Use of Continuous Glucose Monitors in Publicly-Insured Youth With Type 2 Diabetes - A Pilot and Feasibility Study: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Use of Continuous Glucose Monitors in Publicly-Insured Youth With Type 2 Diabetes - A Pilot and Feasibility Study (NCT05074667), a na na study. The primary outcome is Number of Participants With at Least 75% Wear Time Over 14 Days as a Measure of Sustained CGM Use.

2. Clinical Question

The study asked whether continuous glucose monitor (CGM) start and continuation could be feasible for youth with type 2 diabetes, and sought to describe glucose metrics and patient-reported outcomes. Its stated primary measure concerns sustained CGM use: the number of participants with at least 75% wear time over 14 days, assessed at months 2,3,6,9 and 12. The population for each assessment is participants with available CGM data at that timepoint.

This is a feasibility question rather than a comparison of two treatment groups. The registry describes a single group in which all participants were included in the Continuous Glucose Monitor arm. There is no separate control group in the record. The study also included patient-reported outcome questionnaires and listed outcomes relating to glucose, health status, quality of life, technology attitudes and diabetes-related problems.

The registry record does not report the observed number meeting the primary threshold at any assessment. It therefore does not establish from the posted results how often the stated wear-time criterion was met. The record also does not report results for the listed glucose or patient-reported outcomes.

3. Trial Design

This was a completed pilot and feasibility study registered as NCT05074667. The registry lists 30 participants enrolled, phase NA, allocation NA, no masking, and a single-group model. All participants were included in the Continuous Glucose Monitor arm. With no parallel comparison arm, the design describes use within one group rather than a like-for-like comparison between groups.

The study description says its purpose was to provide continued CGM access to youth with type 2 diabetes and collect descriptive information about feasibility of use. It identifies CGM start and continuation, glucose metrics, and patient-reported outcomes as areas of interest. It also describes piloting and refining a program to test the feasibility of CGM start and continuation. These statements describe the study aims; they are not reported results.

The registry lists Continuous Glucose Monitor as a device intervention and Patient Reported Outcome Questionnaires as another intervention. The primary measure concerns the count of participants reaching at least 75% wear time over 14 days. Assessments are specified for months 2,3,6,9 and 12, over the 14 days before each clinic visit, among participants with available CGM data at the respective timepoint.

The record lists Mean HbA1C, time with glucose values in the target range of 70-180 mg/dL, and multiple participant- or parent-rated questionnaire scales as secondary outcomes. It lists 10 outcome measures overall. The registry record does not report observed outcome values or analysis results for these measures.

The recorded start date is 2021-12-01, the primary completion date is 2023-06-25, and the status is COMPLETED. The registry record does not report further details of the study procedures, the sample-size justification, or a statistical analysis plan. The single-group structure is important for interpretation: observed patterns could be described within the study group, but this record does not define a concurrent control comparison.

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

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Participants with available CGM data at each respective timepoint

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.

6. Primary Endpoint

The registry lists the primary outcome as Number of Participants With at Least 75% Wear Time Over 14 Days as a Measure of Sustained CGM Use, measured over months 2,3,6,9 and 12 (assessed over the 14 days prior to each clinic visit).

The primary endpoint is the number of participants with at least 75% CGM wear time over 14 days. It is assessed at months 2,3,6,9 and 12, using the 14 days before each clinic visit. The endpoint is intended to describe sustained device use at repeated follow-up assessments. Its focus is whether participants have enough recorded wear time to meet the stated threshold, rather than a comparison of glucose values between randomized groups.

A threshold-based measure can make a practical feasibility target explicit: participants either meet the wear-time criterion for an assessment or they do not. The endpoint is recorded as a count of participants, not as a continuous measure of wear time. The count alone is most informative when its applicable denominator is also clear. The record specifies that the relevant population at each timepoint is participants with available CGM data, but does not report the number with available data or the observed count meeting the criterion at each assessment.

