Scholarlink

Background <p>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).</p> Objective and Design <p>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 <i>my hypo compass for adults with T2D</i>, a psychoeducational intervention (PC+). </p> Participants <p>Adults with T2D on insulin or sulfonylurea and with a severe event in the prior 12&#xa0;months or impaired awareness of hypoglycemia.</p> Main Measures <p>Primary outcome was self-reported severe hypoglycemia over 12&#xa0;months, assessed at 14&#xa0;months.</p> Key Results <p>Ninety-two percent (<i>n</i> = 230) of 259 participants (67.2 ± 10.6&#xa0;years; 61% women) completed the trial. The proportion reporting ≥ 1 severe hypoglycemia event in the 12&#xa0;months before baseline was 34.1% in the PC arm and 24.8% in the PC + arm. At 14&#xa0;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 &lt; 54&#xa0;mg/dL for ≥ 15&#xa0;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.</p> Conclusions <p>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.</p> Trial Registration <p>ClinicalTrials.gov Identifier: NCT04863872</p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

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

  • 期刊论文

  • 发表日期：

    2026年5月12日

查看全文
  • James D. Ralston,
  • Melissa L. Anderson,
  • Janet Ng,
  • Ayat Bashir,
  • Kelly Ehrlich,
  • Dena Burns-Hunt,
  • Meredith Cotton,
  • Laurel Hansell,
  • Clarissa Hsu,
  • Helen Hunt,
  • Andrew J. Karter,
  • Shaula M. Levy,
  • Evette Ludman,
  • Lawrence Madziwa,
  • Emily M. Omura,
  • Kristine Rogers,
  • Brandie Sevey,
  • James A. M. Shaw,
  • Susan M. Shortreed,
  • Jane Speight,
  • Amber Sweeny,
  • Katherine Tschernisch,
  • Sergei Tschernisch,
  • Laura Yarborough

摘要

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