Evidence map›Paper›PMID 19389820›Full record

Trial reportDiabetes care2009

Comparison of a multiple daily insulin injection regimen (basal once-daily glargine plus mealtime lispro) and continuous subcutaneous insulin infusion (lispro) in type 1 diabetes: a randomized open parallel multicenter study.

Geremia B Bolli, David Kerr, Reena Thomas, Elisabetta Torlone, Agnès Sola-Gazagnes, Ester Vitacolonna, Jean Louis Selam, Philip D Home

Erratum issuedOpen access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Diabetes care, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 23 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 4 pooled it
7.9field-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.

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

23 citing papers in PubMed, 4 syntheses or guidelines pooled it, 118 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. Pooled it
  4. Diabetes: glycaemic control in type 1.BMJ clinical evidence · 2011
    Pooled it
  5. Trial
  6. Trial
  7. Review
  8. Article
  9. Article
  10. Article
  11. A Review of Basal-Bolus Therapy Using Insulin Glargine and Insulin Lispro in the Management of Diabetes Mellitus.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2018
    Review
  12. Article
  13. Review
  14. Article
  15. Article
  16. Article
  17. Review
  18. Article
  19. Clinical experience with insulin glargine in type 1 diabetes.Diabetes technology & therapeutics · 2010
    Review
  20. Hypoglycemia in type 1 diabetes mellitus.Endocrinology and metabolism clinics of North America · 2010
    Review
4 · The record

Corrections and comments

  • Erratum issued
5 · Who and what money

Authors and funding

8 authors at 5 institutions in 3 countries.

Geremia B BolliDepartment of Internal Medicine, University of Perugia, Perugia, Italy. gbolli@unipg.it
David Kerr
Reena Thomas
Elisabetta Torlone
Agnès Sola-Gazagnes
Ester Vitacolonna
Jean Louis Selam
Philip D Home
Newcastle University · GBUniversity of Perugia · ITAssistance Publique – Hôpitaux de Paris · FRHôtel-Dieu de Paris · FRRoyal Bournemouth Hospital · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveInsulin pump therapy (continuous subcutaneous insulin infusion [CSII]) and multiple daily injections (MDIs) with insulin glargine as basal insulin and mealtime insulin lispro have not been prospectively compared in people naïve to either regimen in a multicenter study. We aimed to help close that deficiency. RESEARCH DESIGN AND

methodsPeople with type 1 diabetes on NPH-based insulin therapy were randomized to CSII or glargine-based MDI (both otherwise using lispro) and followed for 24 weeks in an equivalence design. Fifty people were correctly randomized, and 43 completed the study.

resultsTotal insulin requirement (mean +/- SD) at end point was 36.2 +/- 11.5 units/day on CSII and 42.6 +/- 15.5 units/day on MDI. Mean A1C fell similarly in the two groups (CSII -0.7 +/- 0.7%; MDI -0.6 +/- 0.8%) with a baseline-adjusted difference of -0.1% (95% CI -0.5 to 0.3). Similarly, fasting blood glucose and other preprandial, postprandial, and nighttime self-monitored plasma glucose levels did not differ between the regimens, nor did measures of plasma glucose variability. On CSII, 1,152 hypoglycemia events were recorded by 23 of 28 participants (82%) and 1,022 in the MDI group by 27 of 29 patients (93%) (all hypoglycemia differences were nonsignificant). Treatment satisfaction score increased more with CSII; however, the change in score was similar for the groups. Costs were approximately 3.9 times higher for CSII.

conclusionsIn unselected people with type 1 diabetes naïve to CSII or insulin glargine, glycemic control is no better with the more expensive CSII therapy compared with glargine-based MDI therapy.

Indexed as

AdultAge of OnsetBlood GlucoseDiabetes Mellitus, Type 1Drug Administration ScheduleFemaleGlycated HemoglobinHumansHypoglycemiaHypoglycemic AgentsInjections, SubcutaneousInsulinInsulin GlargineInsulin Infusion SystemsInsulin LisproInsulin, Long-ActingBlood GlucoseGlycated HemoglobinHypoglycemic AgentsInsulinInsulin GlargineInsulin LisproInsulin, Long-Acting

Identifiers

PMID19389820
PMCPMC2699706
OpenAlexW2142372141

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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 OpenQuestion graph.