multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII) E10
Conditions
Interventions
Group 1: Patients with type 1 diabetes on multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII) wear 2 Dexcom G5 Mobile-System sensors (continuous measurement of glucose)
Sponsors
Institut für Diabetes-Technologie, Foschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: - Patients with type 1 diabetes on multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII) according to ADA / WHO-definition - = 18 years of age - > 45 years of age: profound examination with cardiovascular risk assessment - Signed and dated Informed Consent Form Clinical chemical parameters (AST/GOT, ALT/GPT, GGT, Creatinine, Urea, Uric acid, Sodium, Potassium, Calcium), haematology parameters (Hematocrit, Hemoglobin, Erythrocytes, Leukocytes, Thrombocytes) and Coagulation parameters (INR, PTT) in the normal range or insignificantly altered with respect to the study purpose and procedures as well as the safety of the subjects as determined by the investigator
Exclusion criteria
Exclusion criteria: - > 65 years of age - Age > 45 years: Patients with more than three risk factors for cardiovascular diseases will not be included in the study. Risk factors for cardiovascular diseases: 1.) age > 45 years 2.) diabetes mellitus 3.) further risk factors, e.g. smoking, treated arterial hypertension or systolic blood pressure > 140 mm Hg or diastolic blood pressure > 90 mm Hg), Hyperlipidaemia (elevated total cholesterol, elevated LDL cholesterol), HbA1c > 8.5 % Patients with adverse lipids in the screening visit who are not screened in fasting state (no food intake in the previous 8 hours) can still be included in the study if they provide a laboratory finding (not older than 6 months) from their physician or diabetologist with blood lipids in normal range. - Severe acute or chronic illness besides diabetes mellitus or history of any illness that, in the opinion of the Investigator, might confound the results of the study or pose additional risk in applying the medical device to the patient • Oncological diseases treated surgically, radiologically or by chemotherapy during the last 6 months • Acute myocardial infarction or apoplectic stroke during the last 6 months • Vascular surgery during the last 6 months • Severe liver dysfunction (GGT and GOT > upper limit of the normal range * 5) • Severe kidney dysfunction (GFR, calculated with the CKD-EPI formula < 30 ml/minute) • Significant abnormalities of the blood count, e.g. thrombocytopenia, leucopenia, anaemia • Febrile infection - Pregnancy or lactation period - Positive results of HIV, Hepatitis B and Hepatitis C tests - Coagulation defect / bleeding disorder assessed by prothrombin test (Quick/INR) - Receiving anti-coagulants with the exception of acetylsalicylic-acid (“Aspirin”), Ticlopidine, Clopidogrel - Intake of acetaminophen - Manifest severe late complications of diabetes mellitus, e.g. severe macroangiopathy and microangiopathies: severe neuropathy, severe retinopathy or severe nephropathy - Severe allergic reactions, e.g. to plaster as determined by the responsible physician - History of frequent catheter abscesses associated with pump therapy - Alterations of the adipose tissue around the planned insertion sites, e.g. lipodystrophy - Significantly impaired awareness of hypoglycemia - Implanted active medical devices - Severe skin abnormalities or skin diseases, e.g. psoriasis vulgaris, at the potential sensor insertion sites - Mental incapacity or language barriers precluding adequate compliance with the study procedures - Legal incompetence or limited legal competence - Dependency from the sponsor or the clinical investigator (e.g. co-workers of the sponsor or the study site or their families)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of incidence of deviations between tissue glucose and blood glucose readings based on Leelarathna et al. (Evaluating the Accuracy and Large Inaccuracy of Two Continuous Glucose Monitoring Systems. Diabetes Technology and Therapeutics 15 (2013):143-149) | — |
Secondary
| Measure | Time frame |
|---|---|
| MARD Percentage of results within ISO 15197 limits Consensus Error Grid PARD Mean relative difference Time lag Prediction quality of trend indicators | — |
Countries
Germany
Contacts
Public ContactGuido Freckmann
Institut für Diabetes-Technologie, Foschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
Outcome results
None listed