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)

Diabetes Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02671968
• Other study ID #: IDT-1510-SI / HypoDE
• Status: Completed
• Phase: N/A
• First received: January 25, 2016
• Last updated: March 9, 2018
• Start date: February 2016
• Est. completion date: October 24, 2017

Study information

• Verified date: March 2018
• Source: Science Consulting in Diabetes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 141
• Est. completion date: October 24, 2017
• Est. primary completion date: July 14, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Device:
• Continuous Glucose Monitoring System

Locations

Country	Name	City	State
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	Schwerpunktpraxis für Diabetes und Ernährungsmedizin	Münster

Sponsors (3)

Lead Sponsor	Collaborator
Science Consulting in Diabetes	DexCom, Inc. a Delaware corporation, USA, Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   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.