Seven Day Study of a Combined Insulin Cannula and Glucose Sensor Delivering Basal and Bolus Insulin in Persons with Type 1 Diabetes

Not Applicable

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

• Registration Number: ACTRN12619001295134
• 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: 2019-09-19
• Last Update Posted: 30 September 2019

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

1. T1D, of at least 6 months duration.
2. Age 21-75
3. Insulin pump usage at the time of screening and for at least 3 months prior to screening.
4. HbA1c between 5.8 and 10%
5. Willingness and ability to follow all study procedures and to attend all clinic visits.

Exclusion Criteria

1. Chronic kidney disease as defined by estimated-GFR < 45 ml/min
2. Inadequately-treated proliferative diabetic retinopathy
3. Inability to read pump or CGM display due to reduced visual acuity
4. Presence of unstable ischaemic heart disease or myocardial infarction within the last 3 months.
5. Cerebrovascular disease causing permanent physical or cognitive limitation
6. Chronic liver disease with synthetic deficiency (defined as serum albumin of <3.3 g/dl, or serum total bilirubin exceeding 2.5 mg/dl)
7. Any active foot ulcer
8. Known active infection such as HIV or hepatitis
9. Active malignancy, except for basal or squamous cell skin cancer
10. Anaemia defined by HCT at least 4 percentage points below lower limit of the reference range
11. History of cardiac arrhythmia (note: PVC’s numbering < 6 per minute are not exclusionary)
12. Dementia
13. Schizophrenia or other untreated mental illness
14. Chronic substance abuse
15. Seizure disorder
16. Major surgical operation within 30 days prior to screening
17. Bleeding disorder, or treatment with anticoagulants
18. Allergy to Lispro insulin
19. Allergy to acrylate-based skin adhesives
20. Use of an investigational drug or device in the last 30 days
21. Female of childbearing potential who is pregnant or intending to become pregnant or breast-feeding, or is not using adequate contraceptive methods.
22. Diabetic ketoacidosis or major hypoglycemia within the last 6 months
23. Insulin resistance as defined by insulin requirement of more than 200 units per day
24. Use of glucose-lowering medications other than insulin
25. Need for uninterrupted treatment with acetaminophen
26. Any other physical or mental condition judged by the PI as being exclusionary.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Experimental device CGM sensor accuracy as determined by mean absolute difference (MAD) between experimental device sensor readings and reference YSI venous whole blood glucose values <75mg/dL and mean absolute relative difference (MARD) for reference YSI venous whole blood glucose values >75mg/dL during mixed meal testing with frequent venous blood sampling. [ 1 day and 7 days post post commencement of intervention during mixed meal testing with blood collected every 15 minutes for 6hrs. <br>]

Secondary Outcome Measures

Name	Time	Method
nexplained glycaemic excursions requiring a cannula change. Indicated by SMBG confirmed hyperglycaemia BGL>13.9mmol/L not responding to correction insulin boluses suggesting experimental device cannula blockage or failure. [Throughout 7 day period post intervention commencement. Participants will be asked to assess SMBG BGL levels at least 4 times per day.];Mean scores on scales assessing subjective participant perceptions and discomfort. Assessed by Tolerability Questionnaire completed by participants.[Day 1 and day 7 post intervention commencement. ];Objective changes reflecting skin reactions at site of experimental device insertion. Assessed by Draize Scale completed by research staff.[Day 1 and 7 post intervention commencement.]