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The Efficacy and Safety of Faster Insulin Aspart (Fiasp®) Compared to Conventional Insulin Aspart (NovoLog®) as Correction Bolus (PLATEAU) Phase 4 45 Prüfer-initiiert

Unbekannter Status
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Die klinische Studie NCT04414579 (PLATEAU) untersucht Behandlung im Zusammenhang mit Typ-1-Diabetes mellitus. Diese interventionsstudie der Phase 4 hat den Status unbekannter status und startete am 27. März 2019. Es ist geplant, 45 Teilnehmer aufzunehmen. Durchgeführt von Mountain Diabetes and Endocrine Center wird der Abschluss für 1. März 2021 erwartet. Die Daten von ClinicalTrials.gov wurden zuletzt am 24. November 2020 aktualisiert.
Kurzbeschreibung
The purpose of this investigator-initiated trial is to compare the efficacy in terms of time to recovery from hyperglycemia as measured by time to arrest of hyperglycemic excursion ("glucose plateau point", primary endpoint) and return to premeal glucose target if feasible (secondary endpoint) between Fiasp and conventional insulin aspart when used as a correction bolus. These endpoints will be determined by CGM (Dex...Mehr anzeigen
Ausführliche Beschreibung
Patients with type 1 DM using CSII require bolus insulin for two purposes: first, to cover carbohydrate intake to control postprandial glucose, and second, to correct episodes of hyperglycemia. The latter function is referred to as a "correction dose" or "correction bolus". Insulin pumps have bolus calculators which calculate correction doses based on the patient's individualized BG target and insulin sensitivity fac...Mehr anzeigen
Offizieller Titel

The Efficacy and Safety of Faster Insulin Aspart (Fiasp®) Compared to Conventional Insulin Aspart (NovoLog®) as Correction Bolus in Patients With Type 1 Diabetes Using Continuous Subcutaneous Insulin Infusion (CSII) and Continuous Glucose Monitoring (CGM): a Cross-over Controlled Trial

Erkrankungen
Typ-1-Diabetes mellitus
Publikationen
Wissenschaftliche Artikel und Forschungspapiere zu dieser klinischen Studie:
Weitere Studien-IDs
  • PLATEAU
  • GPP2019
NCT-Nummer
NCT04414579
Studienbeginn (tatsächlich)
2019-03-27
Zuletzt aktualisiert
2020-11-24
Studienende (vorauss.)
2021-03
Geplante Rekrutierung
45
Studientyp
Interventionsstudie
PHASE
Phase 4
Status
Unbekannter Status
Stichwörter
continuous glucose monitoring
continuous subcutaneous insulin infusion
hyperglycemia
correction bolus
Primäres Ziel
Behandlung
Zuteilungsmethode
Randomisiert
Interventionsmodell
Crossover-Design
Verblindung
Keine (offene Studie)
Studienarme/Interventionen
Teilnehmergruppe/StudienarmIntervention/Behandlung
Keine InterventionNo Intervention: Conventional Insulin Aspart (NovoLog®)
In the aspart group, the subject will only take aspart through the their pump. This study population will have an established expertise in diabetes self-management with previous knowledge of insulin pump therapy and Dexcom Continuous Glucose Monitoring (CGM). Allowing the subjects to use their insulin pumps for bolus insulin delivery, as they are accustomed, will minimize the chances of skipping meal boluses and corr...Mehr anzeigen
Nicht zutreffend
Aktives VergleichspräparatFaster Insulin Aspart (Fiasp®)
In the Fiasp group, the subject will only take aspart through the their pump. This study population will have an established expertise in diabetes self-management with previous knowledge of insulin pump therapy and Dexcom Continuous Glucose Monitoring (CGM). Allowing the subjects to use their insulin pumps for bolus insulin delivery, as they are accustomed, will minimize the chances of skipping meal boluses and corre...Mehr anzeigen
Faster Insulin Aspart (Fiasp®)
Subjects will be randomized either to use Fiasp or conventional insulin aspart in CSII. CSII settings (basal, bolus, and correction factors) will be optimized using a meal challenge for a 2-week run in period followed by a 10-week period of CSII use with the assigned insulin. After a 12-week maintenance period, each group will cross over to the other insulin (conventional insulin aspart or Fiasp) by CSII for a second...Mehr anzeigen
Hauptergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
Time to stabilization of rising blood sugar by CGM after correction bolus
Time (in minutes) to stabilization of rising blood sugar (GPP) by CGM after correction bolus during the final 2 week maintenance period. Two categories of correction dose will be analyzed: 1) those following an isolated correction dose (taken independently of a meal dose), and 2) those taken as part of a combination bolus with a meal dose.
2 weeks
Nebenergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
Incidence of early hypoglycemia
Incidence of early hypoglycemia (Blood glucose \< 54 mg/dl within 1 and 2 hours) following correction bolus with each insulin (Key Safety Endpoint)
25 weeks
Change in Insulin Sensitivity Factor
Change in Insulin Sensitivity Factor, if any, required for hypoglycemia prevention using Fiasp as recorded by continuous subcutaneous insulin infusion device setting report
25 weeks
Change in Insulin On Board
Change in Insulin On Board, if any, required for prevention of late hyperglycemia using Fiasp as recorded by continuous subcutaneous insulin infusion device setting report
25 weeks
GlycoMark differences between arms
GlycoMark (1,5 anhydroglucitol, a marker of postprandial glucose excursion) during use of each insulin.
25 weeks
HbA1c differences between arms
HbA1c during use of each insulin
25 weeks
Percent time spent in target range, hyperglycemic range, and hypoglycemic range
Percent time spent in target range, hyperglycemic range and hypoglycemic range by Continuous Glucose Monitoring (CGM) on each insulin during the final 2 weeks of each treatment period. Target ranges include 70-180 mg/dL. Hyperglycemia ranges to be captured will include Category 1: 181-250 mg/dL and Category 2: above 250 mg/dL. Hypoglycemia ranges to be captured include Category 1: 69-54 mg/dL and Category 2: below 54 mg/dL.
4 weeks
Standard deviation differences between arms
Standard deviation of mean blood glucose as determined by CGM on each insulin
4 weeks
Treatment related impact measures between arms
Treatment related impact measures on each insulin using TRIM D questionnaire
6 weeks
Eignungskriterien

Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Alle
  • