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Cox DJ, Oser T, Moncrief M, et al. Long-term follow-up of a randomized clinical trial comparing glycemic excursion minimization (GEM) to weight loss (WL) in the management of type 2 diabetes. BMJ Open Diabetes Res Care. 2021;9(2)doi: 10.1136/bmjdrc-2021-002403.
Cox, D. J., Oser, T., Moncrief, M., Conaway, M., & McCall, A. (2021). Long-term follow-up of a randomized clinical trial comparing glycemic excursion minimization (GEM) to weight loss (WL) in the management of type 2 diabetes. BMJ open diabetes research & care, 9(2), . https://doi.org/10.1136/bmjdrc-2021-002403
Cox, Daniel J, et al. "Long-term follow-up of a randomized clinical trial comparing glycemic excursion minimization (GEM) to weight loss (WL) in the management of type 2 diabetes." BMJ open diabetes research & care vol. 9,2 (2021). doi: https://doi.org/10.1136/bmjdrc-2021-002403
Cox DJ, Oser T, Moncrief M, Conaway M, McCall A. Long-term follow-up of a randomized clinical trial comparing glycemic excursion minimization (GEM) to weight loss (WL) in the management of type 2 diabetes. BMJ Open Diabetes Res Care. 2021 Nov;9(2). doi: 10.1136/bmjdrc-2021-002403. PMID: 34845062; PMCID: PMC8634632.
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BMJ Open Diabetes Res Care. 2021 Nov;9(2). doi: 10.1136/bmjdrc-2021-002403.

Long-term follow-up of a randomized clinical trial comparing glycemic excursion minimization (GEM) to weight loss (WL) in the management of type 2 diabetes.

BMJ open diabetes research & care

Daniel J Cox, Tamara Oser, Matthew Moncrief, Mark Conaway, Anthony McCall

Affiliations

  1. Psychiatry, University of Virginia, Charlottesville, Virginia, USA [email protected].
  2. Family Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.
  3. Center for Behavioral Medicine Research, University of Virginia School of Medicine, Charlottesville, Virginia, USA.
  4. Department of Public Health Sciences, University of Virginia School of Medicine, Charlottesville, Virginia, USA.
  5. Medicine, University of Virginia, Charlottesville, Virginia, USA.

PMID: 34845062 PMCID: PMC8634632 DOI: 10.1136/bmjdrc-2021-002403

Abstract

INTRODUCTION: We previously reported the physical, psychological and behavioral 3-month post-treatment results of a randomized controlled trial comparing glycemic excursion minimization (GEM) versus conventional weight loss (WL) therapy in the management of type 2 diabetes (T2D). GEM is a paradigm shift in the lifestyle management of T2D that focuses on reducing postnutrient glucose excursions, rather than reducing weight. We now present the 13-month follow-up results.

RESEARCH DESIGN AND METHODS: The initial study sample of 172 were 30-80 years old, had T2D for ≤10 years, an HbA1c ≥6.8% (51 mmol/mol), and were not using insulin. Participants were randomized to 6 hours of group treatment, either to WL or one of three versions of GEM. GEM groups differed in degree of blood glucose (BG) feedback provided during treatment: no recommended feedback, systematic capillary BG feedback before and after nutrient intake and physical activity, or continuous glucose monitoring. Since these GEM groups did not differ in pre-post improvement they were combined for initial and current analyses. Of those who completed the 3-month postassessment, 100% and 96% of the WL and GEM participants completed the 13-month follow-up assessment.

RESULTS: Pre to follow-up within-group comparisons indicated WL participants sustained improvement in body mass index (BMI) (-0.9±1.4, p=0.001). GEM participants continued to benefit in their HbA1c (-0.5±1.4, p<0.001), BMI (-1±1, p<0.001), high-density lipoprotein (p<0.001), reduction of carbohydrate ingestion (p<0.001), self-monitoring of blood glucose satisfaction (p<0.001) and frequency (p<0.001), diabetes knowledge (p<0.001), diabetes empowerment (p<0.001), and both diabetes distress emotional (p=0.009) and regimen (p=0.001) subscales. Forty-two percent and 52% of WL and GEM participants, respectively, were classified as responders (individuals whose A1c dropped by at least -0.5%), with a mean HbA1c reduction of -1.2% and -1.5%. Neither WL nor GEM responders differed from non-responders in baseline demographics, psychological or disease severity variables. While WL responders could not be predicted, 73% of GEM responders were predicted by post minus pretreatment reductions of HbA1c, diabetes medication and BMI.

CONCLUSIONS: While WL sustained improvement in BMI, GEM sustained benefits across a broad range of physical, behavioral and psychological parameters, beneficial for clinicians and adults with T2D. This may be especially relevant for primary care physicians who manage about 90% of patients with T2D.

TRIAL REGISTRATION NUMBER: NCT03196895.

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Keywords: diabetes mellitus; glycated hemoglobin A; hyperglycemia; life style; type 2

Conflict of interest statement

Competing interests: None declared.

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