NCT02733991CompletedNot Applicable
Study of MiniMed™ 640G Insulin Pump With SmartGuard™ in Prevention of Low Glucose Events in Adults With Type 1 Diabetes
Medtronic Diabetes14 sites in 4 countries153 target enrollmentStarted: December 1, 2016Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Medtronic Diabetes
- Enrollment
- 153
- Locations
- 14
- Primary Endpoint
- Mean Number of Sensor Glucose Hypoglycaemic Events Below or Equal to 55 mg/dL Per Patient/Week.
Study Overview
Brief Summary
A premarket, international multicenter, prospective, open label, adaptive, randomized controlled study.
The aim is to evaluate the efficacy of sensor augmented pump therapy with MiniMed™640G and SmartGuard™in preventing hypoglycemic events in comparison with continuous subcutaneous insulin infusion therapy in type 1 diabetes adults with an increased risk of hypoglycemia. The primary objective is to demonstrate a reduction in the mean number of hypoglycemic events when using the MiniMed™640G system with SmartGuard™ and the secondary objectives will aim at evaluating the difference in glycemic parameters and HbA1c.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 24 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 24-75 years old at time of screening.
- •Diagnosed with Type 1 diabetes ≥10 years prior to screening.
- •On pump therapy for ≥ 6 months prior to screening.
- •Not on Real Time continuous glucose monitoring for ≥ 3 months prior to screening.
- •HbA1c value ≥5.8% and ≤10.0% as assessed by local lab ≤ 15 days prior to screening or performed at screening.
- •A documented Severe Hypoglycemia event ≤ 12 months prior to screening, OR Clarke score ≥4 assessed at time of screening, OR
- •Gold score ≥4 assessed at time of screening.
- •Subject is willing to sign and date informed consent, comply with all study procedures and wear all study devices as required during the study.
Exclusion Criteria
- •Untreated Addison's disease, thyroid disorder, growth hormone deficiency, hypopituitarism or definite gastroparesis, per investigator judgment.
- •Subject is using Pramlintide (Symlin) SGLT2 inhibitor, GLP agonist at time of screening.
- •Renal failure defined by creatinine clearance <30 ml/min, as assessed by local lab test ≤ 3 months before screening or performed at screening at local lab.
- •Hearing or vision impairment hindering perception of glucose display and alarms, or otherwise incapable of using the study devices, per investigator judgment.
- •Current pregnancy or intention to conceive.
- •Any unresolved adverse skin condition in the area of sensor placement (e.g. psoriasis, rash, Staphylococcus infection).
- •Alcohol or drug abuse, other than nicotine, per investigator judgment.
- •Any other disease or condition that may preclude the patient from participating in the study, per investigator judgment.
- •Legally incompetent, illiterate or vulnerable person.
- •Randomization Criteria:
- •If subjects meet the above criteria, as well as all of the following criteria assessed at the end of the run-in period, they may continue to participate in the treatment period of the study:
- •Subject has worn two weeks the sensor with transmitter during the run-in period.
- •Subject has shown acceptable tolerance of sensor wear, per investigator judgment.
- •Subject performed ≥ 4 finger stick blood glucose measurements daily, as determined by CareLink™ Clinical data upload as the mean number of SMBG/day over the past 14 days (SMBG number / day ≥ 3.5 rounds up to 4).
- •Subject showed ability to comprehend the pump training and study procedures, per investigator judgment.
Arms & Interventions
Treatment
Experimental
MiniMed™640G and Suspend before Low feature of SmartGuard™ turned on.
Intervention: MiniMed™640G and Suspend before low (Device)
Control
Active Comparator
MiniMed™640G alone
Intervention: MiniMed™640G (Device)
Outcomes
Primary Outcomes
Mean Number of Sensor Glucose Hypoglycaemic Events Below or Equal to 55 mg/dL Per Patient/Week.
Time Frame: 6 months
Secondary Outcomes
- Mean Time Spent of Sensor Glucose Values Within Range and Including 70-180 mg/dL.(6 months)
- Mean Time Spent of Sensor Glucose Values Below or Equal 55 mg/dL.(6 months)
Investigators
Study Sites (14)
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