Introduction: Reducing carbohydrate intake improves glycemia in people with T2D. Data on nutrition interventions using CGM are sparse. IGNITE (Impact of Glucose moNitoring and nutrItion on Time in rangE) compared differences in change in CGM-derived TIR (% time with glucose 70‑180 mg/dL) from baseline (Base) to three months (M3) in people using CGM or BGM during a medically supervised ketogenic diet program (MSKDP) delivered via continuous remote care.
Methods: IGNITE (NCT05516797) randomized adults with T2D to CGM (N=81) or BGM (N=82). CGM and BGM data were used by participants and the care team to support dietary adherence and medication management decisions. Blinded CGM data at Base were compared to CGM data at M3 (blinded for BGM and cloud-based for CGM).
Results: At baseline, participants were (mean + SD) 53 + 10 years; 106 + 25 kg; 10 + 8 years with T2D; taking 2.2 + 1.0 diabetes medications, and HbA1c 8.1% + 1.2%, with no differences between arms. TIR improved (Base to M3) for both arms, 28% for CGM and 23% for BGM (p<0.001) with no difference in change between arms (p=0.4); the % time <70 mg/dL and <54 mg/dL was negligible. Reaching TIR >70% and % time <70 mg/dL (TBR) <4% favored CGM arm. Full outcomes in Table 1.
Conclusion: TIR improved significantly for both CGM and BGM arms at M3. However, CGM users were more likely to see improvement in the combined CGM metrics of TIR >70% and TBR <4%.
H.J. Willis: Research Support; Abbott. Other Relationship; Abbott. Research Support; Academy of Nutrition and Dietetics, Dexcom, Inc. S.E. Asche: Stock/Shareholder; Gilead Sciences, Inc., AbbVie Inc., GlaxoSmithKline plc. A.L. McKenzie: Employee; Virta Health Corp. Stock/Shareholder; Virta Health Corp. Employee; Abbott. R.N. Adams: Employee; Virta Health Corp. Stock/Shareholder; Virta Health Corp. S. Krizka: None. C.G.P. Roberts: Other Relationship; Virta Health Corp. B.M. Volk: Employee; Virta Health Corp. Stock/Shareholder; Virta Health Corp. S.J. Athinarayanan: Employee; Virta Health Corp. A.R. Zoller: Employee; Virta Health Corp. Stock/Shareholder; Virta Health Corp. R.M. Bergenstal: Other Relationship; Abbott. Research Support; Arkray Marketing. Consultant; Ascensia Diabetes Care, Bigfoot Biomedical, Inc., CeQur. Other Relationship; Dexcom, Inc., Eli Lilly and Company. Consultant; embecta, Hygieia. Research Support; Insulet Corporation. Consultant; MannKind Corporation. Other Relationship; Medtronic, Novo Nordisk. Consultant; Onduo LLC, Roche Diabetes Care. Other Relationship; Sanofi. Research Support; Tandem Diabetes Care, Inc. Other Relationship; UnitedHealth Group. Consultant; Vertex Pharmaceuticals Incorporated, Zealand Pharma A/S.
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