FLASH-CGM – investigating the effect of flash glucose monitoring on glycaemic profile in patients with insulin-treated type 2 diabetes in the post-discharge setting; a randomized pragmatic trial

Not Applicable

Recruiting

• Conditions: Diabetes; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12621001661864
• Lead Sponsor: Blacktown Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-12-02
• Last Update Posted: 6 December 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1.Age 18-80 years of age
2.Have a diagnosis of type 2 diabetes mellitus with (HbA1c > 6.5%).
3.Utilizing insulin
4.Attending the diabetes discharge clinic at Blacktown Hospital

Exclusion Criteria

Individuals with: Type 1 diabetes; pregnant or planning pregnancy; significant alcohol or drug abuse; severe/untreated mental health illnesses, including eating disorders; advanced cardiac, liver or renal disease, Type 2 diabetes not using insulin.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time in range as assessed using the fCGM and CGM systems described prior. The optimum glucose range specified for these devices is 4-10.[3 months post-intervention commencement, continuously monitoring blood glucose (FCGM measures glucose every 5 minutes)]

Secondary Outcome Measures

Name	Time	Method
HbA1c assessed by blood test[Baseline and 3 months post-intervention commencement];eGFR assessed by blood test[Baseline and 3 months post-intervention commencement];BMI assessed by weight/height of patient collected in clinics[Baseline and 3 months post-intervention commencement];Hypo/hyperglycemia assessed using sensor downloads[Baseline and 3 months post-intervention commencement];Lipids assessed using blood tests[Baseline and 3 months post-intervention commencement];Diabetes distress assessed using the Diabetes Distress Score[Baseline and 3 months post-intervention commencement];Healthcare utilization assessed using routine hospital data[Baseline and 3 months post-intervention commencement];Cost of healthcare assessed using routine hospital data[Baseline and 3 months post-intervention commencement]