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)

March 9, 2018 updated by: Science Consulting in Diabetes
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

141

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Aschaffenburg, Germany
        • Gemeinschaftspraxis Dres. Klausmann
      • Bad Heilbrunn, Germany
        • m&i-Fachklinik Bad Heilbrunn
      • Bad Mergentheim, Germany
        • Forschungsinstitut Diabetes-Akademie Bad Mergentheim (FIDAM)
      • Bergheim, Germany
        • Diabetologische Schwerpunktpraxis
      • Berlin, Germany
        • Medicover Berlin-Mitte
      • Duisburg, Germany
        • Diabetologikum Duisburg
      • Essen, Germany
        • Diabetes Praxis Essen
      • Essen, Germany
        • Diabetologische Schwerpunktpraxis mit Fußambulanz
      • Hamburg, Germany
        • Zentrum für Diabetologie Bergedorf
      • Leverkusen, Germany
        • Gemeinschaftspraxis Dres. Kaltheuner
      • Marktredwitz, Germany, 95615
        • Diabetes Schwerpunkt Praxis Zentrum für Hormone und Stoffwechsel
      • Münster, Germany, 48153
        • Schwerpunktpraxis für Diabetes und Ernährungsmedizin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Experimental: CGM group
Device: Continuous Glucose Monitoring System
Other Names:
  • Dexcom G5 Mobile, Dexcom G4

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
For each subject, the experimental phase has an expected duration of up to 7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Science Consulting in Diabetes

Collaborators

DexCom, Inc. a Delaware corporation, USA
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Germany

Investigators

  • Principal Investigator: Norbert Hermanns, Prof., Forschungsinstitut Diabetes-Akademie Bad Mergentheim (FIDAM)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Actual)

July 14, 2017

Study Completion (Actual)

October 24, 2017

Study Registration Dates

First Submitted

January 25, 2016

First Submitted That Met QC Criteria

February 1, 2016

First Posted (Estimate)

February 2, 2016

Study Record Updates

Last Update Posted (Actual)

March 12, 2018

Last Update Submitted That Met QC Criteria

March 9, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IDT-1510-SI / HypoDE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes

Clinical Trials on Continuous Glucose Monitoring System

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Canada

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe