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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

Tracking Information
First Submitted Date  ICMJE January 25, 2016
First Posted Date  ICMJE February 2, 2016
Last Update Posted Date March 12, 2018
Study Start Date  ICMJE February 2016
Actual Primary Completion Date July 14, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 1, 2016)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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)
Official Title  ICMJE 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)
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Condition  ICMJE Diabetes
Intervention  ICMJE Device: Continuous Glucose Monitoring System
Other Name: Dexcom G5 Mobile, Dexcom G4
Study Arms  ICMJE
  • Experimental: CGM group
    Intervention: Device: Continuous Glucose Monitoring System
  • No Intervention: Control group
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 25, 2017)
141
Original Estimated Enrollment  ICMJE
 (submitted: February 1, 2016)
160
Actual Study Completion Date  ICMJE October 24, 2017
Actual Primary Completion Date July 14, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02671968
Other Study ID Numbers  ICMJE IDT-1510-SI / HypoDE
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Science Consulting in Diabetes
Study Sponsor  ICMJE Science Consulting in Diabetes
Collaborators  ICMJE
  • DexCom, Inc. a Delaware corporation, USA
  • Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Germany
Investigators  ICMJE
Principal Investigator: Norbert Hermanns, Prof. Forschungsinstitut Diabetes-Akademie Bad Mergentheim (FIDAM)
PRS Account Science Consulting in Diabetes
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP