Approved data access requests

2018: Web Accessible Population Pharmacokinetics Service - Hemophilia (WAPPS-Hemo) Service

Proposal number:

2018.001

Requested Studies

NN7999-3747

NN7999-3639

Lay summary

Short lay summary of the proposed research
The service will be a centralized, dedicated, web-accessible, actively moderated tool that allows the input of anonymized and certified hemophilia patient PK data. The service will provide expert validation of the estimation of the PK disposition of factor VIII/IX and report the results to the inputting physician. The service will facilitate the progressive accumulation of PK patient data which will be continuously enhanced by the data inputted into the system; thereby, allowing for progressive refinement of the knowledge of factor VIII and IX pharmacokinetics. The service will lead to a reduction in the need for blood plasma samples in individual patients. This should result in better care, intended both as more effective prophylaxis and optimization of resource utilization.

2017: Evaluation of clinical outcome in spontaneous intracerebral hemorrhage across age groups.

Proposal number:

2017.004

Requested Studies

F7ICH-1602

 

F7ICH-1371

 

F7ICH-2073

 

F7ICH-1389

 

F7ICH-1641

 

Lay summary

Short lay summary of the proposed research 
We know very little about how intracerebral hemorrhage affects the elderly. While what improves outcomes for younger people has been well documented little information exists concerning the elderly. We will describe this population looking for novel markers of improved outcome in elderly population. We hope this will lead to both improved manage of these elderly patients and novel therapeutic drug targets in intracerebral hemorrhage.

2017: The psychosocial impact of diabetes and diabetes care provision for people with severe mental illness: a patient, carer and healthcare staff survey

Proposal number:

2017.005

Requested Studies

INS-3966 (DAWN2)

Lay summary

Short lay summary of the proposed research 
People with a severe mental illness (SMI), e.g. schizophrenia or bipolar disorder, are almost three times more likely to have diabetes, and experience poorer health and healthcare than the general population. Diabetes has a major psychosocial impact, causing distress, poor quality of life and reduced capacity for self-management. People with SMI have additional psychological and social difficulties that are likely to increase their risk of diabetes distress and poor quality of life. However, very little is known about the impact of diabetes in this population. 
This study will explore the psychological and social impact of having diabetes alongside SMI and experience of diabetes healthcare. The aim is to increase understanding of how to improve diabetes care, including diabetes self-management for this vulnerable population. We will survey people with SMI and diabetes, their carers and healthcare professionals to examine the psychosocial impact of diabetes in SMI including diabetes distress, quality of life, and factors affecting diabetes self-management. Participants will be recruited through general practices and mental health services. We will compare findings with data from DAWN2, a global study of diabetes in the general population (http://www.dawnstudy.com/dawn2/about-dawn2.html). We will also test whether questions to measure diabetes distress and psychosocial impact are appropriate for people with 
SMI. Multi-stakeholder workshops will be used to discuss findings and identify opportunities to increase support for diabetes management. 
This study will provide insights on how diabetes can be managed more effectively for people with SMI. Study findings will be disseminated through our established research, clinical and service user networks to increase knowledge among clinicians and service providers, who sometimes make assumptions about why people with SMI experience poor diabetes outcomes (e.g. attributing blame to lifestyle and life choices). People with SMI and diabetes should experience better care, and improved physical and mental health outcomes as a result. 

2017: Safety and effectiveness of long-acting versus intermediate-acting insulin for patients with type 1 diabetes: a systematic review and individual patient data network meta-analysis

Proposal number:

2017.001

Requested Studies

NN304-1335

NN304-1708

NN304-1595

NN304-1448

NN304-1205

NN304-1430

NN304-1687

NN304-1316

NN304-1372

NN304-1447

NN304-1181

NN304-1243

NN304-1375

Lay summary

Short lay summary of the proposed research

Type 1 Diabetes Mellitus (T1DM) is a basal-bolus insulin regimen, for which two choices exist for basal insulin: long- and intermediate-acting insulin. These choices may have different risks of adverse events and effectiveness. To help patients and clinicians optimally select a basal insulin, knowledge regarding how the effectiveness of these agents differs across patient characteristics (eg, lifestyle, age, general health) is required. We aim to investigate the association between the individualized treatments for T1DM patients and A1C or severe hypoglycaemia. The results will be of interest to stakeholders and will help in improving existing guideline recommendations.

