Treating Early Type 2 Diabetes by Reducing Postprandial Glucose Excursions: a Paradigm Shift in Lifestyle Modification (GEM)

Keywords

Types of Research

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Clinical research

Summary

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Participants newly diagnosed with type 2 diabetes will be randomized 1:1 to Routine Care (RC) or Routine Care + Glycemic Excursion Minimization (RC+GEM). Participants will participate for up to 13.5 months and will be provided with a CGM and Fitbit. RC+GEM participants will complete a 6-week GEM intervention. Primary outcomes include A1c and current diabetes medications. We anticipate that RC+GEM will: 1) reduce hemoglobin A1c as much or more, 2) require less diabetes medication, 3) cost less, and 4) have more secondary benefits, (e.g. greater reduction in cardiovascular risk, weight, diabetes distress, depression symptoms), compared to RC alone. 

References

1. Oser TK, Varney C, McCall AL, Cox DJ. Current and new treatment options for adults recently diagnosed with type 2 diabetes. Family Medicine and Community Health. 2025 Feb 17;13(1):e003154.
2. Oser TK, Cucuzzella M, Stasinopoulos M, Moncrief M, McCall A, Cox DJ. An innovative, paradigm-shifting lifestyle intervention to reduce glucose excursions with the use of continuous glucose monitoring to educate, motivate, and activate adults with newly diagnosed type 2 diabetes: pilot feasibility study. JMIR diabetes. 2022 Feb 23;7(1):e34465.
3. 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 Research and Care. 2021 Nov 1;9(2):e002403.
4. Cox DJ, Banton T, Moncrief M, Conaway M, Diamond A, McCall AL. Minimizing glucose excursions (GEM) with continuous glucose monitoring in type 2 diabetes: a randomized clinical trial. Journal of the Endocrine Society. 2020 Nov;4(11):bvaa118.
5. Cox DJ, Banton T, Moncrief M, Conaway M, Diamond A, Holmes V, Pastors JG, Wolf A, Fang K, McCall A. Glycemic excursion minimization in the management of type 2 diabetes: a novel intervention tested in a randomized clinical trial. BMJ Open Diabetes Research & Care. 2020 Dec 16;8(2).
6. Cox DJ, Taylor AG, Singh H, Moncrief M, Diamond A, Yancy Jr WS, Hegde S, McCall AL. Glycemic load, exercise, and monitoring blood glucose (GEM): a paradigm shift in the treatment of type 2 diabetes mellitus. Diabetes Research and Clinical Practice. 2016 Jan 1;111:28-35.
   

Significance

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Up to 50% of adults with type 2 diabetes do not meet glycemic targets despite the continued development of new pharmacologic interventions. The addition of lifestyle and empowerment programs such as GEM have the potential to improve clinical and psychosocial outcomes while reducing healthcare costs.

Impact

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GEM reduces glucose elevations with lower carbohydrate intake, hastens blood glucose recovery by increased physical activity, and increases diabetes empowerment while reducing diabetes distress and depressive symptoms. This has contributed to relatively long-term (13 months) follow-up benefits with no booster intervention.  

Lessons Learned

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Coming soon.

Presentations

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• Westfeldt E, Prince B, Huss K, Moncrief M, Rynders C, McCall A, Parascando JA, Cox DJ, Fabris C, Oser TK. Treating Early “Type 2 Diabetes by Reducing Postprandial Glucose Excursions: A Paradigm Shift in Lifestyle Modification (poster).” Colorado Pragmatic Research in Health Conference (COPRH Con), Aurora, CO | 4-5 June 2025. 
• Kahraman A, Prince B, Westfeldt E, Huss K, Parascando J, Buss D, Sarwal A, Kumar S, Moncrief M, Rynders C, Varney C, McCall A, Cox DJ, Fabris C, Oser TK. Treating Early Type 2 Diabetes by Reducing Postprandial Glucose Excursions: A Paradigm Shift in Lifestyle Modification. Diabetes Day 2025, Amsterdam | 21 March 2025.
• Fabris C, Oser TK, Cox D. Glycemic Excursion Minimization (GEM): A Lifestyle Intervention for the Management of Type 2 Diabetes. 19th International Conference for Advanced Technologies & Treatments for Diabetes (ATTD), Aurora CO | 19-22 March 2025.
• Prince B, Westfeldt E, Huss K, Parascando J, Buss D, Sarwal A, Kumar S, Moncrief M, Rynders C, Varney C, McCall A, Cox DJ, Fabris C, Oser TK. Treating Early Type 2 Diabetes by Reducing Postprandial Glucose Excursions: A Paradigm Shift in Lifestyle Modification. 2024 North American Primary Care Research Group (NAPCRG) Annual Conference, Québec City, Québec, Canada | 20-24 November 2024.
• Westfeldt E, Prince B, Huss K, Oser SM, Oser TK. “Treating Early Type 2 Diabetes by Reducing Postprandial Glucose Excursions: A Paradigm Shift in Lifestyle Modification (poster).” 51st NAPCRG Annual Meeting, North American Primary Care Research Group, San Francisco, CA United States. | 30 October – 3 November 2023.