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)

Conditions

Diabetes

Keywords

CGM, hypoglycemic events

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.

Norbert Hermanns, Lutz Heinemann, Bernhard Kulzer, Arne Schäfer, Malte Jacobsen et al. (6 authors)

Diabetes Research and Clinical Practice2025-05-08

10.1016/j.diabres.2025.112228

Real-Time Continuous Glucose Monitoring Can Predict Severe Hypoglycemia in People with Type 1 Diabetes: Combined Analysis of the HypoDE and DIAMOND Trials

Norbert Hermanns, Dominic Ehrmann, Lutz Heinemann, Guido Freckmann, Delia Waldenmaier et al. (6 authors)

Diabetes Technology & Therapeutics2022-05-2311 citations

10.1089/dia.2022.0130

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

Delia Waldenmaier, Guido Freckmann, Stefan Pleus, Norbert Hermanns, Dominic Ehrmann et al. (7 authors)

BMJ Open Diabetes Research & Care2021-04-019 citations

10.1136/bmjdrc-2020-001848

Mitigation of Rebound Hyperglycemia With Real-Time Continuous Glucose Monitoring Data and Predictive Alerts

Giada Acciaroli, John Welsh, Halis Kaan Aktürk

Journal of Diabetes Science and Technology2021-01-0525 citations

10.1177/1932296820982584

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.

Heinemann L, Freckmann G, Ehrmann D, Faber-Heinemann G, Guerra S, Waldenmaier D, Hermanns N.

2018-02-16373 citations

10.1016/s0140-6736(18)30297-6

Interventions

DEVICEContinuous Glucose Monitoring System

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

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.

Design outcomes

Primary

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

Countries

Germany

Outcome results

None listed