Status:
COMPLETED
Study of MiniMed™ 640G Insulin Pump With SmartGuard™ in Prevention of Low Glucose Events in Adults With Type 1 Diabetes
Lead Sponsor:
Medtronic Diabetes
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
24-75 years
Phase:
NA
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 Smar...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2018
Estimated Enrollment :
153 Patients enrolled
Trial Details
Trial ID
NCT02733991
Start Date
December 1 2016
End Date
October 1 2018
Last Update
January 21 2020
Active Locations (14)
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1
CHU de Besançon
Besançon, France
2
CHU Grenoble
Grenoble, France
3
APHM - La Conception
Marseille, France
4
CHU Montpellier - Hôpital Lapeyronie
Montpellier, France