes ratings involving assistance. That makes the endpoint a measure of success under the defined evaluation conditions, rather than a measure limited to independent completion.
What would an estimate and confidence interval contribute?
General: A point estimate gives the value calculated from the observed participants. A confidence interval communicates the uncertainty associated with that estimate under a statistical model. A narrow interval indicates greater precision than a wide interval, all else equal. An interval is not a guarantee about an individual participant’s experience, and it does not correct for limitations in the design or measurement.
The registry record does not report the primary estimate or a confidence interval. It is therefore not possible to assess either the observed level of task success or its statistical precision from the registry results. The enrollment count alone cannot supply either quantity.
How should planning illustrations be understood?
General: Sample-size calculations describe how many observations a hypothetical study might require under stated assumptions. They are planning tools, not observed outcomes and not evidence that a study had a particular probability of detecting an effect after it was completed. The registry record’s planning assumptions describe a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect set to a stated fraction of the observed effect. These are planning assumptions, not a description of the actual single-group design.
The record does not report a trial-specific sample-size justification or the assumptions used when the study was designed. Any planning illustration based on an observed effect should not be mistaken for the study’s original design rationale. It is also not observed power. No numerical planning result is reported in the registry record, and none can be inferred from the enrollment information alone.
Why can over-dispersion matter?
General: For count outcomes, a simple statistical model may assume that variability follows a particular relationship to the average count. Over-dispersion occurs when the observed variation is greater than that model expects. If it is ignored, standard errors can be too small and confidence intervals too narrow, making results appear more precise than they are. Whether such a concern applies depends on the outcome structure and data. The registry record does not report an over-dispersion assessment or a count-model analysis; the primary outcome is described as a number of participants meeting a task-rating threshold, and no analysis result is reported.
More broadly, statistical methods can only be evaluated when the analysis population, outcome data, and model are described. The registry record lists no analyses and does not report a statistical analysis plan. The scale description and endpoint threshold are documented, but the method used to calculate or compare outcome estimates is not reported in the registry record. It would be inappropriate to assume a particular model, adjustment, or hypothesis test.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists four outcome measures: the primary task-success measure and three secondary measures. The secondary measures concern ease of performing specific tasks, clarity and usefulness of user instructions, and satisfaction with specified aspects. The record does not report results for these outcomes.
When a study examines multiple outcomes, the chance of at least one apparently notable result can increase if each is tested separately without accounting for the collection of tests. General methods for addressing multiplicity include prioritizing a primary outcome, adjusting inferential thresholds, or treating additional outcomes as exploratory. The registry record does not report a multiplicity strategy, a hierarchy among secondary outcomes, or an analysis plan. Because no outcome analyses are listed, the posted record does not establish how multiplicity was handled.
The primary outcome description states that one subject was withdrawn and the data were not used because the subject did not meet inclusion criteria. This is the only specific exclusion described. It does not explain whether other task-level data were missing, how incomplete assessments were treated, or whether any participants were excluded from particular secondary analyses. Those details are not reported in the registry record.
The record does not provide a complete analysis population definition or participant flow for each outcome. The enrollment is 51, while the adverse-event group lists 50 participants at risk. These figures concern different registry entries and should not be treated as interchangeable outcome denominators. No imputation method, missing-data sensitivity analysis, or rule for handling partial task completion is reported in the registry record.
General: Missingness can affect interpretation when participants with incomplete observations differ from those with complete observations. A clear report ordinarily describes what was missing and how the analysis handled it. Without that information and without outcome results, the extent to which missing observations could affect the task-success findings cannot be assessed.
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 |
|---|---|---|---|
| Intended Users of the Software | 0 | 50 | 0.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Intended Users of the Software | 0 of 50 |
The adverse-event entry lists the intended-users group with 50 participants at risk. It reports 0 serious adverse events and 0 other adverse events. The deaths field is not reported in the registry record; it should not be read as a reported count of zero. These figures describe what the registry lists for this group and do not provide details about event types, assessment procedures, or the period over which events were collected.
A zero in a registry event count means that no events of that category are recorded in that entry. It does not establish that an event is impossible, nor does it by itself quantify how precisely the underlying event frequency is known. General: the amount of information conveyed by a zero count depends on the denominator, follow-up, and completeness of event reporting. The record supplies a denominator for this entry but does not report a safety follow-up timeframe.
The study evaluated software use and is not described as a comparison of medical treatments. The adverse-event figures should therefore be read as registry safety reporting for the study group, not as evidence about clinical effects or a comparative safety result. No safety comparison is available because the study has no separate comparator group.
