Evaluation of a Medtronic extended-life glucose sensor in people with diabetes

Not Applicable

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

• Registration Number: ACTRN12620001161910
• Lead Sponsor: St Vincent's Hospital Melbourne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-05
• Last Update Posted: 16 November 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Participants will be considered for inclusion in the study if they meet all the following criteria:
1. Participant is over 18 years of age at time of screening.
2. A clinical diagnosis of Type-1 Diabetes, as determined by the Investigator.
3. Participant is using insulin to treat his/her Diabetes.
4. Currently using a sensor or has experience with sensor use.
5. Preference will be given to subjects who have a history of hypoglycaemia.
6.Participant is willing to comply with all requirements associated with the protocol.

Exclusion Criteria

Participants will be excluded from the study for any of the following reasons:
1. Participant has a positive pregnancy screening test.
2. Any known allergies to glucocorticoid steroids
3. Participant is female and plans to become pregnant during the study.
4. Participant is unable to tolerate tape adhesive in the region of sensor placement.
5. Participant has any unresolved adverse skin condition in the region of sensor or device placement (e.g., psoriasis, rash, Staphylococcus infection).
6. Recent (< 3months) episode of severe hypoglycaemia or Diabetic ketoacidosis.
7. Known major life-threatening disease or psychiatric illness.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Accuracy of sensor glucose data performance provided by the Medtronic Extended Life glucose sensor (subcutaneously measured glucose) will be compared with meter glucose (blood glucose) and YSI glucose (plasma glucose) values obtained during meal tests as references.[Day 1, Day 2, Day 3, Day 7, Day 10 and Day 15 post-sensor insertion]

Secondary Outcome Measures

Name	Time	Method
Accuracy of sensor glucose data provided by the control sensor (subcutaneously measured glucose) compared with meter glucose (blood glucose) and YSI glucose (plasma glucose) values as references.[Day 1, Day 2, Day 3, Day 7, Day 10 and Day 15 post-sensor insertion];Sensor insertion site appearance on Day 17 of the Dexamethasone sensor and control nominal sensor.<br><br>[Day 17 post-sensor insertion];Plasma Dexamethasone levels at pre-specified study time-points[Day 1, Day 2, Day 3, Day 7, Day 10 and Day 15 post-sensor insertion]