ArticleJournal of diabetes science and technology2015
HypoDE: Research Design and Methods of a Randomized Controlled Study Evaluating the Impact of Real-Time CGM Usage on the Frequency of CGM Glucose Values <55 mg/dl in Patients With Type 1 Diabetes and Problematic Hypoglycemia Treated With Multiple Daily Injections.
Article in Journal of diabetes science and technology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 10 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Supporting Primary Care Adoption, Resources, and Knowledge for Continuous Glucose Monitoring
Implementation of Networked Continuous Glucose Monitoring With Telemetry Within the Intensive Care Unit (ICU-TeleCGM)
Who cites it
10 citing papers in PubMed, 17 citations in OpenAlex.
- Mitigation of Rebound Hyperglycemia With Real-Time Continuous Glucose Monitoring Data and Predictive Alerts.Journal of diabetes science and technology · 2022Trial
- Primary Care-Initiated Continuous Glucose Monitoring in Adults With Insulin-Treated Diabetes.JAMA network open · 2026Article
- Intermittent Use of Continuous Glucose Monitoring: Expanding the Clinical Value of CGM.Journal of diabetes science and technology · 2021Article
- HbA1c and Glucose Management Indicator Discordance: A Real-World Analysis.Diabetes technology & therapeutics · 2021Article
- 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 research & care · 2021Article
- Article
- Rationale and protocol for the Assessment of Impact of Real-time Continuous Glucose Monitoring on people presenting with severe Hypoglycaemia (AIR-CGM) study.BMC endocrine disorders · 2019Article
- Impact of CGM on the Management of Hypoglycemia Problems: Overview and Secondary Analysis of the HypoDE Study.Journal of diabetes science and technology · 2019Review
- Healthcare Resource Waste Associated with Patient Nonadherence and Early Discontinuation of Traditional Continuous Glucose Monitoring in Real-World Settings: A Multicountry Analysis.Diabetes technology & therapeutics · 2018Article
- The Potential Cost Implications of Averting Severe Hypoglycemic Events Requiring Hospitalization in High-Risk Adults With Type 1 Diabetes Using Real-Time Continuous Glucose Monitoring.Journal of diabetes science and technology · 2016Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 4 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Systems for continuous glucose monitoring (CGM) have been available for a number of years, and numerous clinical studies have been performed with them. Interestingly, in many of these studies patients with an increased risk of hypoglycemic events were excluded. In addition, in most studies subjects were using a pump for insulin delivery. Therefore our knowledge about the benefit of CGM in patients employing multiple daily injections (MDI) of insulin is limited, especially when it comes to a reduction in the risk of low glucose events in high-risk individuals. We are planning to run a 26-week randomized controlled study in Germany (HypoDE, Hypoglycemia in Deutschland) that is focused on evaluating if such a reduction can be observed in patients on MDI with an increased risk of low glucose events. In all, 160 patients will participate in the study, randomized into the intervention group and control group. Ideally one would study if the frequency of severe hypoglycemic events is different between both groups. However, this would require such a large sample size and study duration, so for pragmatic reasons we will use low glucose levels <55 mg/dl (measured by CGM) for at least 20 minutes as a risk marker for severe hypoglycemic events. The results from the HypoDE study shall help determine the advantage of using CGM in subjects with type 1 diabetes with an increased risk of low glucose events treated with MDI.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.