Real-Time Continuous Glucose Monitoring (RT-CGM) in Patients With Type 1 Diabetes at High Risk for Low Glucose Values Using Multiple Daily Injections (MDI) in Germany (HYPODE-STUDY)
NCT ID: NCT02671968
Last Updated: 2018-03-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
141 participants
INTERVENTIONAL
2016-02-29
2017-10-24
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effect of Continuous Glucose Monitoring on Course of Glucose in Type 1 Diabetes
NCT00467688
Randomized Study of Real-Time Continuous Glucose Monitors (RT-CGM) in the Management of Type 1 Diabetes
NCT00406133
The Effects of RT-CGM on Glycemia and QoL in Patients With T1DM and IHA
NCT01787903
RT-CGM in Young Adults at Risk of DKA
NCT04039763
Effect of CGM With Predictive Alarm on Hypoglycemia in Young Patients With T1D.
NCT05574023
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Secondary is tested if patients in the CGM group showed a significantly more favorable change in the below defined secondary endpoint than patients in the control group after 26 weeks follow up.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
CGM group
Continuous Glucose Monitoring System
Control group
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Continuous Glucose Monitoring System
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Age ≥ 18 years
* HbA1c ≤ 9.0 % performed within 4 months before begin of the study
* High risk for severe hypoglycemia (defined as a score of 4 or higher on the Hypoglycemia unawareness scale (HUS) or a history of at least one severe hypoglycemic event in the last 12 months (required third part assistance, not able to treat themselves))
* Willing to not use paracetamol or drugs containing it
* Signed and dated Informed Consent Form
Exclusion Criteria
* Use of a flash-glucose monitoring system 3 months prior to study and during the study
* Alcoholism or drug abuse
* Unable to comply with the protocol at the investigators discretion, such as known psychiatric diagnosis, cognitive / physical decline
* Pregnancy or lactation period
* Severe known allergies, e.g. against plaster
* Mental incapacity or language barriers precluding adequate compliance with the study procedures
* Limited or no legal capacity or legal guardianship
* Dependency from the sponsor or the clinical investigator (e.g. co-workers of the sponsor or the clinical research center or their families)
* Participation in another study at the same time with a non-approved drug or a non-CE-labelled medical device.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
DexCom, Inc. a Delaware corporation, USA
UNKNOWN
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Germany
UNKNOWN
Science Consulting in Diabetes
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Norbert Hermanns, Prof.
Role: PRINCIPAL_INVESTIGATOR
Forschungsinstitut Diabetes-Akademie Bad Mergentheim (FIDAM)
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Gemeinschaftspraxis Dres. Klausmann
Aschaffenburg, , Germany
m&i-Fachklinik Bad Heilbrunn
Bad Heilbrunn, , Germany
Forschungsinstitut Diabetes-Akademie Bad Mergentheim (FIDAM)
Bad Mergentheim, , Germany
Diabetologische Schwerpunktpraxis
Bergheim, , Germany
Medicover Berlin-Mitte
Berlin, , Germany
Diabetologikum Duisburg
Duisburg, , Germany
Diabetes Praxis Essen
Essen, , Germany
Diabetologische Schwerpunktpraxis mit Fußambulanz
Essen, , Germany
Zentrum für Diabetologie Bergedorf
Hamburg, , Germany
Gemeinschaftspraxis Dres. Kaltheuner
Leverkusen, , Germany
Diabetes Schwerpunkt Praxis Zentrum für Hormone und Stoffwechsel
Marktredwitz, , Germany
Schwerpunktpraxis für Diabetes und Ernährungsmedizin
Münster, , Germany
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Hermanns N, Heinemann L, Kulzer B, Schafer A, Jacobsen M, Ehrmann D. Continuous glucose monitoring as equinox of nocturnal and daytime hypoglycaemia in type 1 diabetes: insights from the randomized controlled HypoDE trial. Diabetes Res Clin Pract. 2025 Jun;224:112228. doi: 10.1016/j.diabres.2025.112228. Epub 2025 May 8.
Hermanns N, Ehrmann D, Heinemann L, Freckmann G, Waldenmaier D, Calhoun P. Real-Time Continuous Glucose Monitoring Can Predict Severe Hypoglycemia in People with Type 1 Diabetes: Combined Analysis of the HypoDE and DIAMOND Trials. Diabetes Technol Ther. 2022 Sep;24(9):603-610. doi: 10.1089/dia.2022.0130. Epub 2022 Jun 10.
Waldenmaier D, Freckmann G, Pleus S, Hermanns N, Ehrmann D, Heinemann L, Haug C. Therapy adjustments in people with type 1 diabetes with impaired hypoglycemia awareness on multiple daily injections using real-time continuous glucose monitoring: a mechanistic analysis of the HypoDE study. BMJ Open Diabetes Res Care. 2021 Apr;9(1):e001848. doi: 10.1136/bmjdrc-2020-001848.
Heinemann L, Freckmann G, Ehrmann D, Faber-Heinemann G, Guerra S, Waldenmaier D, Hermanns N. Real-time continuous glucose monitoring in adults with type 1 diabetes and impaired hypoglycaemia awareness or severe hypoglycaemia treated with multiple daily insulin injections (HypoDE): a multicentre, randomised controlled trial. Lancet. 2018 Apr 7;391(10128):1367-1377. doi: 10.1016/S0140-6736(18)30297-6. Epub 2018 Feb 16.
Related Links
Access external resources that provide additional context or updates about the study.
Real-time continuous glucose monitoring in adults with type 1 diabetes and impaired hypoglycaemia awareness or severe hypoglycaemia treated with multiple daily insulin injections (HypoDE): a multicentre, randomised controlled trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IDT-1510-SI / HypoDE
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.