A single-site feasibility randomised controlled trial comparing ‘my hypo compass’ short pyscho-educational intervention with standard care alone in individuals with type 1 diabetes and impaired awareness of hypoglycaemia

IF 3.2 3区医学 Q2 ENDOCRINOLOGY & METABOLISM

Diabetic Medicine Pub Date : 2024-06-26 DOI:10.1111/dme.15389

Ayat Bashir, Anneliese J. Flatt, Gez Richell, James A. M. Shaw

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Abstract

Aims

The HypoCOMPaSS multi-centre trial achieved improvement in hypoglycaemia awareness and 20-fold reduction in severe hypoglycaemia (SH) in a cohort with long-standing type 1 diabetes (T1D). All participants received ‘my hypo compass’ (MHC) brief structured psycho-educational intervention in addition to optimisation of insulin delivery/glucose monitoring. In this 24-week, prospective, single-centre feasibility RCT, we piloted MHC as a sole intervention in comparison to standard clinical care alone (CON).

Methods

Participants with T1D and impaired hypoglycaemia awareness (IAH) (Clarke score ≥4) were recruited. MHC comprised a group/individual 1–2 h face-to-face session followed by a telephone call and second face-to-face session at 4 weeks. Outcome measures at 24 weeks were compared with baseline.

Results

Fifty-two individuals provided consent for screening with 39 fulfilling eligibility criteria. Fifteen withdrew before any study intervention. Twenty-four adults with (mean ± SD) T1D duration 41.0 ± 15.1 years commenced/completed the study (100% visit attendance); 12 randomised to MHC and 12 to CON. All had IAH at baseline and at 24 weeks. Annualised SH rate following MHC was 3.8 ± 19.0 (24 weeks) versus 12.6 ± 3.5 (Baseline) and in CON group 2.0 ± 19.0 (24 weeks) versus 4.6 ± 11.5 (Baseline). ‘Immediate Action’ for and ‘Worry’ about hyperglycaemia measured by the Hyperglycaemia Avoidance Scale appeared lower following MHC. Participants attended all study visits and reflected positively on the MHC intervention.

Conclusions

Feasibility of MHC implementation without additional intervention has been demonstrated. MHC education was associated with positive changes in attitudes and behaviours with the potential to reduce SH risk. MHC provides a validated, simple, well-received programme to fulfil the educational component within RCTs targeting problematic hypoglycaemia and as part of holistic clinical care.

Abstract Image

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一项单点可行性随机对照试验，比较了 "我的低血糖指南针 "短期心理教育干预和单独的标准护理对低血糖意识受损的 1 型糖尿病患者的效果。

目的：HypoCOMPaSS 多中心试验提高了长期罹患 1 型糖尿病（T1D）的人群对低血糖的认识，并将严重低血糖（SH）的发生率降低了 20 倍。所有参与者都接受了 "我的低血糖指南针"（MHC）简短的结构化心理教育干预，同时还优化了胰岛素给药/血糖监测。在这项为期 24 周的前瞻性单中心可行性 RCT 试验中，我们将 MHC 作为一项单独的干预措施与单独的标准临床护理（CON）进行了比较：方法：招募患有 T1D 和低血糖意识受损（IAH）（克拉克评分≥4）的参与者。MHC包括1-2小时的小组/个人面对面治疗，然后是电话治疗和4周后的第二次面对面治疗。24周时的结果测量与基线进行比较：52人同意接受筛查，其中39人符合资格标准。15人在任何研究干预之前退出。24名T1D病程为（平均值±标度）41.0±15.1年的成人开始/完成了研究（100%就诊率）；12人随机接受MHC治疗，12人接受CON治疗。所有患者在基线和 24 周时均有 IAH。MHC组的年化SH率为3.8 ± 19.0（24周）对12.6 ± 3.5（基线），CON组的年化SH率为2.0 ± 19.0（24周）对4.6 ± 11.5（基线）。通过高血糖避免量表测量的对高血糖的 "立即行动 "和 "担忧 "在 MHC 后似乎有所降低。参与者参加了所有研究访问，并对 MHC 干预给予了积极评价：结论：无需额外干预即可实施 MHC 的可行性已得到证实。MHC教育与态度和行为的积极改变有关，有可能降低 SH 风险。MHC提供了一个经过验证、简单、广受欢迎的方案，可在针对问题性低血糖的RCT中实现教育部分，也可作为整体临床护理的一部分。

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来源期刊

Diabetic Medicine 医学-内分泌学与代谢

CiteScore

7.20

自引率

5.70%

发文量

229

审稿时长

3-6 weeks

期刊介绍： Diabetic Medicine, the official journal of Diabetes UK, is published monthly simultaneously, in print and online editions. The journal publishes a range of key information on all clinical aspects of diabetes mellitus, ranging from human genetic studies through clinical physiology and trials to diabetes epidemiology. We do not publish original animal or cell culture studies unless they are part of a study of clinical diabetes involving humans. Categories of publication include research articles, reviews, editorials, commentaries, and correspondence. All material is peer-reviewed. We aim to disseminate knowledge about diabetes research with the goal of improving the management of people with diabetes. The journal therefore seeks to provide a forum for the exchange of ideas between clinicians and researchers worldwide. Topics covered are of importance to all healthcare professionals working with people with diabetes, whether in primary care or specialist services. Surplus generated from the sale of Diabetic Medicine is used by Diabetes UK to know diabetes better and fight diabetes more effectively on behalf of all people affected by and at risk of diabetes as well as their families and carers.”