Clinical trial NCT02671968: 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: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Keywords: CGM
hypoglycemic events
Lead sponsor: Science Consulting in Diabetes
Sponsor class: INDUSTRY
Collaborators: name: DexCom, Inc. a Delaware corporation, USA
name: Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Germany
First posted: 2016-02-02
Enrollment: 141
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

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.

Primary outcomes:
measure: 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
timeFrame: For each subject, the experimental phase has an expected duration of up to 7 months
Secondary outcomes:
Other outcomes:
Locations:
city: Aschaffenburg
country: Germany
facility: Gemeinschaftspraxis Dres. Klausmann
city: Bad Heilbrunn
country: Germany
facility: m&i-Fachklinik Bad Heilbrunn
city: Bad Mergentheim
country: Germany
facility: Forschungsinstitut Diabetes-Akademie Bad Mergentheim (FIDAM)
city: Bergheim
country: Germany
facility: Diabetologische Schwerpunktpraxis
city: Berlin
country: Germany
facility: Medicover Berlin-Mitte
city: Duisburg
country: Germany
facility: Diabetologikum Duisburg
city: Essen
country: Germany
facility: Diabetes Praxis Essen
city: Essen
country: Germany
facility: Diabetologische Schwerpunktpraxis mit Fußambulanz
city: Hamburg
country: Germany
facility: Zentrum für Diabetologie Bergedorf
city: Leverkusen
country: Germany
facility: Gemeinschaftspraxis Dres. Kaltheuner
city: Marktredwitz
country: Germany
facility: Diabetes Schwerpunkt Praxis Zentrum für Hormone und Stoffwechsel
city: Münster
country: Germany
facility: Schwerpunktpraxis für Diabetes und Ernährungsmedizin
Study officials:
affiliation: Forschungsinstitut Diabetes-Akademie Bad Mergentheim (FIDAM)
name: Norbert Hermanns, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hermanns N, Ehrmann D, Heinemann L, Freckmann G, Waldenmaier D, Calhoun P. Real-Time Continuous Glucose Monitoring Can Predict Severe Hypoglycemia in People with Type 1 Diabetes: Combined Analysis of the HypoDE and DIAMOND Trials. Diabetes Technol Ther. 2022 Sep;24(9):603-610. doi: 10.1089/dia.2022.0130. Epub 2022 Jun 10.
citation: Waldenmaier D, Freckmann G, Pleus S, Hermanns N, Ehrmann D, Heinemann L, Haug C. Therapy adjustments in people with type 1 diabetes with impaired hypoglycemia awareness on multiple daily injections using real-time continuous glucose monitoring: a mechanistic analysis of the HypoDE study. BMJ Open Diabetes Res Care. 2021 Apr;9(1):e001848. doi: 10.1136/bmjdrc-2020-001848.
citation: Heinemann L, Freckmann G, Ehrmann D, Faber-Heinemann G, Guerra S, Waldenmaier D, Hermanns N. 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. Lancet. 2018 Apr 7;391(10128):1367-1377. doi: 10.1016/S0140-6736(18)30297-6. Epub 2018 Feb 16.