CQR15003-Obs study to assess PaQ in patients with Type 2 Diabetes
Research type
Research Study
Full title
A multicenter, observational study to assess performance of PaQ in insulin-using patients with Type 2 diabetes.
IRAS ID
192226
Contact name
Stephen Bain
Contact email
Sponsor organisation
CeQur Corporation
Duration of Study in the UK
1 years, 3 months, 22 days
Research summary
Type 2 diabetes mellitus (T2DM) is a metabolic disorder that is characterised by high blood glucose in the context of insulin resistance and relative lack of insulin. The International Diabetes Federation (IDF) estimates that 382 million people around the world have diabetes; an estimated 175 million are undiagnosed. T2DM accounts for about approximately 85% to 95% of all diagnosed diabetes cases. It is not known what causes T2DM; however, a number of factors have been identified which put individuals at risk for the disease, such as family history, obesity, and sedentary lifestyle.
Recent diabetes treatment guidelines have highlighted the importance of insulin therapy earlier in the course of treatment. A basal-bolus routine involves taking a longer acting form of insulin to keep blood glucose levels stable through periods of fasting and separate injections of shorter acting insulin to prevent rises in blood glucose levels resulting from meals. Recent studies showed that when basal-bolus therapy was initiated in a group of study patients after 2 years, nearly half were able to reach a HbA1C of 48 mmol/mol and approximately 60% were able to reach a HbA1C of 53 mmol/mol.
PaQ is a simple insulin delivery device (pre-set daily basal rates, no programming), designed for insulin-using patients with diabetes mellitus.
This study is an 18 week open-label, uncontrolled, observational study to evaluate the performance of continuous subcutaneous insulin infusion (CSII) with PaQ, as measured by HbA1C, after 3 months of treatment in patients with type 2 diabetes. A total sample size of approximately 60 patients with diabetes not achieving glycemic targets will be involved in this study. During the study certain procedures will be carried out to see if the study device is working, they include completion of questionnaires, fasting blood glucose &blood analyses and review of patient diary.REC name
Wales REC 6
REC reference
16/WA/0155
Date of REC Opinion
23 May 2016
REC opinion
Favourable Opinion