A Phase 4 interventional study of Insulin Pump and Multiple daily injections of insulin in Type 2 Diabetes Mellitus, sponsored by Clinical Research Centre, Malaysia. Status unknown at 1 site in Malaysia. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-04-13.
Sponsored by Clinical Research Centre, Malaysia · Phase 4, Interventional, and Treatment
The purpose of this study is to evaluate the comparative efficacy of insulin pump therapy versus multiple daily injections in insulin-taking type 2 diabetes mellitus who are sub-optimally controlled with premixed insulin regimen. This research is necessary because many patients with type 2 diabetes mellitus do not meet their glucose targets.
In advanced Type 2 diabetes mellitus, many patients develop worsening diabetes control and unable to reach the glucose targets despite intensive insulin regimens.This is further complicated by the risks of low blood sugar and weight gain. These limitations of multiple daily injection treatment show the need for new treatments for this group of patients.
This study evaluates between group change in glycemic control (HbA1c) after 6 months of insulin pump therapy in patients with type 2 Diabetes Mellitus, as compared to patients on multiple daily injections (MDI) therapy over the same time period. It also evaluates between group changes in diabetes clinical outcomes after 6 months in patients with type 2 DM. Patient related outcomes will be measured after 6 months of therapy. The primary endpoint will be between group difference in average HbA1c changes from baseline to 6 months, when comparing Continuous Subcutaneous Insulin Infusion (CSII) to MDI.
The secondary end point concerns the safety issues such as severe hypoglycemia incidence: defined as an episode absolutely requiring assistance from another person and preferably accompanied by a confirmatory blood glucose by finger stick of less than 50mg/dL (2.8 mmol/L), (i.e., subject is unable to treat self and requires carbohydrate, glucagon or other resuscitative actions to prevent further clinical deterioration), hospitalizations, Diabetic Ketoacidosis (DKA), an acute metabolic complication of diabetes, characterized by hyperglycemia, hyperketonemia, and metabolic acidosis, within group difference in HbA1c from 6 months to 12 months, change in weight or BMI, change in Lipids : total cholesterol, high density lipoprotein(HDL),low density lipoprotein(LDL),triglyceride, change in blood pressure, Insulin Dosage Changes (Total Daily Dose), Number of self monitoring blood glucose (SMBG)/day, treatment satisfaction: Diabetes Treatment Satisfaction Questionnaire status and change version (DTSQs and DTSQc).
The hypotheses underlying the secondary outcomes : the pump therapy improves glycaemic control whilst utilizing less total daily dose of insulin in comparison to multiple daily injections of insulin. This is associated with parallel improvement in metabolic profiles such as blood pressure and lipids. As for the glucose monitoring, investigators want to evaluate whether there is any difference in the frequency of SMBG/day between the 2 treatment groups. More frequent SMBG monitoring denotes better compliance, motivation and empowerment by the participants to control their diabetes.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's planned enrollment of 118 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Clinical Research Centre, Malaysia is the lead sponsor of 28 studies on the registry; 5 are open to participants now.
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CRITERIA FOR INCLUSION AT SCREENING
CRITERIA FOR INCLUSION AT RANDOMISATION
Exclusion Criteria:
CRITERIA FOR EXCLUSION (AT SCREENING AND RANDOMISATION)
Subject has
Medtronic Minimed Paradigm Veo Insulin Pump utilising rapid acting insulin Glulisine or Aspart
Device: Insulin Pump · Drug: Multiple daily injections of insulin
Multiple daily injections consisting of a single basal insulin injection(Glargine) and 3 bolus insulin injections (rapid acting insulin Glulisine or Aspart) before each meal
Device: Insulin Pump · Drug: Multiple daily injections of insulin
Medtronic Minimed Paradigm Veo Insulin Pump
Multiple daily injections which consist of a single injection of basal insulin(insulin Glargine) and 3 injections of bolus insulin(rapid acting insulin Glulisine or Aspart) before each meal
Also known as: Basal bolus injections of insulin
between group difference of HbA1c changes from baseline to 6 months
Between group difference in HbA1c changes from baseline to 6 months, when comparing CSII to MDI
Time frame: 6 months
Within group difference in HbA1c changes from 6 months to 12 months
Within group difference in HbA1c changes from 6 months to 12 months after cross-over from MDI to CSII
Time frame: 1 year
Safety endpoints which are 1) Number of events of severe hypoglycemia 2)Any hospitalizations for hypoglycaemia or hyperglycaemic emergencies 3)Number of events of Diabetic Ketoacidosis (DKA)
1. Number of events of severe hypoglycemia : defined as an episode absolutely requiring assistance from another person and preferably accompanied by a confirmatory blood glucose by finger stick of less than 50mg/dL (2.8 mmol/L), (i.e., subject is unable to treat self and requires carbohydrate, glucagon or other resuscitative actions to prevent further clinical deterioration) 2. Any hospitalizations for hypoglycaemia or hyperglycaemic emergencies 3. Number of events of Diabetic Ketoacidosis (DKA), an acute metabolic complication of diabetes, characterized by hyperglycemia, hyperketonemia, and metabolic acidosis
Time frame: 1 year
change in weight (kg)
Between and within group difference in average weight changes when comparing CSII to MDI
Time frame: 1 year
Number of Self Monitoring Blood Glucose (SMBG) per day
Between and within group difference in the number of SMBG per day between CSII and MDI. The data is downloaded using Bayer Glucofacts Deluxe Software from the glucometer during each visit.
Time frame: 1 year
Total Daily Insulin Dosage per day in Unit/day
Between and within group total daily insulin dosage per day in Unit/day between CSII and MDI. The total daily insulin dose per day in the CSII group is downloaded from Medtronic CareLink Therapy Management Software whereas for the MDI group, it is the cumulative dosage of total insulin per day.
Time frame: 1 year
Total Daily Insulin Dosage per body weight in kilograms per day (Unit/kg/day)
Between and within group total daily insulin dosage per day (Outcome 6) divide by body weight in kilograms (Outcome 8) measured as (Unit/kg/day) for each patient,comparing between CSII and MDI
Time frame: 1 year
Body weight in kilograms
Between and within group body weight in kilograms, comparing between CSII and MDI
Time frame: 1 year
Treatment satisfaction using Diabetes Treatment Satisfaction Questionnaire DTSQs
Treatment satisfaction: Diabetes Treatment Satisfaction Questionnaire using DTSQs comparing between CSII and MDI
Time frame: 1 year
Plan to share: No
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Clinical Research Centre, Malaysia