HypoDE: Research Design and Methods of a Randomized Controlled Study Evaluating the Impact of Real-Time CGM Usage on the Frequency of CGM Glucose Values <55 mg/dl in Patients With Type 1 Diabetes and Problematic Hypoglycemia Treated With Multiple Daily Injections

Journal of Diabetes Science and Technology
Lutz HeinemannDavid Price

Abstract

Systems for continuous glucose monitoring (CGM) have been available for a number of years, and numerous clinical studies have been performed with them. Interestingly, in many of these studies patients with an increased risk of hypoglycemic events were excluded. In addition, in most studies subjects were using a pump for insulin delivery. Therefore our knowledge about the benefit of CGM in patients employing multiple daily injections (MDI) of insulin is limited, especially when it comes to a reduction in the risk of low glucose events in high-risk individuals. We are planning to run a 26-week randomized controlled study in Germany (HypoDE, Hypoglycemia in Deutschland) that is focused on evaluating if such a reduction can be observed in patients on MDI with an increased risk of low glucose events. In all, 160 patients will participate in the study, randomized into the intervention group and control group. Ideally one would study if the frequency of severe hypoglycemic events is different between both groups. However, this would require such a large sample size and study duration, so for pragmatic reasons we will use low glucose levels <55 mg/dl (measured by CGM) for at least 20 minutes as a risk marker for severe hypoglycemic eve...Continue Reading

References

Aug 1, 1997·Diabetologia·S BottI Mühlhauser
Feb 10, 2000·The New England Journal of Medicine·UNKNOWN Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications Research GroupDavid M Nathan
Mar 1, 2005·Diabetes Care·William H PolonskyRichard A Jackson
Apr 28, 2005·Diabetes Care·UNKNOWN Workgroup on Hypoglycemia, American Diabetes Association
Jun 3, 2005·Diabetes Technology & Therapeutics·Bruce BuckinghamUNKNOWN Diabetes Research in Children Network
Jul 27, 2005·Diabetes Care·UNKNOWN Diabetes Research in Children Network (DirecNet) Study Group
Apr 5, 2008·Diabetic Medicine : a Journal of the British Diabetic Association·J GeddesB M Frier
Aug 22, 2008·Diabetes Technology & Therapeutics·Irl B HirschBruce A Buckingham
Nov 11, 2008·Endocrine Practice : Official Journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists·Philip E Cryer
May 12, 2009·Diabetes Care·UNKNOWN Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study GroupDongyuan Xing
Aug 14, 2009·Diabetes Care·UNKNOWN Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study GroupWilliam V Tamborlane
Jul 1, 2010·The New England Journal of Medicine·Richard M BergenstalUNKNOWN STAR 3 Study Group
Feb 8, 2011·Diabetic Medicine : a Journal of the British Diabetic Association·J HermanidesJ H DeVries
Feb 22, 2011·Diabetes Care·Tadej BattelinoJan Bolinder
Feb 25, 2011·Diabetes Care·Linda A Gonder-FrederickDaniel J Cox
Sep 2, 2011·Journal of Diabetes Science and Technology·Roy W BeckH Peter Chase
Sep 15, 2012·Diabetes, Obesity & Metabolism·E ZijlstraS Heckermann
Sep 26, 2012·Journal of Managed Care Pharmacy : JMCP·Sherita Hill Golden, Tamar Sapir
Oct 16, 2012·Journal of Diabetes Science and Technology·Baraka FloydGuillermo E Umpierrez
Nov 23, 2012·Diabetes Care·Andrea FacchinettiUNKNOWN AP@home Consortium
Jan 4, 2013·Diabetes Care·UNKNOWN American Diabetes Association
Mar 1, 2013·The New England Journal of Medicine·Moshe PhillipThomas Danne
May 2, 2013·Diabetes Technology & Therapeutics·Jesus Moreno-FernandezInes Rosa Gomez
Jun 14, 2013·The Journal of Clinical Endocrinology and Metabolism·Ruth S WeinstockUNKNOWN T1D Exchange Clinic Network
Jun 25, 2013·The New England Journal of Medicine·Richard M BergenstalUNKNOWN ASPIRE In-Home Study Group
Jul 26, 2013·The New England Journal of Medicine·Philip E Cryer
Oct 15, 2013·Diabetic Medicine : a Journal of the British Diabetic Association·H D WhiteP J Weston
Oct 25, 2013·Diabetic Medicine : a Journal of the British Diabetic Association·L Heinemann, J H DeVries

❮ Previous
Next ❯

Citations

Mar 8, 2019·Journal of Diabetes Science and Technology·Norbert HermannsDominic Ehrmann
May 28, 2019·Diabetic Medicine : a Journal of the British Diabetic Association·P ChoudharyF M Campbell
Feb 18, 2020·Journal of Diabetes Science and Technology·Ralph ZieglerBernd Kulzer
Dec 1, 2020·Diabetes Technology & Therapeutics·Jordan E PerlmanIrl B Hirsch
Jan 7, 2021·Journal of Diabetes Science and Technology·Giada AcciaroliHalis Kaan Akturk

❮ Previous
Next ❯

Software Mentioned

SYSTAT
HypoDE
GlucoWatch

Related Concepts

Trending Feeds

COVID-19

Coronaviruses encompass a large family of viruses that cause the common cold as well as more serious diseases, such as the ongoing outbreak of coronavirus disease 2019 (COVID-19; formally known as 2019-nCoV). Coronaviruses can spread from animals to humans; symptoms include fever, cough, shortness of breath, and breathing difficulties; in more severe cases, infection can lead to death. This feed covers recent research on COVID-19.

Blastomycosis

Blastomycosis fungal infections spread through inhaling Blastomyces dermatitidis spores. Discover the latest research on blastomycosis fungal infections here.

Nuclear Pore Complex in ALS/FTD

Alterations in nucleocytoplasmic transport, controlled by the nuclear pore complex, may be involved in the pathomechanism underlying multiple neurodegenerative diseases including Amyotrophic Lateral Sclerosis and Frontotemporal Dementia. Here is the latest research on the nuclear pore complex in ALS and FTD.

Applications of Molecular Barcoding

The concept of molecular barcoding is that each original DNA or RNA molecule is attached to a unique sequence barcode. Sequence reads having different barcodes represent different original molecules, while sequence reads having the same barcode are results of PCR duplication from one original molecule. Discover the latest research on molecular barcoding here.

Chronic Fatigue Syndrome

Chronic fatigue syndrome is a disease characterized by unexplained disabling fatigue; the pathology of which is incompletely understood. Discover the latest research on chronic fatigue syndrome here.

Evolution of Pluripotency

Pluripotency refers to the ability of a cell to develop into three primary germ cell layers of the embryo. This feed focuses on the mechanisms that underlie the evolution of pluripotency. Here is the latest research.

Position Effect Variegation

Position Effect Variagation occurs when a gene is inactivated due to its positioning near heterochromatic regions within a chromosome. Discover the latest research on Position Effect Variagation here.

STING Receptor Agonists

Stimulator of IFN genes (STING) are a group of transmembrane proteins that are involved in the induction of type I interferon that is important in the innate immune response. The stimulation of STING has been an active area of research in the treatment of cancer and infectious diseases. Here is the latest research on STING receptor agonists.

Microbicide

Microbicides are products that can be applied to vaginal or rectal mucosal surfaces with the goal of preventing, or at least significantly reducing, the transmission of sexually transmitted infections. Here is the latest research on microbicides.