Evidence mapPaperPMID 36864014Full record

Trial reportEndocrinology, diabetes & metabolism2023

Assessing non-adjunctive CGM safety at home and in new markets (ANSHIN).

Christy Chao, Sarah B Andrade, Simon Bergford, Peter Calhoun, John B Welsh, Tomas C Walker, ANSHIN Study Group

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Endocrinology, diabetes & metabolism, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
1.0field-weighted citation impact, top 23% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 5 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Review
  4. Review
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 2 institutions in 1 country.

Christy ChaoDexcom, Inc., San Diego, California, USA.
Sarah B AndradeDexcom, Inc., San Diego, California, USA.ORCID 0000-0003-4646-433X
Simon BergfordJaeb Center for Health Research, Tampa, Florida, USA.
Peter CalhounJaeb Center for Health Research, Tampa, Florida, USA.
John B WelshDexcom, Inc., San Diego, California, USA.
Tomas C WalkerDexcom, Inc., San Diego, California, USA.
ANSHIN Study Group
Dexcom (United States) · USJaeb Center for Health Research · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionContinuous glucose monitoring (CGM) can guide treatment for people with type 1 (T1D) and type 2 diabetes (T2D). The ANSHIN study assessed the impact of non-adjunctive CGM use in adults with diabetes using intensive insulin therapy (IIT). MATERIALS AND

methodsThis single-arm, prospective, interventional study enrolled adults with T1D or T2D who had not used CGM in the prior 6 months. Participants wore blinded CGMs (Dexcom G6) during a 20-day run-in phase, with treatment based on fingerstick glucose values, followed by a 16-week intervention phase and then a randomized 12-week extension phase with treatment based on CGM values. The primary outcome was change in HbA1c. Secondary outcomes were CGM metrics. Safety endpoints were the number of severe hypoglycaemic (SH) and diabetic ketoacidosis (DKA) events.

resultsOf the 77 adults enrolled, 63 completed the study. Those enrolled had mean (SD) baseline HbA1c of 9.8% (1.9%), 36% had T1D, and 44% were ≥65 years old. Mean HbA1c decreased by 1.3, 1.0 and 1.0 percentage points for participants with T1D, T2D or age ≥65, respectively (p < .001 for each). CGM-based metrics including time in range also improved significantly. SH events decreased from the run-in period (67.3 per 100 person-years) to the intervention period (17.0 per 100 person-years). Three DKA events unrelated to CGM use occurred during the total intervention period.

conclusionsNon-adjunctive use of the Dexcom G6 CGM system improved glycaemic control and was safe for adults using IIT.

Indexed as

Diabetes Mellitus, Type 1Diabetes Mellitus, Type 2Diabetic KetoacidosisAdultAgedBlood GlucoseBlood Glucose Self-MonitoringGlycated HemoglobinHumansHypoglycemic AgentsInsulinInsulin, Regular, HumanProspective StudiesBlood GlucoseGlycated HemoglobinHypoglycemic AgentsInsulinInsulin, Regular, Humanblood glucose self-monitoringglycaemic controlglycated haemoglobin

Identifiers

PMID36864014
PMCPMC10164430
OpenAlexW4322761078

What Socratic holds

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LicenceCC BY
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.