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Clinical Trials/ACTRN12619001295134
ACTRN12619001295134
Not yet recruiting
未知

Clinical trial of device to evaluate the accuracy of an experimental continuous glucose monitor (CGM) measuring glucose continuously in the immediate vicinity of subcutaneous insulin delivery in people with type 1 diabetes (T1D) on insulin pump therapy.

St Vincent's Hospital Melbourne0 sites12 target enrollmentSeptember 19, 2019
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Conditionstype 1 diabetesMetabolic and Endocrine - Diabetes

Overview

Phase
未知
Intervention
Not specified
Conditions
type 1 diabetes
Sponsor
St Vincent's Hospital Melbourne
Enrollment
12
Status
Not yet recruiting
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 19, 2019
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
St Vincent's Hospital Melbourne

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

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