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N/A (device / behavioral)CompletedNCT02912728

SENCE: CGM and family support in young children

What this study tests

A historical randomized trial in 143 children compared Dexcom G5 CGM with or without family behavioral support against fingerstick monitoring. The primary time-in-range comparison was not statistically significant; time below range decreased with CGM. Registry results first posted in September 2026 differ from the original paper on completion and some safety reporting.

Editorial review: . 16 September review-note archive (earlier notes may not cover later changes).

Registry checked: 2026-09-17. Registry’s own update: 2026-09-16.

Most recent recorded citation date: 2020-12-17. Only explicit date metadata is included; an undated citation may be newer. This does not mean every claim was reviewed on that date.

Trial status, labels and access can change between reviews. Review coverage and open work · How to read the evidence

Full sources ↓Full discussion ↓Report an issue →

Evidence at a glance

Who can enter the study?
Children aged 2 to under 8 with type 1 diabetes, screening HbA1c 7.0 to under 10.0%, and no real-time CGM use in the prior 30 days. The paper reports that minimum diabetes duration and stable insulin-regimen requirements were relaxed during recruitment; the current registry retains the earlier requirements. This completed study is not recruiting. Registered eligibility ↗Enrollment criteria describe who may enter. They do not establish who was analyzed or the denominator for a reported result.
Reported benefit and results
The primary time-in-range comparisons did not reach statistical significance. Both CGM groups spent less time below 70 mg/dL than the fingerstick group. Family support improved specific caregiver-reported burden and hypoglycemia-fear measures. Small clinical event counts and paper/registry reporting discrepancies limit safety interpretation.Read the result sources and their limitations →
Important harms
Read the reported results, safety discussion and original sources. A separate harms summary is not available; this does not establish safety.
Research access and approval
Study regions: United States. A trial listing does not establish product approval or current recruitment at a particular site. Check the study’s current entry requirements.
What remains uncertain?
Read the 16 September review-note archive and current review coverage. Later changes and new records may not appear in the earlier notes. Planned endpoints and completion dates are not results.

Research status alone does not establish approval, clinical benefit or local availability.

Primary endpoints

  • Percentage of time in glucose range 70–180 mg/dL, pooled across follow-up visits through 26 weeks

The full picture

SENCE randomized 143 children aged 2 to under 8 at 14 US centers: 50 to CGM plus family behavioral support, 44 to CGM with standardized education alone, and 49 to fingerstick monitoring. Both CGM groups used Dexcom G5, with two daily calibrations; this was not an automated insulin delivery study or a trial of current G7 devices. The fingerstick group wore masked G4 sensors during measurement periods.1

The primary endpoint was not met. Adjusted differences in time within 70–180 mg/dL were 3.2 percentage points for CGM plus support versus fingersticks (95% CI −0.5 to 7.0), 0.5 points for standard CGM versus fingersticks (−2.6 to 3.6), and 2.7 points for CGM plus support versus standard CGM (−0.6 to 6.1). All intervals included zero. The favorable later-visit-only analysis was exploratory and post hoc, not the primary result.1

Secondary outcomes were different. Time below 70 mg/dL decreased from 5.2% to 2.6% with CGM plus support and from 5.8% to 2.5% with standard CGM, versus 5.4% to 5.8% with fingersticks. Caregiver diabetes burden and hypoglycemia fear improved with family support; general well-being and family-impact scores did not show significant group differences. Analyses adjusted pairwise comparisons but not the number of different secondary outcomes.1

Population counts depend on the analysis. The paper reports 137 children completing six months (48, 43 and 46 by group), and follow-up sensor data for 49, 44 and 45. Its intention-to-treat analysis included all randomized participants. The registry flow instead labels all 143 as completing and gives primary-outcome denominators of 50, 44 and 49. These are not interchangeable counts, and the reporting difference remains unresolved.12

Safety needs both sources. The paper reports severe hypoglycemia events in 0, 1 and 5 participants, and DKA in 1, 1 and 0, respectively. The registry serious-event table instead lists severe hypoglycemia in 0, 0 and 5 and DKA in 0, 1 and 0. Different classification or reporting may contribute, but this review did not establish the reason. The paper also reports 81 device issues, including two retained sensor tips that resolved without intervention. These small counts do not establish that CGM prevents all severe events.12

Why this older trial is included. The original results were published online in December 2020; structured registry results first appeared on 16 September 2026. The study illustrates that reducing low-glucose exposure and supporting caregivers can matter even when the primary time-in-range result is inconclusive. It does not compare modern CGM brands or justify changing their accuracy scores. Helmsley funded the study; Dexcom supplied devices, and some investigators disclosed industry relationships. Supplementary files were not separately retrieved in this review.12

References

  1. SENCE Study Group. Original full trial report, Methods, Tables 1–3, Safety Outcomes and Funding. https://pmc.ncbi.nlm.nih.gov/articles/PMC9162100/ ↩ ↩2 ↩3 ↩4 ↩5 ↩6

  2. ClinicalTrials.gov. NCT02912728, protocol and posted results, checked 17 September 2026. https://clinicaltrials.gov/study/NCT02912728 ↩ ↩2 ↩3

Sources

  1. [1]ClinicalTrials.gov: SENCE (NCT02912728), including posted results · Trial registry — Results first posted 16 September 2026. Participant flow, outcome denominators and serious-event categories differ from the original paper; these differences are not resolved here.
  2. [2]SENCE Study Group: A Randomized Clinical Trial Assessing CGM Use With Standardized Education With or Without a Family Behavioral Intervention · Peer-reviewed study · 2020-12-17 — Original full paper, Methods, Tables 1–3, Safety Outcomes and Funding. Published online in December 2020 and in the February 2021 issue; not a new September 2026 clinical result.