title: 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.
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 events. The results from the HypoDE study shall help determine the advantage of using CGM in subjects with type 1 diabetes with an increased risk of low glucose events treated with MDI.
authors.affiliation: Science & Co, Düsseldorf, Germany L.Heinemann@science-co.com.
authors.forename: Lutz
authors.initials: L
authors.lastname: Heinemann
authors.affiliation: Endokrinologikum, Berlin, Germany.
authors.forename: Dorothee
authors.initials: D
authors.lastname: Deiss
authors.affiliation: Forschungsinstitut Diabetes Akademie Bad Mergentheim (FIDAM), Bad Mergentheim, Germany.
authors.forename: Norbert
authors.initials: N
authors.lastname: Hermanns
authors.affiliation: Dexcom, San Diego, CA, USA.
authors.forename: Claudia
authors.initials: C
authors.lastname: Graham
authors.affiliation: Leverkusen, Germany.
authors.forename: Matthias
authors.initials: M
authors.lastname: Kaltheuner
authors.affiliation: m&i-Fachklinik, Bad Heilbrunn, Germany.
authors.forename: Andreas
authors.initials: A
authors.lastname: Liebl
authors.affiliation: Forschungsinstitut Diabetes Akademie Bad Mergentheim (FIDAM), Bad Mergentheim, Germany.
authors.forename: David
authors.initials: D
authors.lastname: Price
mesh_terms: D000328:Adult; D001786:Blood Glucose / Q000032:analysis; D015190:Blood Glucose Self-Monitoring / Q000379:methods*; D003922:Diabetes Mellitus, Type 1 / Q000097:blood* / Q000175:diagnosis / Q000188:drug therapy*; D023381:Endpoint Determination; D005260:Female; D006801:Humans; D007003:Hypoglycemia / Q000188:drug therapy*; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000627:therapeutic use; D007328:Insulin / Q000008:administration & dosage / Q000627:therapeutic use; D007332:Insulin Infusion Systems; D008297:Male; D008875:Middle Aged; D016032:Randomized Controlled Trials as Topic; D012107:Research Design; D018570:Risk Assessment
chemical_list: D001786:Blood Glucose; D007004:Hypoglycemic Agents; D007328:Insulin
keywords: continuous glucose monitoring; hypoglycemic events; insulin pumps; multiple daily injections