As a general statistical point, repeated assessments can describe whether the target is reached at different stages of follow-up, but interpretation depends on who contributes data at each stage and how unavailable observations are handled. Those details matter because availability may differ across timepoints. The registry record does not report an analysis of changes over time or the rules used to handle unavailable CGM data.

The primary outcome title defines the threshold and assessment window, but the posted results do not report endpoint values. Thus, the endpoint’s purpose is clear, while the extent to which participants met it is not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry describes one group and a primary outcome recorded as a count of participants. The endpoint is whether a participant has at least 75% wear time over a 14-day period, assessed at months 2,3,6,9 and 12. The record defines the assessment windows but does not give the observed counts or the number of participants with available CGM data at each one.

What does a count measure?

A count records how many participants meet a specified condition. In this study, the condition is the stated wear-time threshold during the stated period. A count is not interchangeable with a percentage: to express the count as a proportion, the denominator must be defined. The registry identifies the relevant population as participants with available CGM data at each timepoint, but the denominator at each assessment is not reported in the registry record. It would therefore be inappropriate to infer a proportion from the enrollment figure alone.

In general, an estimate based on a count can be accompanied by an interval describing statistical uncertainty. The interval’s method and assumptions should be reported, and the interval should be interpreted in light of the study design and the availability of observations. The registry record does not report an interval or an analysis method for the primary endpoint.

Why does the single-group design matter?

In a single-group study, outcome descriptions characterize participants in that group. A comparison between an intervention group and a control group requires observations from both groups and a defined contrast. This registry record describes all participants in the Continuous Glucose Monitor arm and does not list a separate comparator arm. It therefore does not support a randomized between-group treatment-effect estimate.

General statistical explanation: random allocation, when used, can help make comparison groups similar on average with respect to measured and unmeasured characteristics. This study’s allocation is listed as NA, so a randomized comparison is not part of the recorded design. A single-group result may still be useful for describing feasibility, but it cannot isolate the effect of CGM from other influences using a concurrent control contrast.

What is the role of the repeated assessments?

The endpoint is scheduled at multiple months, with each assessment referring to the 14 days before a clinic visit. Repeated observations can provide descriptions at different points in follow-up. They may also raise questions about whether the same participants contribute observations each time, whether data are missing, and whether within-participant dependence is handled in an analysis. The registry record does not report methods for comparing timepoints, accounting for repeated observations, or handling missing data.

General statistical explanation: observations from the same person are often related rather than independent. Analyses that treat related observations as independent can misrepresent uncertainty. A repeated-measures method may account for that relationship, but the suitable method depends on the estimand, data structure, and analysis plan. No such plan is reported in the registry record.

What do the secondary outcomes add?

The registry lists Mean HbA1C and time with glucose values in the target range of 70-180 mg/dL, alongside PROMIS Global Health, PedsQL 3.2, Diabetes Technology Attitudes, and Problem Areas in Diabetes-Teen Version scales. These measures cover glucose metrics and participant- or parent-reported outcomes. The record lists 10 outcome measures in total, but does not report estimates, uncertainty intervals, or analysis results for them.

Different outcome types call for different summaries. A continuous measure such as a scale score is often described using a measure of location and variability, while a count or proportion needs an appropriate denominator and uncertainty estimate. These are general principles; the registry record does not specify the summaries or statistical models used for the listed secondary outcomes.

How should the planning illustration be read?

The record describes planning assumptions involving a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect set at a stated fraction of an observed effect. The illustration is not the study’s own design justification. It also does not reflect the recorded single-group design, which has no two-arm comparison. Planning calculations describe hypothetical design scenarios; they are not observed power and do not demonstrate that a study has or lacks a particular probability of detecting an effect.

General statistical explanation: power is a property of a design under specified assumptions about the effect, variability, sample size, and analysis. It is not a measure of whether a reported result is true. Calculating power after observing results from the same study does not replace reporting estimates and their uncertainty. No study-specific sample-size justification or statistical analysis plan is reported in the registry record.