12. What the Result Does, and Does Not, Mean
The registry record documents an evaluation of DIDGET World Reports by intended users and defines a task-performance endpoint. It establishes that study staff rated participants on specific software tasks and that ratings from unaided completion through completion with some assistance counted as successful. It also records a completed study with an enrollment of 51.
What the record does not establish is the observed level of task success. The primary outcome count and task-specific results are not reported in the registry record. The three listed secondary outcomes likewise have no posted results. Without those data, readers cannot determine how many participants met the primary threshold, how results varied by task, or how precisely performance was estimated.
The study also does not establish that the software improved glucose control, changed health outcomes, or performed better than another program. Such conclusions would require outcomes and comparisons that are not reported in this single-group evaluation. The record’s stated purpose concerns software evaluation, not a comparative clinical efficacy question.
General: A study can be useful for describing a focused assessment even when it cannot answer broader causal questions. The strength of the conclusion must match the design, outcome definition, and reported results. Here, the design and measurement definition are described, while the outcome findings needed to quantify performance are absent.
The task-success threshold includes assisted performance. Therefore, even a reported count meeting that threshold would need to be interpreted as success with or without specified help, not as a count of participants who completed every task independently. Because the rating distribution is not reported, the balance between unaided and assisted completion is also unknown.
13. Why This Trial Matters Statistically
This study raises a practical statistical issue: the meaning of an outcome depends on how it is defined and reported. “Successful” sounds straightforward, but the registry’s threshold includes several rating levels, including completion after prompts or verbal assistance. A reader needs that scale to understand what the endpoint represents. The measure is not equivalent to independent task completion.
The study also illustrates the distinction between documenting an outcome and reporting its result. The registry record specifies the task-success measure and provides its assessment period, but it does not report the resulting participant count. Without the result, neither the level of observed performance nor its precision can be judged. An enrollment total cannot replace an outcome estimate.
General: Statistical conclusions depend on matching the analysis to the question. A single-group assessment can describe performance under its evaluation conditions, while a comparative design is needed to estimate differences between groups under appropriate assumptions. Since this record lists no comparator, it cannot support a direct comparison of programs or approaches.
Finally, the listed secondary measures show that usability can be examined from more than one perspective: task ease, instructions, and satisfaction. But naming those measures does not reveal their findings, and the registry record does not report a multiplicity plan. Taken together, these features make the study a useful example of why readers should attend to endpoint definitions, denominators, analysis methods, and the presence or absence of posted results before drawing conclusions.
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.
The principal limitation for interpreting this registry record is that outcome results are not reported. The primary endpoint is defined, but no participant count meeting its success threshold, task-level result, or statistical estimate is available in the registry record. The secondary outcome results are also not reported. This prevents a quantitative assessment of performance and precision.
The study is single-group, with allocation listed as NA and no masking. There is no like-for-like control comparison. Any observed task performance, if reported, would describe the evaluation group and conditions rather than establish a difference attributable to the software. The record does not support conclusions about comparative usability or clinical effects.
The outcome definition combines independent completion with completion after prompts or verbal assistance. Without the distribution of individual ratings or task-specific results, the record cannot show how much performance depended on assistance. The specific tasks and detailed assessment procedures are not reported in the registry record.
The record states that one subject was withdrawn because inclusion criteria were not met and that the data were not used in the analysis. It does not report a complete participant flow, outcome-specific denominators, or how other missing or incomplete task ratings were handled. The analysis population and missing-data methods are not reported in the registry record.
Finally, the registry record lists no analyses and does not report a statistical analysis plan, a multiplicity approach, or a trial-specific sample-size justification. The adverse-event entry gives counts for 50 participants at risk, but does not report a safety timeframe; deaths are not reported. These omissions limit interpretation of both the outcome and safety entries.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Evaluation of DIDGET TM World Reports — NCT00923975.
- Registry record last updated 2024-09-23; status last verified 2024-09.
- Results first posted 2010-10-08.
- 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
This completed, single-group evaluation examined DIDGET World Reports, a web program intended to upload DIDGET meter glucose results to a secure website. The intended users included young adults, parents or guardians of young people under age 18, and healthcare professionals working with this population. Enrollment was 51; the record lists Ascensia Diabetes Care as sponsor and gives the start and primary completion as 2009-06.
The primary measure was the number of participants rated successful on specific software tasks, with success defined as ratings of 1 through 3 on a five-point scale. That definition includes completion with some assistance. The registry record does not report the primary result, secondary outcome results, a statistical analysis plan, or a multiplicity strategy. It notes one exclusion for failure to meet inclusion criteria.
The adverse-event entry lists 50 participants at risk, 0 serious adverse events, and 0 other adverse events; deaths are not reported in the registry record. With no comparator and no posted outcome results, the record describes the study question and measurements but does not quantify task performance or establish comparative or clinical effects.