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Impact of Active Versus Usual Algorithmic Titration of Basal Insulin and Point-of-Care Versus Laboratory Measurement of HbA1c on Glycemic Control in Patients With Type 2 Diabetes

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Kennedy, Laurence, Herman, William H., Strange, Poul, Harris, Anthony, for the GOAL A1C Team·2006·Diabetes Care
DOI 10.2337/diacare.29.01.06.dc05-1058
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Abstract

OBJECTIVE—The objective of this study was to assess the impact of active versus usual monitoring of algorithmic insulin titration and point-of-care (POC) versus laboratory HbA1c (A1C) measurement on glycemic control in primary care. RESEARCH DESIGN AND METHODS—The Glycemic Optimization with Algorithms and Labs at Point of Care (GOAL A1C) study was a 24-week, randomized, parallel-group, four-arm, open-label study of 7,893 adults with type 2 diabetes uncontrolled by oral antidiabetic agents and requiring insulin. Patients were randomly assigned by investigators from 2,164 sites in the U.S. to insulin glargine with either 1) usual (no unsolicited contact between visits) insulin titration using a simple algorithm with laboratory A1C testing, 2) usual titration with POC A1C testing, 3) active (weekly monitored) titration with laboratory A1C testing, or 4) active titration with POC A1C testing. Outcome measures included a change in A1C and fasting self-monitoring of blood glucose (SMBG) levels, percentage of patients achieving A1C <7.0%, and hypoglycemia frequency. RESULTS—Significant A1C and SMBG reductions were observed in all arms (P < 0.0001). Compared with usual insulin titration, active titration achieved greater A1C reduction (1.5 vs. 1.3%; P < 0.0001), SMBG reduction (88 vs. 79 mg/dl; P < 0.0001), and proportion of patients achieving A1C <7.0% (38 vs. 30%; P < 0.0001). Among patients receiving active titration, POC A1C testing was associated with an increase in the proportion achieving an A1C <7.0% (41% for POC vs. 36% for laboratory; P < 0.0001). Hypoglycemia rates were low (usual vs. active groups: 3.7 vs. 6.0 all confirmed episodes/patient-year [P < 0.001]; 0.09 vs. 0.14 severe episodes/patient-year [NS]). CONCLUSIONS—In a predominantly primary care setting, addition of insulin glargine using a simple algorithm achieved significant improvements in glycemic control in patients with type 2 diabetes in all four study arms. Active titration resulted in significant incremental improvements in glycemic control, and, among patients receiving active titration, POC A1C testing resulted in a greater portion achieving A1C <7.0%.

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  • There is some evidence that immediate feedback of HbA1c test results to patients at the time of the clinic visit improves long-term glycemic control.

    “There is some evidence to suggest that immediate feedback of HbA 1c test results to patients at the time of the clinic visit improves long-term glycemic control (369,370).”

    From Guidelines and Recommendations for Laboratory Analysis in the Diagnosis and Management of Diabetes Mellitus (2023) · cites this paper as [370]

    The Secondary outcomes section reports that point-of-care A1C testing increased the proportion reaching the A1C target in a subgroup with baseline A1C above 10%. But the discussion says immediate results generally added no glycemic benefit beyond active insulin titration. The study measured outcomes over six months, so it does not establish a general improvement in long-term control. (LLM, conf=0.86)

    Experimental — accuracy not yet measured

  • There is some evidence that giving patients their HbA1c results during the clinic visit improves long-term glycemic control.

    “Some evidence suggests that immediate feedback of HbA 1c test results to patients at the time of the clinic visit leads to an improvement in their long-term glycemic control (249,250).”

    From Guidelines and recommendations for laboratory analysis in the diagnosis and management of diabetes mellitus (2011) · cites this paper as [250]

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Research works printed but not linked: 2

  1. [11]11. Hosmer DW Jr, Lemeshow S: Applied Lo- gistic Regression. New York, Wiley, 1989
  2. [16]16. Kennedy L, Herman WH: Glycated he- moglobin assessment in clinical practice: comparison of the A1cNow ™ point-of- care device with central laboratory testing (GOAL A1C study). Diabetes Technol Ther In press

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Related

Authors
Kennedy, L., Herman, W. H., Strange, P., Harris, A., & for the GOAL A1C Team
Affiliations
  • University of Florida Health (US)
  • Michigan Medicine (US)
  • Sanofi (United States) (US)
ORCID
Venue
Diabetes Care
Publisher
American Diabetes Association
Published
2006-01-01
Volume
29
Issue
1
Pages
1-8
ISSN
  • 0149-5992 (ISSN-L)
  • 1935-5548
DOI
10.2337/diacare.29.01.06.dc05-1058
OpenAlex
W2123177035
Semantic Scholar
79a91e161e5558e1ed386179918231b52e1af634
Cited by
189
References
17
Citations by year
2025: 2 · 2024: 2 · 2023: 7 · 2022: 3 · 2021: 2 · 2020: 3 · 2019: 9 · 2018: 7 · 2017: 3 · 2016: 7 · 2015: 9 · 2014: 9 · 2013: 7 · 2012: 12
FWCI
18.11
Type
journal article
Language
en
Open access
Locations
  • Diabetes Care (publishedVersion)
  • PubMed (publishedVersion)
Funders
  • American Diabetes Association
  • Eli Lilly and Company
  • Pfizer
  • GlaxoSmithKline
  • Sanofi
  • Novo Nordisk
Topics
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Education
Keywords
type 2 diabetes, basal insulin, insulin dose adjustment, glycemic control, insulin glargine, self-monitoring of blood glucose, hypoglycemia, primary care, severe hypoglycemia
MeSH terms
Administration, Oral, Adult, Aged, Algorithms, Blood Glucose, Diabetes Mellitus, Type 2, Female, Glycated Hemoglobin, Humans, Hypoglycemic Agents, Male, Middle Aged, Blood Glucose Self-Monitoring, Body Mass Index, Point-of-Care Systems, Racial Groups

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