Study of MiniMed™ 640G Insulin Pump With SmartGuard™ in Prevention of Low Glucose Events in Adults With Type 1 Diabetes

Not Applicable

Completed

Interventions: Device: MiniMed™640G and Suspend before low
Device: MiniMed™640G

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Treatment	MiniMed™640G and Suspend before low	MiniMed™640G and Suspend before Low feature of SmartGuard™ turned on.
Control	MiniMed™640G	MiniMed™640G alone

Primary Outcome Measures

Name	Time	Method
Mean Number of Sensor Glucose Hypoglycaemic Events Below or Equal to 55 mg/dL Per Patient/Week.	6 months

Secondary Outcome Measures

Name	Time	Method
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

Locations (14): Harrogate District Hospital
🇬🇧
Harrogate, N. Yorkshire, United Kingdom
Manchester Diabetes Center
🇬🇧
Manchester, United Kingdom
CHU de Besançon
🇫🇷
Besançon, France
CHU Grenoble
🇫🇷
Grenoble, France
APHM - La Conception
🇫🇷
Marseille, France
CHU Montpellier - Hôpital Lapeyronie
🇫🇷
Montpellier, France
Ospedale Papa Giovanni XXIII
🇮🇹
Bergamo, Italy
Ospedale S. Raffaele
🇮🇹
Milan, Italy
Ospedale S. Gionanni di Dio
🇮🇹
Olbia, Italy
UMC Utrecht
🇳🇱
Utrecht, Netherlands
Groene Hart Ziekenhuis
🇳🇱
Gouda, Netherlands
Isala
🇳🇱
Zwolle, Netherlands
Maasstad Ziekenhuis
🇳🇱
Rotterdam, Netherlands
King's College London
🇬🇧
London, United Kingdom