Evaluation of a Novel Continuous Glucose Monitoring System in Children and Adults with Type 1 and Type 2 Diabetes

Not Applicable

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

• Registration Number: ACTRN12624000735550
• Lead Sponsor: i-SENS, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-14
• Last Update Posted: 24 June 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1.Children and adolescents who are 7 to 17 years of age (inclusive).
2.Adults who are 18 years of age or older.
3.Participants with type 1 diabetes, or with type 2 diabetes and on more than one anti-diabetic medication.
4.Participants who voluntarily decide to participate in the study and provide written informed consent.

Exclusion Criteria

1.Potential participants older than = 45 years with more than 2 further cardiovascular risk factors (see factors a-c below) will be excluded from study entry:
a.)Current Smoker.
b.)hypertension (>150 / 80 mmHg).
c.)HbA1c > 9.0 %.
2.Participants with the following uncontrolled abnormal skin/skin diseases at the CGM sensor attachment sites including but not limited to:
•Severe psoriasis, recent burn injury or severe sunburn, severe eczema, severe scar, extensive tattoo, dermatitis herpetiformis, severe rash and Staphylococcus aureus infection.
3.Participants with moderate/severe allergic contact dermatitis to medical adhesives.
4.Participants with severe hypoglycemia events within 6 months prior to screening. Severe hypoglycemia refer to loss of consciousness or seizure requiring emergency medical treatment due to hypoglycemia
5.Participants with >1 episode of diabetic ketoacidosis within the past 6 months prior to screening.
6.Participants 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 including but not limited to:
•Ischemic heart disease, peripheral vascular disease, cardiomyopathy, congenital heart disease and serious arrhythmia.
7.Diagnosis of epilepsy or adrenal disorders, or episode/s of syncope within 6 months prior to screening.
8.Participants with chronic infectious disease.
9.Participants with anemia (hemoglobin below laboratory-determined normal range for age and sex).
10.Participants scheduled for unchangeable X-ray, Magnetic resonance imaging, or computed tomography scan during the study.
11.Pregnant or lactating women. Urine pregnancy test screening to be conducted on all pre-menopausal women.
12.Participants who are currently participating or participated within 2 weeks before 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 participant or the study results.
13.Participants unwilling to abstain from use of nutritional supplements containing xylose.
14.Participants 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 pacemaker or other comparable medical devices.
16.Employees or family members of the sponsor or the clinical investigator.
17.History of frequent catheter abscesses associated with pump therapy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
%20/20 accuracy of nCGM[Determined by comparing the % of nCGM values within ±20% of Comparator Method 1 (capillary blood glucose; CM1) values at capillary blood glucose levels greater than or equal to 5.55 mmol/L (100 mg/dl) or within ±1.11 mmol/L (20 mg/dl) of CM1 values at venous blood glucose levels less than 5.55 mmol/L (100 mg/dl) (%20/20) End of study on day 23 post-intervention commencement]