Study of MiniMed™ 640G Insulin Pump With SmartGuard™ in Prevention of Low Glucose Events in Adults With Type 1 Diabetes (SMILE)
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Besançon, Frankrike
- CHU de Besançon
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Grenoble, Frankrike
- Chu Grenoble
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Marseille, Frankrike
- APHM - La Conception
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Montpellier, Frankrike
- CHU Montpellier - Hôpital Lapeyronie
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-
-
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Bergamo, Italia
- Ospedale Papa Giovanni Xxiii
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Milan, Italia
- Ospedale S. Raffaele
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Olbia, Italia
- Ospedale S. Gionanni di Dio
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-
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Gouda, Nederland
- Groene Hart Ziekenhuis
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Rotterdam, Nederland
- Maasstad ziekenhuis
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Utrecht, Nederland
- UMC Utrecht
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Zwolle, Nederland
- Isala
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London, Storbritannia, SE5 9NU
- King's College London
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Manchester, Storbritannia
- Manchester Diabetes Center
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N. Yorkshire
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Harrogate, N. Yorkshire, Storbritannia, HG2 7SX
- Harrogate District Hospital
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Treatment
MiniMed™640G and Suspend before Low feature of SmartGuard™ turned on.
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All enrolled subjects will start a run in phase, receive training and start pump therapy with the MiniMed™640G insulin pump and usage of blinded Continuous Glucose Monitoring. Eligible subjects that meet the randomization criteria assessed after the running phase will be randomized into the treatment or control arm. Treatment Arm: training and start of Sensor Augmented Pump therapy with Suspend before Low feature of SmartGuard turned ON. Control Arm: continuation of pump therapy alone with blinded continuous glucose monitoring for a total of 6 weeks during the treatment phase.
Andre navn:
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Aktiv komparator: Control
MiniMed™640G alone
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Control Arm: continuation of pump therapy alone with blinded continuous glucose monitoring for a total of 6 weeks.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Mean Number of Sensor Glucose Hypoglycaemic Events Below or Equal to 55 mg/dL Per Patient/Week.
Tidsramme: 6 months
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6 months
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Mean Time Spent of Sensor Glucose Values Below or Equal 55 mg/dL.
Tidsramme: 6 months
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6 months
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Mean Time Spent of Sensor Glucose Values Within Range and Including 70-180 mg/dL.
Tidsramme: 6 months
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6 months
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Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Habteab A, Castaneda J, de Valk H, Choudhary P, Bosi E, Lablanche S, de Portu S, Da Silva J, Vorrink-de Groot L, Shin J, Cohen O. Predicting Factors Associated with Hypoglycemia Reduction with Automated Predictive Insulin Suspension in Patients at High Risk of Severe Hypoglycemia: An Analysis from the SMILE Randomized Trial. Diabetes Technol Ther. 2020 Sep;22(9):681-685. doi: 10.1089/dia.2019.0495.
- Bosi E, Choudhary P, de Valk HW, Lablanche S, Castaneda J, de Portu S, Da Silva J, Re R, Vorrink-de Groot L, Shin J, Kaufman FR, Cohen O; SMILE Study Group. Efficacy and safety of suspend-before-low insulin pump technology in hypoglycaemia-prone adults with type 1 diabetes (SMILE): an open-label randomised controlled trial. Lancet Diabetes Endocrinol. 2019 Jun;7(6):462-472. doi: 10.1016/S2213-8587(19)30150-0. Epub 2019 Apr 29.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CEP311
Plan for individuelle deltakerdata (IPD)
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