NCT02666521

Hypoglycaemia in People With Type 2 Diabetes in Primary Care

Study to Determine the Frequency and Associated Predictors of Hypoglycaemia in People With Type 2 Diabetes Mellitus Managed in Primary Care

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,327 (actual)
• Sponsor: University of Leicester · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Despite type 2 diabetes comprising the majority of cases of diabetes, the overall frequency of hypoglycaemia in this group has not been as carefully documented as in type 1 diabetes, particularly in relation to the clinical use of individual therapies in primary care. The aim of this study is to provide robust data on the frequency and severity of hypoglycaemia in people with type 2 diabetes managed in primary care, and assess and explore associated risk factors.

Detailed description

Background - previous studies have provided robust evidence on the link between intensive therapy and increased frequency of hypoglycaemia in people with type 1 diabetes. Despite type 2 diabetes comprising the majority of cases of diabetes, the overall frequency of hypoglycaemia in this group has not been as carefully documented as in type 1 diabetes, particularly in relation to the clinical use of individual therapies in primary care. Recent prospective studies suggest that hypoglycaemia occurs more frequently than was previously thought for people with type 2 diabetes, particularly those treated with insulin and sulphonylureas. An increasingly elderly population, and earlier initiation of insulin and other newer therapies and treatment combinations, may influence the risk and severity of hypoglycaemic episodes. The overall aim is to undertake research that provides robust data on the frequency and severity of hypoglycaemia in people with type 2 diabetes managed in primary care, and assess and explore associated risk factors. PROSPECTIVE STUDY Aims - to prospectively evaluate the self-reported frequency and severity of hypoglycaemia in people with type 2 diabetes managed in primary care (stratified by participant treatment regime); to investigate the associated clinical and demographic predictors of hypoglycaemia. Methods - we will undertake a prospective, observational cohort study. Firstly, general practices will be approached to participate in the study, with an aim of recruiting around 20 practices throughout the UK. All recruited sites will receive relevant study training for the purposes of recruiting participants and collecting/recording research data. Participating general practices will then identify potentially eligible individuals on their practice register; individuals will be invited via a study invitation pack sent in the post or given in person when they attend the practice. Individuals expressing an interest will be invited to attend an appointment at their general practice where informed consent will be obtained and baseline data collected (demographic, bio-medical and self-completion questionnaires). Participants will be provided with relevant study materials (glucose monitoring diaries, hypoglycaemia recording forms, and a blood glucose meter and strips) and asked to measure their blood glucose and record any episodes of hypoglycaemia, over a period of 12-months. Repeat biomedical and self-completion questionnaire data will be collected at 12-months follow-up. The overall sample size for the prospective study is 422, based on recruiting a quota of participants on the following treatment regimens: 1) metformin only (n=62); 2) sulphonylurea based (n=140); 3) insulin based (n=140); and 4) incretin based (Dipeptidyl peptidase-4 (DPP4) or Glucagon-like peptide-1 (GLP-1)), (n=80). Practices will be asked to continue recruitment until targets are met for each of the treatment groups. CROSS SECTIONAL STUDY Aim - to provide data on the prevalence of hypoglycaemia in people with type 2 diabetes who are managed in primary care and explore associated risk factors. Methods - approach for participation will be made when potential volunteers attend for a planned appointment for diabetes care (e.g. diabetes annual review, diabetic retinopathy screening), through poster advertisement at the site. Their healthcare professional will also explain that there is a researcher at the clinic who is recruiting individuals with type 2 diabetes to take part in a research study. The researcher will then approach potential volunteers to provide a brief verbal explanation of the study, followed by a written participant information sheet for them to read. Subsequently, for individuals who volunteer to participate, they will be asked to sign a consent form and then given a questionnaire to self-complete (at their appointment or take home and post back to the research team). In addition, a researcher will obtain biomedical data from participants' medical records; no data will be collected until at least 48 hours has passed from the time informed consent was obtained, to allow time for participants who may change their mind about taking part. The anticipated recruitment target for the cross-sectional study is to recruit up to 2000 participants.

Conditions

• Diabetes Mellitus, Type 2
• Hypoglycemia

Timeline

• Start date: 2012-07-20
• Primary completion: 2017-06-30
• Completion: 2017-06-30
• First posted: 2016-01-28
• Last updated: 2018-05-02

Locations

1 site across 1 country: United Kingdom