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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)

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ClinicalTrials.gov Identifier: NCT02671968
Recruitment Status : Completed
First Posted : February 2, 2016
Last Update Posted : March 12, 2018
Sponsor:
Collaborators:
DexCom, Inc. a Delaware corporation, USA
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Germany
Information provided by (Responsible Party):
Science Consulting in Diabetes

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.

Condition or disease Intervention/treatment Phase
Diabetes Device: Continuous Glucose Monitoring System Not Applicable

Detailed Description:

In a randomized controlled trial the primary hypothesis is tested if the usage of RT-CGM in the intervention group (CGM group) reduces the frequency of glucose values <55 mg/dl in patients with hypoglycemia problems (hypoglycemia unawareness or documented previous severe hypoglycemia) significantly more than in the control group receiving usual care (without CGM).

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 141 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Official Title: 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)
Study Start Date : February 2016
Actual Primary Completion Date : July 14, 2017
Actual Study Completion Date : October 24, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

Arm Intervention/treatment
Experimental: CGM group Device: Continuous Glucose Monitoring System
Other Name: Dexcom G5 Mobile, Dexcom G4

No Intervention: Control group



Primary Outcome Measures :
  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 [ Time Frame: For each subject, the experimental phase has an expected duration of up to 7 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02671968


Locations
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Germany
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, 95615
Schwerpunktpraxis für Diabetes und Ernährungsmedizin
Münster, Germany, 48153
Sponsors and Collaborators
Science Consulting in Diabetes
DexCom, Inc. a Delaware corporation, USA
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Germany
Investigators
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Principal Investigator: Norbert Hermanns, Prof. Forschungsinstitut Diabetes-Akademie Bad Mergentheim (FIDAM)
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Science Consulting in Diabetes
ClinicalTrials.gov Identifier: NCT02671968    
Other Study ID Numbers: IDT-1510-SI / HypoDE
First Posted: February 2, 2016    Key Record Dates
Last Update Posted: March 12, 2018
Last Verified: March 2018
Keywords provided by Science Consulting in Diabetes:
CGM
hypoglycemic events
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases