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) .

INTERVENTION: 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. 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 fur 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. CONDITION: Hypoglycaemia in elderly type two Diabetes Mellitus patients on premixed insulin treatment Type two Diabetes Mellitus PRIMARY OUTCOME: ‐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. SECONDARY OUTCOME: 10‐Assesstime spent in hypoglycemia during night time (24:00 ‐06:00 am ) in the two interventions ; 2‐Assess number of episodes of hypoglycemia using the CGM data and documented self monitored blood glucose finger bricks . 4‐Assess morbidity data including cardiac events, frequency of hospital admissions due to hypoglycaemic episodes, falls and fall related complications in the two interventions as a composite end point . Assessment will be done using medical records and self reported events by the participants . 5‐Assess patient QOL in the two interventions. ; 6‐Assess HBA1C in the two interventions using a serum blood test 7‐Assess Fructosamine in the two interventions using a serum blood test 8‐Assess time spent in hypoglycemia during day time (06:00 am –24:00) in the two interventions using CGM data Assess insulin requirements (total daily dosage) for the two interventions, assess basal and prandial insulin requirements in the basal plus arm . ; Assessment will be done using the daily insulin administration reported by the participants and recorded in the blood sugar booklet Assess number of symptomatic hypoglycemia episodes in the two interventions. will be assessed using the medical records and direct reporting from the patients during the study visits Assess percentage of time spent in blood glucose target range in the two interventions using the continuous glucose monitoring CGM analysis of variability and peaks (MAGE and SD ) between the two interventions using CGM data that will be done twice during the study period Incidence of hypoglycemia episodes <3.9mmol/l, 3.1 mmol/L and <2.0mmol,as assessed by Self Monitored Blood Glucose (SMBG) Incidence of hypoglycemia episodes <3.9mmol/l, 3.1 mmol/L and <2.0mmol,as assessed by Self Monitored Blood Glucose (SMBG). ; ; This outcome will be assessed during the 12 weeks treatment period using the daily blood sugar booklet at the end of the 12 weeks period Number of severe episodes of hypoglycemia assessed by requiring third party assistance or associated with a loss of consciousness or severe consequences. ; This outcome will be assessed by direct reporting of the participants on each visit and by regular check of the medical records during the study period INCLUSION CRITERIA: 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