A Pilot Study Examining the Efficacy of a Support Algorithm for Commencing Patients with Type 2 Diabetes on a Basal / Prandial Insulin Regimen in the Primary Care Setting With Professional Continuous Glucose Monitoring as an Adjunct.

Phase 4

Recruiting

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

• Registration Number: ACTRN12610000797077
• Lead Sponsor: Sanofi Aventis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-09-24
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 144

Inclusion Criteria

Type 2 diabetes patients who are insulin naive. Age>18 Years<80 Years. At least 2 oral hypoglycaemic agents (metformin, sulphonylurea, Thiazolidindiones) at maximal tolerated doses, or in the opinion of the responsible medical practitioner, insulin is deemed necessary if the patient is on less than 2 oral hypoglycaemic agents. The doses of the oral hypoglycaemic agents should be stable for at least 3 months prior to enrollment into the study. Haemoglobin A1c(HbA1c)>7.0%. Willing to monitor glucose levels at least twice daily. Willing to commence insulin and comply with follow-up.

Exclusion Criteria

Type 1 diabetes.
Evidence of satisfactory fasting glucose levels (mean <6.0mmol/L) with post-prandial hyperglycaemia (mean >10.0mmol/L).
Previous or current treatment with insulin (excluding the short term (<2weeks) use of insulin in acute illness or during hospitalization).
Non-English speaking.
Significant cognitive impairment.
Impaired vision or any other physical handicap precluding reliable glucose monitoring administration of insulin.
Significant renal impairment: estimated glomerular filtration rate (egfr)< 20.
Any recent (<3months) or ongoing life-threatening illness.
Needle phobia.
Pregnancy or planned pregnancy.
Major psychiatric disorder.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The aim of the proposed study is to evaluate a model of care for the initiation and titration of basal and then prandial insulin, as required, guiding general practitioners and their practice nurses in a workplace setting. The primary outcome is to be the change in Haemoglobin A1c (HbA1c) at 12 and 24 weeks compared with baseline.[12 weeks and 24 weeks from baseline]