- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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)
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
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Aschaffenburg, Tyskland
- Gemeinschaftspraxis Dres. Klausmann
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Bad Heilbrunn, Tyskland
- m&i-Fachklinik Bad Heilbrunn
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Bad Mergentheim, Tyskland
- Forschungsinstitut Diabetes-Akademie Bad Mergentheim (FIDAM)
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Bergheim, Tyskland
- Diabetologische Schwerpunktpraxis
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Berlin, Tyskland
- Medicover Berlin-Mitte
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Duisburg, Tyskland
- Diabetologikum Duisburg
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Essen, Tyskland
- Diabetes Praxis Essen
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Essen, Tyskland
- Diabetologische Schwerpunktpraxis mit Fußambulanz
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Hamburg, Tyskland
- Zentrum für Diabetologie Bergedorf
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Leverkusen, Tyskland
- Gemeinschaftspraxis Dres. Kaltheuner
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Marktredwitz, Tyskland, 95615
- Diabetes Schwerpunkt Praxis Zentrum für Hormone und Stoffwechsel
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Münster, Tyskland, 48153
- Schwerpunktpraxis für Diabetes und Ernährungsmedizin
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Inget ingripande: Kontrollgrupp
|
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Experimentell: CGM group
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Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
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
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Norbert Hermanns, Prof., Forschungsinstitut Diabetes-Akademie Bad Mergentheim (FIDAM)
Publikationer och användbara länkar
Allmänna publikationer
- 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.
- 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.
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- IDT-1510-SI / HypoDE
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