Evidence mapPaperPMID 34758142Full record

Observational studyDiabetic medicine : a journal of the British Diabetic Association2022

Non-adjunctive continuous glucose monitoring for control of hypoglycaemia (COACH): Results of a post-approval observational study.

Stayce E Beck, Colleen Kelly, David A Price, COACH Study Group

Open access · hybridAbstract readMulticenter StudyObservational Study
In one paragraph

Observational study in Diabetic medicine : a journal of the British Diabetic Association, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 1 pooled it
2.5field-weighted citation impact, top 10% 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

14 citing papers in PubMed, 1 synthesis or guideline pooled it, 21 citations in OpenAlex.

  1. Pooled it
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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

4 authors at 2 institutions in 1 country.

Stayce E BeckDexcom, Inc., San Diego, California, USA.
Colleen KellyKelly Statistical Consulting, Carlsbad, California, USA.
David A PriceDexcom, Inc., San Diego, California, USA.
COACH Study Group
Dexcom (United States) · USStatistical Research (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivePrior to the Continuous Monitoring and Control of Hypoglycaemia (COACH) study described herein, no study had been powered to evaluate the impact of non-adjunctive RT-CGM use on the rate of debilitating moderate or severe hypoglycaemic events. RESEARCH DESIGN AND

methodsIn this 12-month observational study, adults with insulin-requiring diabetes who were new to RT-CGM participated in a 6-month control phase where insulin dosing decisions were based on self monitoring of blood glucose values, followed by a 6-month phase where decisions were based on RT-CGM data (i.e. non-adjunctive RT-CGM use); recommendations for RT-CGM use were made according to sites' usual care. The primary outcome was change in debilitating moderate (requiring second-party assistance) and severe (resulting in seizures or loss of consciousness) hypoglycaemic event frequency. Secondary outcomes included changes in HbA1c and diabetic ketoacidosis (DKA) frequency.

resultsA total of 519 participants with mean (SD) age 50.3 (16.1) years and baseline HbA1c 8.0% (1.4%) completed the study, of whom 32.8% had impaired hypoglycaemia awareness and 33.5% had type 2 diabetes (T2D). The mean (SE) per-patient frequency of hypoglycaemic events decreased by 63% from 0.08 (0.016) during the SMBG phase to 0.03 (0.010) during the RT-CGM phase (p = 0.005). HbA1c decreased during the RT-CGM phase both for participants with type 1 diabetes (T1D) and T2D and there was a trend towards larger reductions among individuals with higher baseline HbA1c.

conclusionsAmong adults with insulin-requiring diabetes, non-adjunctive use of RT-CGM data is safe, resulting in significantly fewer debilitating hypoglycaemic events than management using SMBG.

Indexed as

AdolescentAdultAgedAged, 80 and overBlood Glucose Self-MonitoringFemaleFollow-Up StudiesGlycated HemoglobinHumansHypoglycemiaMaleMiddle AgedMonitoring, AmbulatoryProspective StudiesYoung AdultGlycated HemoglobinCOACHcontinuous glucose monitoringsevere hypoglycaemia

Identifiers

PMID34758142
PMCPMC9299719
OpenAlexW3213313959

What Socratic holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.