The registry lists zero analysis entries. That registry listing should be distinguished from a claim about whether investigators performed analyses outside the registry. For readers, the key limitation is that no outcome estimates or analysis methods are available in the record to assess.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists 10 outcome measures, including the primary sustained-use endpoint and multiple glucose and patient-reported outcomes. It does not report a multiplicity plan, such as whether one outcome was designated as the sole basis for formal inference, whether secondary outcomes were considered descriptive, or whether any adjustment for multiple testing was planned. Without such information, the interpretation of several statistical tests, if performed, cannot be assessed from the registry record.

The record lists zero analysis entries and does not report outcome estimates, standard errors, confidence intervals, p-values, or analysis methods. It also does not report whether any interim analyses were planned or conducted. No assumptions about interim monitoring or statistical decision rules can be made from the available record.

For the primary endpoint, the defined analysis population consists of participants with available CGM data at each respective timepoint. The number with available data at each assessment is not reported in the registry record. The record does not explain how participants without available CGM data were handled, whether missing observations were excluded, or whether any imputation or sensitivity analysis was used. It also does not specify whether availability was considered in interpreting sustained use.

General statistical explanation: missing observations can affect both the amount of information available and the meaning of an estimate. If data availability is related to device use or participant experience, an analysis restricted to available observations may describe a selected subset. That is a general concern, not a claim about why data might be unavailable in this study. The registry record does not provide information to evaluate the pattern or consequences of missing data.

The record does not describe analysis populations beyond the timepoint-specific population defined for the primary endpoint. It does not state whether all enrolled participants were included in analyses of secondary outcomes. Those details are not reported in the registry record, so the denominator and handling of missingness should not be assumed.

11. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

The registry lists 30 participants at risk for serious adverse events and zero participants affected by serious adverse events in the Continuous Glucose Monitor group. It also lists 30 at risk for other adverse events and zero affected by other adverse events. Deaths are listed separately, with one death recorded.

These are registry counts, not a comparison between groups. The study has a single group, and no comparator is listed. The record does not give further details about the death, including its timing, cause, or relationship to the device or study. It also does not report additional descriptive information about the safety events. No causal interpretation can be made from the counts alone.

General statistical explanation: a count of zero recorded events does not establish that an event is impossible or that risk is absent. The precision of an event estimate depends on the number observed and the amount of follow-up, among other factors. The registry record does not provide an uncertainty interval or enough detail to derive one for these safety counts. The one recorded death should be read as a separate listed count, without assuming whether it was related to study participation.

12. What the Result Does, and Does Not, Mean

The record establishes that the study was designed as a pilot and feasibility study of CGM use among publicly insured youth with type 2 diabetes. It describes a single group, 30 enrolled participants, a repeated threshold-based measure of CGM wear time, and a set of secondary glucose and patient-reported outcomes. It also records the study as completed, with a primary completion date of 2023-06-25.

The record does not report the observed primary endpoint counts, the number of participants with available CGM data at each timepoint, or results for the secondary outcomes. It therefore does not show how many participants met the wear-time threshold, how glucose measures changed or were distributed, or what questionnaire scores were observed. A result should not be inferred from the stated study aims or outcome definitions.

The design also limits what any single-group description could establish. Without a separate comparison group, the record does not provide a controlled estimate of differences attributable to CGM. A descriptive feasibility measure can address whether use was observed in the enrolled group, but it does not on its own establish a causal effect or predict the experience of every youth with type 2 diabetes.

General statistical explanation: an estimate is more informative when presented with its denominator, uncertainty, and analysis population. Here, the primary endpoint population is defined by available CGM data at each timepoint, but the corresponding denominators and estimates are not reported in the registry record. Those omissions prevent assessment of the precision of the primary measure and the extent to which its observed data represent all enrolled participants.

The safety listing reports zero participants affected by serious adverse events, zero affected by other adverse events, and one death. The record does not describe the death further, so its cause or relationship to the study cannot be inferred. These counts should be read as registry entries rather than as evidence of causal attribution.

In short, the posted information describes the question and design but does not provide the outcome data needed to judge the observed feasibility findings. This absence of reported results is not evidence that the intended outcomes were either achieved or not achieved.

