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) .

Visit 1 : 1.Dietary history, Dietician review and education for healthy lifestyle and eating. Subjects will not be asked to perform complex carbohydrate counting, but will receive a standard healthy meal plan appropriate for age and activity, containing moderate amounts of regularly-spaced carbohydrates, weighted towards the morning and evening meals. (30 minutes one to one session) 2.Diabetes educator review to ensure uniformity of blood glucose monitoring and insulin injection technique and review (30 minutes one to one session) 3.Supply of Self monitored blood glucose meter ,blood glucose strips and blood glucose record booklet. Participants will be requested to record blood sugar level four times a day for a week (Before meals and before bed) 4.Supply of dietary diary book to record all dietary intake for one week. 5.Participants will undergo Diabetes Quality of Life Questionnaire, which has been validated for the use in T2DM patients.. Visit 2, Follow up visit in one-week time: 1. Participants who showed consistency in recording blood sugar levels and dietary intake as requested would undergo seven consecutive days of CGM (Medtronic, Registered Trademark). This CGM system does not reveal blood glucose results in real-time to either the wearer or clinician. CGM device will be inserted subcutaneously at the clinic. Participants will also continue to record their Blood glucose levels and dietary intake in week 2 2. All participants will continue during this first CGM week on their preexisting twice-daily pre mixed insulin. 3. Participants will be booked for visit at day 7 of CGM insertion for removal of the CGM. Visit 3, one-week time from visit 2 1.Following removal of CGM, results will be reviewed by an independent health professional not otherwise involved in the study analysis to ensure that there are no recorded severe hypoglycaemic episodes (Interstitial glucose <2.5 mmol/L at any time). 2.Participants who show evidence of severe hypoglycaemia on CGM will have CGM results unblinded to the investigators for further management and insulin adjustment. They will remain in the study. In all other cases, investigators will not know the results of initial CGM until the conclusion of the study. 3.Participants will be randomized from the time of this visit by allocating the next available randomization number to the participant and allocating a treatment sequence using a computer-generated code. Stratification will be done based on two criteria, HbA1c (6.5-8.4 and 8.5 -10) and age (65-75 and >75). 4.42 Participants will be randomised to each arm, one arm will continue on their pre-existing twice daily premixed insulin and the other arm will be allocated to Basal insulin glargine plus two bolus insulin glulisine injections with the two main meals . Patients who will require different Basal Bolus regimen due to their different dietary requirements will be allowed to switch to Basal plus either 1, 2 or maximum 3 boluses of Insulin during the titration phase. 5.Insuline dosages will be decided by the principal or co investigators who are Endocrinologists or Endocrinology registrars . Insulin Glargine initial dose will be 80% of the total units per day of intermediate insulin portion of their current premixed insulin. 6.Insulin Glargine dose will represent 1/3 to 1/2 of the total daily insulin requirements for participants switched to the basal bolus regimen depending on their dietary pattern and carbohydrate intake. 7.The remaining insulin requirements will be provided as two boluses of Insulin Glulisine with the two main meals aiming for two injection times per day where one bolus will be injected with one of the two main meals and the other bolus injection will be injected at the same time as the basal insulin with the other main meal, however participants will be allowed to switch to either one, two or three boluses of insulin depending on their dietary need. 8.On the same visit, participants who have been randomized to basal plus regimen arm will undergo an educational session one to one by Dietician and Diabetic educator for one hour to discuss meal plans and insulin plan for their new regimen. 9.Participants will be requested to attend four weekly visits for stabilization and optimization of blood glucose level control aiming for fasting blood glucose level of 4-8 mmol/l and postprandial blood glucose level of 6-12 mmol/l. 10.The participants will be allowed to continue with their current stable doses of oral hypoglycaemic medications throughout the whole study period. Visit 4, 5, 6 and 7, four weeks Stabilization period for both arms 1.Weekly visit for individualised optimization of blood glucose level aiming for a target fasting blood glucose level of 4-8 mmol/l and postprandial level of 6-12 mmol/l. 2. Participants who are progressing satisfactorily towards target within the four week period will be managed in the community with a dose titration plan for their insulin for a further 12 week treatment period for each arm and to be reviewed in 12 weeks’ time. 3.Participants who have ongoing poor blood glucose control or hypoglycaemia after 4 weeks will undergo continued weekly review until levels are stabilised.Those extended weekly review will be during the 12 weeks treatment period. which is fixed period to all participants. Treatment period, 12 weeks' community based period: 1.Participants in both arms will continue to record their self-monitored blood glucose level 4 times a day during the 12 weeks treatment period. 2.Participants will be encouraged to contact the research team for phone advice regarding their Diabetes management and insulin dose titration 3.Participants will be requested to return to the University and research centre clinic at the end of week 12 to repeat CGM Visit 8, End of treatment period visit and scheduled repeated unblinded CGM: 1. All Participants will repeat the Diabetes Quality of Life Questionnaire 2. CGM will be inserted for a planned 7 consecutive days 3. Participants will continue to record their self-monitored blood glucose level plus dietary intake during the CGM week period, and to maintain a similar lifestyle to their first CGM period. 4.Participants will continue during this week on their randomly allocated treatment Visit 9, Final visit: 1.CGM removal and reviewing dietary and self-monitored blood glucose levels 2.Repeating HbA1c, Fructosamine, Full blood count , Liver function test and kidney function test. 3.Participants will be allowed by the end of this visit to choose their preferred insulin regimen; participants who will choose to continue on Basal Bolus regimen will continue to have their insulin supplied through subsequent GP management and prescription.