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)
1 other identifier
interventional
141
1 country
12
Brief Summary
Demonstrate that usage of RT-CGM (Real time continuous glucose monitoring) reduces the frequency of low CGM-recorded glucose events in patients using MDI (Multiple daily injections) that are at risk for hypoglycemic events.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable diabetes
Started Feb 2016
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 25, 2016
CompletedStudy Start
First participant enrolled
February 1, 2016
CompletedFirst Posted
Study publicly available on registry
February 2, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 14, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 24, 2017
CompletedMarch 12, 2018
March 1, 2018
1.4 years
January 25, 2016
March 9, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in the total number of low glucose events (<55 mg/dl), between baseline and outcome phase (week 22-26) in CGM group and control group (change = subtracting number of follow up events from number of baseline events
For each subject, the experimental phase has an expected duration of up to 7 months
Study Arms (2)
CGM group
EXPERIMENTALControl group
NO INTERVENTIONInterventions
Eligibility Criteria
You may qualify if:
- Patients with type 1 diabetes for at least 12 months on multiple daily injections (MDI). MDI is defined as prandial insulin injections at each major meal (excludes pre-mixed insulin) with doses determined by SMBG and carbohydrate counting, and basal insulin injection(s)
- 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
You may not qualify if:
- Use of personal real-time-CGM 3 months prior to study entry and during the study (except study devices)
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
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, 95615, Germany
Schwerpunktpraxis für Diabetes und Ernährungsmedizin
Münster, 48153, Germany
Related Publications (4)
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.
PMID: 40348338DERIVEDHermanns 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.
PMID: 35604794DERIVEDWaldenmaier 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.
PMID: 33863716DERIVEDHeinemann 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.
PMID: 29459019DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Norbert Hermanns, Prof.
Forschungsinstitut Diabetes-Akademie Bad Mergentheim (FIDAM)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 25, 2016
First Posted
February 2, 2016
Study Start
February 1, 2016
Primary Completion
July 14, 2017
Study Completion
October 24, 2017
Last Updated
March 12, 2018
Record last verified: 2018-03