Evaluation of the efficacy and safety of a new Continuous Glucose Monitoring System in adult patients with type 1 and type 2 diabetes

Not Applicable

Completed

• Conditions: Type 1 Diabetes; Type 2 Diabetes; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12622000290796
• Lead Sponsor: i-SENS, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-02-15
• Study Completion: 2023-07-12
• Last Update Posted: 21 August 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 69

Inclusion Criteria

1.Adults who are 18 years of age or above
2.Patients with type 1 and type 2 diabetes who use intensive insulin therapy with known dosing parameters and at least one of the following two options of insulin requirements:
-at least 2 injections daily, or
-at least 0.2 units of insulin/kg/day
3.Patients who voluntarily decide to participate in the study and provide written informed consent

Exclusion Criteria

1.Potential subjects older than 45 years with more than 2 further cardiovascular risk factors (see factors a-c below) will be excluded from study entry:
a.)Smoker
b.)Arterial hypertension (greater than 150 / 80 mmHg)
c.)HbA1c greater than 9.0 %
2.Patients with the following uncontrolled abnormal skin/skin diseases at the CGM sensor attachment site: Severe psoriasis, recent burn injury or severe sunburn, severe eczema, severe scar, extensive tattoo, dermatitis herpetiformis, severe rash, Staphylococcus aureus infection, etc.
3.Patients with moderate/severe allergic contact dermatitis to medical adhesives
4.Patients with severe hypoglycemia events within 6 months prior to screening
Severe hypoglycemia: Loss of consciousness or seizure requiring emergency medical treatment due to hypoglycemia
5.Patients with more than 1 episode of diabetic ketoacidosis within the past 6 months prior to screening
6.Patients with cerebrovascular diseases or the following cardiovascular diseases (but not limited to) when instable (defined by event or increasing symptoms in the last 6 months) or with insufficient therapy:
Ischemic heart disease, peripheral vascular disease, cardiomyopathy, congenital heart disease, serious arrhythmia, etc.
7.Patients with epilepsy, syncope, or adrenal disorders within 6 months prior to screening
8.Patients with chronic infectious disease
9.Patients with anemia (hemoglobin below laboratory determinded normal range for age and sex).
10.Patients scheduled for unchangeable X-ray, MRI, or CT during the study
11.Pregnant, lactating women or those who plan to become pregnant or do not agree to use an adequate method of contraception during the study
12.Patients who are currently participating or participated within 2 weeks prior to screening in another study or plan to participate in another study that in the opinion of the investigator would affect the safety of the study subject or the study result
13.Patients unwilling to abstain from use of nutritional supplements containing xylose
14.Patients with cognitive impairment or who are not suitable for this study or may be at increased risk associated with study participation in the opinion of the investigator
15.Wearing of a pace maker or other comparable medical devices
16.Dependency from the sponsor or the clinical investigator
17.Hypoglycemia unawareness
18.History of frequent catheter abscesses associated with pump therapy

Study & Design

• Study Type: Interventional
• Study Design: Not specified