Evidence map›Paper›PMID 18364392›Full record

Trial reportDiabetes care2008

Adjust to target in type 2 diabetes: comparison of a simple algorithm with carbohydrate counting for adjustment of mealtime insulin glulisine.

Richard M Bergenstal, Mary Johnson, Margaret A Powers, Alan Wynne, Aleksandra Vlajnic, Priscilla Hollander, Marc Rendell

Registry-linked trialOpen access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Diabetes care, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01170208 (Open-Label, Uncontrolled, Single-Arm, Single-Center, 16-Week Study Assessing Efficacy and Safety of Frequently Modified Insulin Therapy Using Dosage Recommending Device Software in 3-Groups of Subjects With Diabetes), which is not on this map. Cited by 48 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
48citing papers in PubMed, 4 pooled it
8.5field-weighted citation impact, top 2% 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.

NCT01170208 nacompletednot on this mapstarted 2010, after this paper: background citation

Open-Label, Uncontrolled, Single-Arm, Single-Center, 16-Week Study Assessing Efficacy and Safety of Frequently Modified Insulin Therapy Using Dosage Recommending Device Software in 3-Groups of Subjects With Diabetes

TypeinterventionalSponsorHealthPartners InstituteRan2010 to 2011Enrolled46ConditionsDiabetes, InsulinArmsinsulin dose software
3 · Its place in the literature

Who cites it

48 citing papers in PubMed, 4 syntheses or guidelines pooled it, 181 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors at 5 institutions in 1 country.

Richard M BergenstalInternational Diabetes Center at Park Nicollet, Minneapolis, Minnesota, USA. richard.bergenstal@parknicollet.com
Mary Johnson
Margaret A Powers
Alan Wynne
Aleksandra Vlajnic
Priscilla Hollander
Marc Rendell
Park Nicollet Clinic · USBaylor University Medical Center · USColmery-O'Neil VA Medical Center · USCreighton University · USSanofi (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveCarbohydrate counting is an effective approach to mealtime insulin adjustment in type 1 diabetes but has not been rigorously assessed in type 2 diabetes. We sought to compare an insulin-to-carbohydrate ratio with a simple algorithm for adjusting the dose of prandial insulin glusiline. RESEARCH AND DESIGN

methodsThis 24-week, multicenter, randomized, controlled study compared two algorithms for adjusting mealtime (glulisine) insulin along with a standard algorithm for adjusting background (glargine) insulin in 273 intent-to-treat patients with type 2 diabetes. Glulisine and glargine were adjusted weekly in both groups based on self-monitored blood glucose (SMBG) results from the previous week. The simple algorithm group was provided set doses of glulisine to take before each meal. The carbohydrate counting (carb count) group was provided an insulin-to-carbohydrate ratio to use for each meal and adjusted their glulisine dose based on the amount of carbohydrate consumed.

resultsA1C levels at week 24 were 6.70% (simple algorithm) and 6.54% (carb count). The respective mean A1C changes from baseline to 24 weeks were -1.46 and -1.59% (P = 0.24). A1C <7.0% was achieved by 73.2% (simple algorithm) and 69.2% (carb count) (P = 0.70) of subjects; respective values for A1C <6.5% were 44.3 and 49.5% (P = 0.28). The total daily dose of insulin was lower, and there was a trend toward less weight gain in carb count group patients. Severe hypoglycemia rates were low and equal in the two groups.

conclusionsWeekly basal-bolus insulin adjustments based on premeal and bedtime glucose patterns resulted in significant reductions in A1C. Having two effective approaches to delivering and adjusting rapid-acting mealtime insulin may increase physicians' and patients' willingness to advance therapy to a basal-bolus insulin regimen.

Indexed as

Dietary CarbohydratesAdultAgedAlgorithmsBlood GlucoseDiabetes Mellitus, Type 2Dose-Response Relationship, DrugDrug Administration ScheduleEatingFemaleGlycated HemoglobinHumansHypoglycemic AgentsInsulinInsulin GlargineInsulin, Long-ActingBlood GlucoseDietary CarbohydratesGlycated HemoglobinHypoglycemic AgentsInsulinInsulin Glargineinsulin glulisineInsulin, Long-ActingMetformin

Identifiers

PMID18364392
PMCPMC2453649
OpenAlexW2163346784

What OpenQuestion holds

Texttitle and abstract
LicenceCC BY-NC-ND
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 OpenQuestion graph.