Type 1 Diabetes Clinical Trial
Official title:
Blutzucker-Nachtprofile Mit Wecker Und Selbstmessungen gegenüber Fremdmessungen Durch Spezialisiertes Pflegepersonal: Eine Analyse Mittels Kontinuierlichem Glukose-Monitoring (Glucoday®)
Study hypothesis: Waking up in response to an alarm clock may evoke a stress reaction that
leads to rising glucose concentrations.
The purpose of this study was to prove this hypothesis with continuous glucose monitoring
over three nights.
Night (a) with an alarm clock set at 2 h intervals for glucose self monitoring,
Night (b) with a nurse performing blood glucose determinations, and
Night (c) with the patients left undisturbed.
Status | Completed |
Enrollment | 32 |
Est. completion date | September 2008 |
Est. primary completion date | September 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Type 1 Diabetic patients (diagnosed longer than 2 years) - HBA1c 5,0 - 9,5 % - Age 18-75 years - Hospitalized patients - Male or female, if female exclusion of pregnancy or secure contraception - Body-Mass-Index 19-40 kg/m² - Patient is elucidated - Patients agreement Exclusion Criteria: - Type 2-Diabetic patients or other forms of diabetes beside type 1 diabetes, diagnosed after the guidelines of the Deutsche Diabetes Gesellschaft - HbA1c < 5,0 % or > 9,5 % - A severe hypoglycemia with unconsciousness within the last 2 month - Body-Mass-Index < 19 or > 40 kg/m² - No patient agreement - Pregnancy (positive pregnancy test) or unsecured contraception. - Agina pectoris or acute myocardial infarct, as continuous problem - Inadequate treated arterial hypertension > 160 mmHg systolic and/or < 95 mmHg diastolic - Active tumor disease - Anemia hemoglobin < 11,5 g/dl - Treatment with steroids, sedative or anesthetics - Infection/fewer > 37.5 °C - Renal- malfunction (serum- creatinine > 1.5 mg/dl) - Liver- malfunction (GPT and AP > double of upper- limit) - Alcohol or drug abuse - Sleep disorder - Participation in clinical studies within the last 3 month - Other significant health dysfunctions, which would affect the outcome of this study - Incapable to conform the requirements of the protocol |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
Germany | Diabeteszentrum Bad Lauterberg im Harz | Bad Lauterberg | Lower Saxony |
Lead Sponsor | Collaborator |
---|---|
Diabeteszentrum Bad Lauterberg im Harz | Berlin-Chemie Menarini |
Germany,
Berndt C, Köthe L, Nawrodt B, Mraz B, Patzelt-Bath A. Glycaemic rises after waking up in response to an alarm clock during the night in type 1 diabetic patients can be avoided by experienced nurses drawing blood in a hospital setting as shown by continuou
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Glucose (continuous glucose monitoring) | 10 pm, midnight, 2 am, 4 am and 6:45 am continous glucose monitoring during three nights | No | |
Secondary | Hormones (norepinephrine, cortisol, glucagon, growth hormone, prolactin), Pulse, Blood glucose | 22 pm, midnight, 2 am, 4 am, 6:45 am | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05653518 -
Artificial Pancreas Technology to Reduce Glycemic Variability and Improve Cardiovascular Health in Type 1 Diabetes
|
N/A | |
Enrolling by invitation |
NCT05515939 -
Evaluating the InPen in Pediatric Type 1 Diabetes
|
||
Completed |
NCT05109520 -
Evaluation of Glycemic Control and Quality of Life in Adults With Type 1 Diabetes During Continuous Glucose Monitoring When Switching to Insulin Glargine 300 U/mL
|
||
Recruiting |
NCT04016987 -
Automated Structured Education Based on an App and AI in Chinese Patients With Type 1 Diabetes
|
N/A | |
Active, not recruiting |
NCT04190368 -
Team Clinic: Virtual Expansion of an Innovative Multi-Disciplinary Care Model for Adolescents and Young Adults With Type 1 Diabetes
|
N/A | |
Recruiting |
NCT05413005 -
Efficacy of Extracorporeal Photopheresis (ECP) in the Treatment of Type 1 Diabetes Mellitus
|
Early Phase 1 | |
Active, not recruiting |
NCT04668612 -
Dual-wave Boluses in Children With Type 1 Diabetes Insulin Boluses in Children With Type 1 Diabetes
|
N/A | |
Completed |
NCT02837094 -
Enhanced Epidermal Antigen Specific Immunotherapy Trial -1
|
Phase 1 | |
Recruiting |
NCT05414409 -
The Gut Microbiome in Type 1 Diabetes and Mechanism of Metformin Action
|
Phase 2 | |
Recruiting |
NCT05670366 -
The Integration of Physical Activity Into the Clinical Decision Process of People With Type 1 Diabetes
|
N/A | |
Active, not recruiting |
NCT05418699 -
Real-life Data From Diabetic Patients on Closed-loop Pumps
|
||
Completed |
NCT04084171 -
Safety of Artificial Pancreas Therapy in Preschoolers, Age 2-6
|
N/A | |
Recruiting |
NCT06144554 -
Post Market Registry for the Omnipod 5 System in Children and Adults With Type 1 Diabetes
|
||
Recruiting |
NCT05153070 -
Ciclosporin Followed by Low-dose IL-2 in Patients With Recently Diagnosed Type 1 Diabetes
|
Phase 2 | |
Recruiting |
NCT05379686 -
Low-Dose Glucagon and Advanced Hybrid Closed-Loop System for Prevention of Exercise-Induced Hypoglycaemia in People With Type 1 Diabetes
|
N/A | |
Completed |
NCT05281614 -
Immune Effects of Vedolizumab With or Without Anti-TNF Pre-treatment in T1D
|
Early Phase 1 | |
Withdrawn |
NCT04259775 -
Guided User-initiated Insulin Dose Enhancements (GUIDE) to Improve Outcomes for Youth With Type 1 Diabetes
|
N/A | |
Active, not recruiting |
NCT01600924 -
Study on the Assessment of Determinants of Muscle and Bone Strength Abnormalities in Diabetes
|
||
Completed |
NCT02897557 -
Insulet Artificial Pancreas Early Feasibility Study
|
N/A | |
Completed |
NCT02914886 -
Beneficial Effect of Insulin Glulisine by Lipoatrophy and Type 1 Diabetes (LAS)
|
Phase 4 |