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Preventing Severe Hypoglycemia in Type 2 Diabetes: Randomized Controlled Trial of Proactive Care With Versus Without Psychoeducation

Lookup NU author(s): Dr Ayat Bashir, Professor James ShawORCiD

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Abstract

© The Author(s), under exclusive licence to Society of General Internal Medicine 2026. Background: Severe hypoglycemia is a feared complication of diabetes treatment. While psychoeducational programs reduce severe hypoglycemia in type 1 diabetes, their effectiveness is unclear in type 2 diabetes (T2D). Objective and Design: The Preventing Severe Hypoglycemia in Adults with Type 2 Diabetes (PHT2) randomized trial compared (a) proactive nurse care management (PC) and (b) PC augmented with my hypo compass for adults with T2D, a psychoeducational intervention (PC+). Participants: Adults with T2D on insulin or sulfonylurea and with a severe event in the prior 12 months or impaired awareness of hypoglycemia. Main Measures: Primary outcome was self-reported severe hypoglycemia over 12 months, assessed at 14 months. Key Results: Ninety-two percent (n = 230) of 259 participants (67.2 ± 10.6 years; 61% women) completed the trial. The proportion reporting ≥ 1 severe hypoglycemia event in the 12 months before baseline was 34.1% in the PC arm and 24.8% in the PC + arm. At 14 months, severe hypoglycemia did not differ significantly between arms (16.1% PC vs 11.6% PC + ; adjusted relative risk [aRR] 0.72 [95% confidence interval, 0.39 to 1.30]; adjusted absolute risk difference [aARD] −4.6 [95% confidence interval, −13.0 to 3.7]). Level 2 hypoglycemic events (glucose < 54 mg/dL for ≥ 15 min) were less frequent in the PC+ arm on the absolute risk scale but not on the relative risk scale (aRR 0.46 [95% confidence interval, 0.20 to 1.03]; aARD, −11.3% [95% confidence interval, −21.7 to −0.8]). No other secondary measures differed significantly between arms. Conclusions: Adding psychoeducational training to proactive care did not significantly reduce self-reported severe hypoglycemia compared to proactive care alone, with both groups experiencing a 50% reduction in severe hypoglycemia. Results should be interpreted with caution due to limited power. Trial Registration: ClinicalTrials.gov Identifier: NCT04863872


Publication metadata

Author(s): Ralston JD, Anderson ML, Ng J, Bashir A, Ehrlich K, Burns-Hunt D, Cotton M, Hansell L, Hsu C, Hunt H, Karter AJ, Levy SM, Ludman E, Madziwa L, Omura EM, Rogers K, Sevey B, Shaw JAM, Shortreed SM, Speight J, Sweeny A, Tschernisch K, Tschernisch S, Yarborough L

Publication type: Article

Publication status: Published

Journal: Journal of General Internal Medicine

Year: 2026

Pages: Epub ahead of print

Online publication date: 12/05/2026

Acceptance date: 24/04/2026

ISSN (print): 0884-8734

ISSN (electronic): 1525-1497

Publisher: Springer Nature

URL: https://doi.org/10.1007/s11606-026-10491-7

DOI: 10.1007/s11606-026-10491-7

PubMed id: 42118187


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