Gestational diabetes mellitus: diagnosis and outcome.
Need for a revision of the Dutch perspective?
PhD ceremony: S.H. Koning, MSc
When: November 27, 2017
Promotors: prof. dr. B.H.R. (Bruce) Wolffenbuttel, P.P. van den Berg
Where: Academy building RUG, open to the public
Faculty: Medical Sciences / UMCG
Untreated gestational diabetes mellitus (GDM) is associated with an increased risk of complications for both mother and child. Many of these complications can be reduced by early diagnosis and treatment of GDM. However, worldwide there is a lack of agreement on the best way to diagnose and treat GDM.
In the Netherlands, the Dutch Society of Obstetrics and Gynaecology guideline “Diabetes and Pregnancy” for the screening and treatment of GDM was implemented in 2010. The diagnostic thresholds are based on the old WHO consensus originating from 1999 and have until now not been updated to the newest (more stringent) criteria, implemented in 2013. These new criteria have been adopted by many expert committees. However, evidence that applying the stricter criteria for GDM improves pregnancy outcomes is limited.
The research described in this thesis aimed to evaluate the current Dutch national guideline of GDM i.e. what is the outcome of GDM pregnancies using this guideline? And what are consequences when the current diagnostic criteria of GDM are to be revised?
In this thesis we have shown that the currently used national guideline for screening and treatment of GDM is successful in reducing the risk of short-term adverse outcomes, but not in reducing the likelihood of having a large-for-gestational-age neonate. We have also shown that the long-term care for GDM is far from optimal and requires further improvement. In order to further optimize GDM care and pregnancy outcomes we advise the use of more stringent blood glucose criteria for GDM diagnosis.
The cost-effectiveness of exenatide twice daily (BID) versus insulin lispro three times daily (TID) as add-on therapy to titrated insulin glargine in patients with type 2 diabetes
Authors: J. Gordon, P. McEwan, U. Sabale, B. Kartman & B.H.R Wolffenbuttel
Objective: To evaluate the cost-effectiveness of exenatide twice daily (BID) versus bolus insulin lispro three times daily (TID) as add-on therapy when glycemic control is suboptimal with titrated basal insulin glargine and metformin.
Methods: The analysis was based on the recent 4B Study, which compared exenatide BID and lispro TID as add-on therapies in subjects with type 2 diabetes insufficiently controlled despite titrated insulin glargine. The Cardiff Diabetes Model was used to simulate patient costs and health benefits beyond the 4B Study. The Swedish healthcare perspective was adopted for this analysis; costs are reported in €EUR to aid interpretation. The main outcome measure was the cost per quality-adjusted life-year (QALY) gained with exenatide BID compared to lispro TID.
Results: Exenatide BID was associated with an incremental cost of €1,270 and a QALY increase of +0.64 compared with lispro TID over 40 years. The cost per QALY gained with exenatide BID compared with lispro TID was €1,971, which is within conventional limits of cost-effectiveness. Cost-effectiveness results were generally robust to alternative assumptions and values for key model parameters.
Limitations: Extrapolation of trial data over the longer term can be influenced by modelling and parameter uncertainty. Cost-effectiveness results were generally insensitive to alternative values of key model input parameters and across scenarios.
Conclusions: The addition of exenatide BID rather than insulin lispro to basal insulin is associated with similar or better clinical outcomes. Illustrated from the Swedish healthcare perspective, analysis with the Cardiff Diabetes Model demonstrated that exenatide BID represents a cost-effective treatment alternative to lispro TID as add-on therapy in type 2 diabetes patients insufficiently controlled on basal insulin.