2016: Dipeptidyl-peptidase (DPP)-4 inhibitors or glucagon-like peptide (GLP)-1 analogues for prevention or delay of type 2 diabetes mellitus and its associated complications in persons at increased risk for the development of type 2 diabetes mellitus

Proposal number:

2016.001

Requested Studies

NN8022-1807 NN8022-3970 NN8022-1923 NN8022-1839

Lay summary

Short lay summary of the proposed research The incidence of type 2 diabetes is increasing worldwide. It is currently unknown if dipeptidyl-peptidase (DPP)-4 inhibitors or glucagon-like peptide (GLP)-1 analogues could prevent or delay type 2 diabetes mellitus and its associated complications in persons at increased risk for the development of type 2 diabetes mellitus. We will identify all published and unpublished trials including participants with increased risk of type 2 diabetes comparing DDP-4 inhibitors or GLP-1 analogues with no intervention, placebo or other glucose-lowering drugs with a duration of 12 weeks or more. Data and bias assessment will be performed by two authors. Data will be combined through meta-analysis. The outcomes assessed will be all-cause mortality; incidence of type 2 diabetes; serious adverse events, cardiovascular mortality; non-fatal myocardial infarction; congestive heart failure; non-fatal stroke; amputation of lower extremity; blindness or severe vision loss; end-stage renal disease; non-serious adverse events; hypoglycaemia; health-related quality of life; time to progression to type 2 diabetes; measures of blood glucose control; socioeconomic effects.

2015: Individual patient data meta-analysis of randomised controlled trials comparing glycaemic control during continuous subcutaneous insulin infusion vs. multiple daily insulin injections in type 2 diabetes mellitus

Proposal number:

2015.001

Requested Studies

ANA-2023

Lay summary

Insulin pump therapy has proved to be useful in improving diabetes control in selected people with type 1 diabetes but there has been conflicting evidence to date for its effectiveness in type 2 diabetes. In order to identify if there are patient groups that benefit more than others from insulin pump treatment in type 2 diabetes, we now wish to combine the data from all published randomised controlled trials on changes in control during pump therapy compared to best injection therapy (a ‘meta-analysis’). Using advanced statistical techniques, we will analyse the effect of individual patient characteristics such as level of diabetes control at the start of the study (HbA1c), weight and insulin dosage on the effect of pump therapy on HbA1c, hypoglycaemia, insulin dose and weight change.

Publications

Diabetes Care. 2017 May;40(5):715-722. doi: 10.2337/dc16-2201. Glycemic Control During Continuous Subcutaneous Insulin Infusion Versus Multiple Daily Insulin Injections in Type 2 Diabetes: Individual Patient Data Meta-analysis and Meta-regression of Randomized Controlled Trials. Pickup JC, Reznik Y, Sutton AJ

2015: Web Accessible Population Pharmacokinetics Service – Hemophilia (WAPPS-Hemo) Service

Proposal number:

2015.002

Requested Studies

NN7008-3893 NN7008-3522

Lay summary

Short lay summary of the proposed research The service will be a centralized, dedicated, web-accessible, actively moderated tool that allows the input of anonymized and certified haemophilia PK data. The service will provide expert validation of the estimation of the PK disposition of factor VIII/IX and report the results to the inputting physician. The service will facilitate the progressive accumulation of PK patient data which will be continuously enhanced by the data inputted into the system; thereby, allowing for progressive refinement of the knowledge of factor VIII and IX pharmacokinetics. The service will lead to a reduction in the need for blood plasma samples in individual patients. This should result in better care, intended both as more effective prophylaxis and optimization of resource utilization.

2014: Determination of HbA1c variability of 2 insulins, degludec and glargine, in the BEGIN once long trial

Proposal number:

2014.001

Requested Studies

NN1250-3579

Lay summary

The HbA1c test is a measure of diabetes glucose control over a 2 month period and may vary month by month depending on overall glucose control. We have shown for patients with type 1 diabetes that over the months those patients whose HbA1c remains steady have fewer diabetes related problems than those whose HbA1c varies. By looking at the data from the BEGIN once long study over a 12 month period, we can see if the HbA1c variability for one type of insulin (degludec) is less than for another (glargine) in type 2 diabetes. This may provide information on which to base a long term study in the future.