Evidence map›Paper›PMID 32718934›Full record

Trial reportBMJ open diabetes research & care2020

Use of a diabetes-specific nutritional shake to replace a daily breakfast and afternoon snack improves glycemic responses assessed by continuous glucose monitoring in people with type 2 diabetes: a randomized clinical pilot study.

Vikkie A Mustad, Refaat A Hegazi, Deborah S Hustead, Erwin S Budiman, Ricardo Rueda, Kevin Maki, Margaret Powers, Jeffrey I Mechanick, Richard M Bergenstal, Osama Hamdy

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMJ open diabetes research & care, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04230889 (A Pilot Study to Evaluate Glucose Control in Patients With Type 2 Diabetes), which is not on this map. Cited by 20 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 1 pooled it
1.9field-weighted citation impact, top 14% 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.

NCT04230889 nacompletednot on this map

A Pilot Study to Evaluate Glucose Control in Patients With Type 2 Diabetes

TypeinterventionalSponsorAbbott NutritionRan2017 to 2018Enrolled125ConditionsGlycemic ControlArmsUsual Diet Group, Group 1 Nutritional Shake, Group 2 Nutritional Shake
3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 1 synthesis or guideline pooled it, 27 citations in OpenAlex.

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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

10 authors at 7 institutions in 6 countries.

Vikkie A MustadResearch and Development Department, Abbott Nutrition, Columbus, Ohio, USA.ORCID 0000-0002-5608-1896
Refaat A HegaziResearch and Development Department, Abbott Nutrition, Columbus, Ohio, USA Refaat.Hegazi@abbott.com.ORCID 0000-0001-5564-0222
Deborah S HusteadResearch and Development Department, Abbott Nutrition, Columbus, Ohio, USA.
Erwin S BudimanResearch and Development Department, Abbott Diabetes Care, Alameda, California, USA.
Ricardo RuedaResearch and Development Department, Abbott Nutrition, Granada, Spain.
Kevin MakiPresident and Chief Scientist, MB Clinical Research, Boca Raton, Florida, USA.
Margaret PowersInternational Diabetes Center at Park Nicollet, St. Louis Park, Minnesota, USA.
Jeffrey I MechanickProfessor of Medicine and Medical Director, Kravis Center for Cardiovascular Health at Mount Sinai Heart, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
Richard M BergenstalInternational Diabetes Center at Park Nicollet, St. Louis Park, Minnesota, USA.
Osama HamdyObesity Clinical Program, Director of Inpatient Diabetes Program, Joslin Diabetes Center, Boston, Massachusetts, USA.
Abbott (United States) · USPark Nicollet Clinic · USAbbott (Canada) · CAIcahn School of Medicine at Mount Sinai · USJoslin Diabetes Center · USMansoura University · EGOffice of the Chief Scientist · IL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThis pilot study evaluated the impact of a diabetes-specific nutritional shake (DSNS) used twice daily by people with type 2 diabetes (T2D) on glycemic response assessed by continuous glucose monitoring (CGM). RESEARCH DESIGN AND

methodsAdults (n=81) with T2D managed by oral medications were studied in a randomized, open-label, three-group parallel study design. The study was conducted in two phases over 14 days: Baseline (days 1-6), during which study participants consumed their habitual self-selected diets (SSD), followed by the Intervention (days 7-14), during which participants were randomized as follows: (1) SSD group received no study product (n=32); (2) DSNS breakfast/afternoon snack (Bkfst/AS) group consumed one DSNS as a breakfast meal replacement and a second to replace their mid-afternoon snack (n=24); (3) DSNS breakfast/prebed snack (Bkfst/PBS) group consumed one DSNS as a breakfast meal replacement and added a second as a prebed snack (n=25). Glucose was assessed by CGM throughout the study. Additionally, participants were asked about snacking behaviors, cravings, and other questions related to the use of DSNS as meal replacements and snacks.

resultsAll groups reduced their postprandial glycemic response (positive area under the curve (pAUC, mg/min*dL

conclusionsUse of DSNS to replace breakfast and as an afternoon snack improves both glycemic control and behavioral factors related to dietary management of diabetes. TRAIL REGISTRATION NUMBER: NCT04230889.

Indexed as

Diabetes Mellitus, Type 2SnacksAdultBlood GlucoseBlood Glucose Self-MonitoringBreakfastHumansPilot ProjectsBlood Glucosecontinuous glucose monitoringnutrition interventionself-managementtype 2 diabetes

Identifiers

PMID32718934
PMCPMC7389484
OpenAlexW3045750658

What Socratic holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

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.