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)

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)

Sponsors

Lead Sponsor: Science Consulting in Diabetes

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

Source 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.

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.

Overall Status Completed
Start Date February 2016
Completion Date October 24, 2017
Primary Completion Date July 14, 2017
Phase N/A
Study Type Interventional
Primary 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 For each subject, the experimental phase has an expected duration of up to 7 months
Enrollment 141
Condition
Intervention

Intervention Type: Device

Intervention Name: Continuous Glucose Monitoring System

Arm Group Label: CGM group

Other Name: Dexcom G5 Mobile, Dexcom G4

Eligibility

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Norbert Hermanns, Prof. Principal Investigator Forschungsinstitut Diabetes-Akademie Bad Mergentheim (FIDAM)
Location
Facility:
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
Location Countries

Germany

Verification Date

March 2018

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: CGM group

Type: Experimental

Label: Control group

Type: No Intervention

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Source: ClinicalTrials.gov