13. Why This Trial Matters Statistically

Feasibility studies address questions that are distinct from comparative efficacy questions. For CGM use in youth with type 2 diabetes, the registry’s primary measure focuses on reaching a defined wear-time threshold over a specified period. Such an endpoint can make an aspect of device use explicit and can inform the design of later research. The study description also identifies the aim of piloting and refining a program for CGM start and continuation.

Statistically, the endpoint definition alone is not enough to understand how feasible use was in practice. The observed count, its denominator at each assessment, and the handling of unavailable data are needed to interpret the result. The registry record identifies the population as participants with available CGM data but does not report the timepoint-specific counts or denominators. This illustrates why reporting the analysis population alongside a feasibility outcome matters.

The study’s single-group structure is another important statistical feature. It is suited to describing experience within the enrolled group, but it does not create a controlled contrast. This distinction helps readers avoid interpreting a feasibility measure as a comparative treatment effect. The record lists both glucose metrics and patient-reported outcomes, yet their results and analysis methods are not reported.

The registry also lists 10 outcome measures and zero analysis entries. Multiple outcomes can provide a broad account of feasibility and participant experience, but interpretation depends on which outcomes are primary, how each is summarized, and whether multiple statistical tests are interpreted as confirmatory or descriptive. Those analysis details are not reported in the registry record.

The study is statistically informative as a clearly framed feasibility question, while its registry record leaves key results and methods unspecified. This difference between a defined question and reported evidence is central when assessing what a clinical trial record 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.

The most direct limitation for interpretation is that outcome results are not reported in the registry record. Although the primary endpoint and secondary outcomes are listed, the record does not provide observed values, uncertainty intervals, or analysis results. The feasibility question is therefore identifiable, but its observed answer cannot be assessed from the posted record.

The primary measure is restricted at each timepoint to participants with available CGM data. Timepoint-specific denominators are not reported. The record also does not explain how unavailable CGM data were handled or whether the same participants contributed to every assessment. This makes it impossible to assess from the record whether the endpoint counts represent all enrolled participants or a subset at each timepoint.

The study has one group and no recorded comparator. This precludes a concurrent between-group comparison in the registry design and limits conclusions to descriptions of the study group. The record lists allocation as NA and masking as NONE. It does not report additional information about participant characteristics, adherence procedures, or other factors that could help readers assess how broadly the observations might apply.

Although the study description identifies the population as publicly insured youth with type 2 diabetes and refers to ages 4 years and older, further demographic or clinical detail is not reported in the registry record. The record does not report a study-specific sample-size justification or statistical analysis plan. It also does not describe methods for multiplicity, missing data, repeated observations, or secondary-outcome analysis.

These limitations concern what can be understood from the registry record; they should not be taken as proof that unreported procedures or analyses did not occur. The record simply does not provide those details. The safety information is also limited: one death is listed, without information on timing, cause, or relationship to the study.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Use of Continuous Glucose Monitors in Publicly-Insured Youth With Type 2 Diabetes - A Pilot and Feasibility Study — NCT05074667.
• Registry record last updated 2024-07-31; status last verified 2024-07.
• Results first posted 2024-07-31.
• 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.

18. Record Summary

NCT05074667 is a completed, single-group pilot and feasibility study of continuous glucose monitor use in publicly insured youth with type 2 diabetes. The registry lists 30 participants enrolled, no masking, and allocation NA. The recorded start date is 2021-12-01, and the primary completion date is 2023-06-25.

The primary outcome is the number of participants with at least 75% wear time over 14 days, assessed at months 2,3,6,9 and 12 among participants with available CGM data at each timepoint. The record lists 10 outcome measures, including glucose and patient-reported outcomes, but does not report observed outcome results or analysis entries.

The safety listing records zero participants affected by serious adverse events, zero affected by other adverse events, and one death. The record does not provide further details about the death. A study-specific sample-size justification, statistical analysis plan, and further missing-data methods are not reported in the registry record.