DiabetesNCT02671968
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)
A study testing Continuous Glucose Monitoring System in people with Diabetes, run by Science Consulting in Diabetes at 12 sites in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes
- What is being tested?
- Continuous Glucose Monitoring System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 12 sitesGermany
- Study dates
- Feb 2016to 24 Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Germany12 sites
Gemeinschaftspraxis Dres. Klausmann
Aschaffenburg
m&i-Fachklinik Bad Heilbrunn
Bad Heilbrunn
Forschungsinstitut Diabetes-Akademie Bad Mergentheim (FIDAM)
Bad Mergentheim
Diabetologische Schwerpunktpraxis
Bergheim
Medicover Berlin-Mitte
Berlin
Diabetologikum Duisburg
Duisburg
Diabetes Praxis Essen
Essen
Diabetologische Schwerpunktpraxis mit Fußambulanz
Essen
Zentrum für Diabetologie Bergedorf
Hamburg
Gemeinschaftspraxis Dres. Kaltheuner
Leverkusen
Diabetes Schwerpunkt Praxis Zentrum für Hormone und Stoffwechsel
Marktredwitz, 95615
Schwerpunktpraxis für Diabetes und Ernährungsmedizin
Münster, 48153
About this study
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.
Read the 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.
- Conditions
- Diabetes
- Being tested
- Continuous Glucose Monitoring System
- Keywords
- CGM, hypoglycemic events
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Glucose Monitoring SystemDevice
Also called Dexcom G5 Mobile, Dexcom G4
| Study group | Role | What they receive |
|---|---|---|
| CGM group | Experimental | Not described Receives: Device: Continuous Glucose Monitoring System |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: For each subject, the experimental phase has an expected duration of up to 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completion14 Jul 2017
- Study completion24 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Science Consulting in Diabetes
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- DexCom, Inc. a Delaware corporation, USA, Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
- Responsible party
- Sponsor
- Investigators
- Norbert Hermanns, Prof., Principal investigator, Forschungsinstitut Diabetes-Akademie Bad Mergentheim (FIDAM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02671968
- Sponsor's protocol ID
- IDT-1510-SI / HypoDE
- Status last verified
- Mar 2018
- First submitted
- 25 Jan 2016
- Last updated
- 12 Mar 2018
- Results posted
- No
Publications
Hermanns N, Heinemann L, Kulzer B, Schafer A, Jacobsen M, Ehrmann D. Continuous glucose monitoring as equinox of nocturnal and daytime hypoglycaemia in type 1 diabetes: insights from the randomized controlled HypoDE trial. Diabetes Res Clin Pract. 2025 Jun;224:112228. doi: 10.1016/j.diabres.2025.112228. Epub 2025 May 8.
PubMed 40348338Hermanns 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.
PubMed 35604794Waldenmaier 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.
PubMed 33863716Heinemann 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.
PubMed 29459019
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02671968
- Acronym / sponsor ID
- IDT-1510-SI / HypoDE
- Conditions
- Diabetes
- Keywords
- CGM, hypoglycemic events
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Science Consulting in DiabetesIndustry (pharma, biotech, devices)
- Collaborators
- DexCom, Inc. a Delaware corporation, USA, Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
- Study start
- Feb 2016
- Primary completion
- 14 Jul 2017 (actual)
- Study completion
- 24 Oct 2017 (actual)
- First posted
- 2 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CGM group | Experimental | Device: Continuous Glucose Monitoring System |
| Control group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous Glucose Monitoring SystemAlso: Dexcom G5 Mobile, Dexcom G4 | Device | CGM group |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2018.
- Derived from this study: PubMed 40348338Hermanns N, Heinemann L, Kulzer B, Schafer A, Jacobsen M, Ehrmann D. Continuous glucose monitoring as equinox of nocturnal and daytime hypoglycaemia in type 1 diabetes: insights from the randomized controlled HypoDE trial. Diabetes Res Clin Pract. 2025 Jun;224:112228. doi: 10.1016/j.diabres.2025.112228. Epub 2025 May 8.
- Derived from this study: PubMed 35604794Hermanns 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.
- Derived from this study: PubMed 33863716Waldenmaier 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.
- Derived from this study: PubMed 29459019Heinemann 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.
- 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.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Norbert Hermanns, Prof. principal investigator
Forschungsinstitut Diabetes-Akademie Bad Mergentheim (FIDAM)
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Glucose Monitoring System in people with Diabetes, run by Science Consulting in Diabetes at 12 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: For each subject, the experimental phase has an expected duration of up to 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02671968, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2018.