NCT02082184CompletedNot Applicable
Randomised Controlled Study to Evaluate the Impact of Novel Glucose Sensing Technology on HbA1c in Type 2 Diabetes
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Abbott Diabetes Care
- Enrollment
- 302
- Locations
- 49
- Primary Endpoint
- HbA1c at 6 Months
Study Overview
Brief Summary
To evaluate the impact of the Abbott Sensor Based Glucose Monitoring System on glycaemic control (HbA1c) compared to Self Monitoring Blood Glucose (SMBG) testing using a randomised controlled study design in adults with Type 2 diabetes using insulin.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Has Type 2 diabetes on insulin therapy for ≥ 6 months and on their current regimen for ≥3 months prior to study entry.
- •Their insulin management must be one of the following;
- •an injection regimen of prandial insulin at least once daily,
- •or, prandial insulin at least once daily plus basal insulin at least once daily,
- •or, continuous subcutaneous insulin infusion (CSII) with no plans to change during the study.
- •HbA1c result ≥7.5% (58 mmol/mol) and ≤12.0% (108 mmol/mol) on entry to the study.
- •Reports self-testing of blood glucose levels on a regular basis equivalent to a minimum of 10 tests per week, for at least 2 months prior to study entry.
- •In the investigator's opinion the subject is considered technically capable of using the Abbott Sensor Based Glucose Monitoring System.
- •In the Investigator's opinion the subject is proactive and therefore willing to modify their diabetes management
- •Aged 18 years or over.
Exclusion Criteria
- •Insulin regimen consists entirely of basal or includes bi-phasic insulin.
- •Subject is currently prescribed animal insulin.
- •Subject is currently prescribed steroid therapy or is likely to require steroid therapy for any acute or chronic condition during the study.
- •Has known allergy to medical grade adhesives.
- •Currently participating in another device or drug study that could affect glucose measurements or glucose management.
- •Currently using a Continuous Glucose Monitoring (CGM) device or has used one within the previous 4 months.
- •Is planning to use a CGM device at any time during the study.
- •Total daily dose of insulin (TDD) is >1.75iu/kg at entry to the study.
- •A female subject who is pregnant or planning to become pregnant within the study duration.
- •Currently receiving dialysis treatment or planning to receive dialysis during the study.
- •Has experienced an acute myocardial infarction within previous 6 months.
- •Has a concomitant disease or condition that may compromise patient safety, including unstable coronary heart disease, cystic fibrosis, serious psychiatric disorder, or any other uncontrolled medical condition.
- •Has a pacemaker or any other neuro stimulators.
- •Has experienced any episode of severe hypoglycaemia, requiring third party assistance and/or admission to hospital, in the previous 6 months.
- •Has experienced any episode of diabetic ketoacidosis (DKA) or hyperosmolar hyperglycaemic state (HHS) in the previous 6 months.
- •In the investigator's opinion, the subject is considered as unsuitable for inclusion in the study for any other reason.
Outcomes
Primary Outcomes
HbA1c at 6 Months
Time Frame: Baseline and Day 194
Difference in HbA1c between intervention and control group at day 194 adjusting for baseline HbA1c at day 1 using ANCOVA.
Secondary Outcomes
- Number of Glucose Measurements Performed(Days 15 to 208)
- System Utilisation(Days 15 to 208)
- Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc) Scores From Day 1 to Day 194.(Baseline and Day 194)
- Time in Range(Baseline and Days 194 to 208)
- Time Spent <70 mg/dL and <55 mg/dL(Baseline and Days 194 to 208)
- Frequency of Episodes <70 mg/dL and <55 mg/dL(Baseline and Days 194 to 208)
- Time Spent >180 mg/dL and >240 mg/dL(Baseline and Days 194 to 208)
Investigators
Study Sites (49)
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