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临床试验/ACTRN12617000350325
ACTRN12617000350325已完成未知

Older People with Type 2 diabetes - Individualising Management wIth a SpecialisEd community team: Safety and feasibility study

Dr Rajna Ogrin0 个研究点目标入组 46 人开始时间: 2017年3月8日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
发起方
入组人数
46

研究概览

简要总结

The primary aim is to trial the safety and feasibility of a new model of diabetes care, aimed to optimise diabetes management and improve quality of life in the home using a specialised OPTIMISE: Older People with Type 2 diabetes Individualising Management wIth SpecialisEd community team. Results: 43 community-living adults were recruited between March 2017 and November 2018. Age range at enrolment was 65 to 92 years (mean 74 (SD 7) years). The mean (SD) duration of diabetes was 15 (9) years and the mean (SD) HbA1c at baseline was 7.4% (1.2%). More than half the participants had established macrovascular complications. Quality of life at baseline was low and diabetes negatively impacted on participants’ lives. There were no deaths nor serious adverse events causally related to the OPTIMISES program. None of the participants spent greater than 30% of time in severe hyperglycemic levels, however, 4 of 43 participants experienced significant hypoglycaemia. In total, 37 of 43 participants (86%) met all prespecified safety and feasibility criteria. Overall, the OPTIMISES program was considered both safe and feasible, and suitable for larger trials. The program was perceived positively by participants, outlined through five key themes: 1. Person Centred Attributes; 2. Interprofessional Team; 3. Organisational Supports; 4. The role of Technology; 5. Multi-faceted aspect of the program worked well.

研究设计

研究类型
Interventional
分配方式
Non-randomised trial
主要目的
Treatment
盲法
Open (masking not used)

入排标准

年龄范围
65 Years 至 o limit(—)
性别
All

入选标准

  • All newly registered clients to a community nursing organisation who:
  • * are 65 years or older
  • * have been diagnosed with type 2 diabetes
  • * have been referred to the community nursing organisation for diabetes management
  • * can speak and understand English

排除标准

  • * Are unable to consent, or don’t have a carer who is able to provide support for management of diabetes.
  • * Are under the care of an Endocrinologist, and who have been seen by the endocrinologist in the last six months.
  • * Do not currently have an acute infection, wound or recent change in condition that is affecting blood sugars
  • * Have been referred to the community nursing organisation for assistance commencing an injectable diabetes medication.
  • * Do not fit the inclusion criteria.

研究者

发起方
Dr Rajna Ogrin

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