Comparison of the incidence and duration of hypoglycaemia assessed by Continuous Glucose Monitoring (CGM) in elderly type 2 Diabetes patients treated with two different insulin regimens (long and short acting insulin VS premixed insulin) .

Phase 4

Recruiting

• Conditions: Type two Diabetes Mellitus; Hypoglycaemia in elderly type two Diabetes Mellitus patients on premixed insulin treatment; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12616001158459
• Lead Sponsor: Western Sydney Local Health District

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-08-25
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

1- T2DM patients
2- Age 65 year or older
3- On twice daily premixed Insulin
4-HbA1c at the time of enrolment: 6.5 to 10 %
5- On stable doses of oral hypoglycemic medications in the preceding 3 months before study enrolment

Exclusion Criteria

Exclusion Criteria:
1- T1DM Patients
2- Patients on long-term glucocorticoids or potential glucocorticoid treatment during the study period
3-Anemia or known history of significant haematological disorders
4-End stage renal disease on renal replacement therapy
5-End stage liver disease
6-Documented history of cognitive impairment or mental health disorders
7- History of severe and recurrent documented hypoglycemia.
8- Residents of high level aged care facilities
9-Active malignancy (other than Squamous cell carcinoma and basal cell carcinoma).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
-Compare the percentage of time spent in hypoglycemia, as determined by continuous glucose monitoring (percentage of time spent with interstitial glucose < 3.9 mmol/l during a 7 day CGM test) between the two interventions.[Primary outcome will be assessed at the end of study period following the second CGM assessment which will be at the end of visit 9 which is by the end of 7 days of the second CGM assessment (at the end of the 7 days following the 12 weeks treatment period)<br>CGM data will include the two CGM done during the study period]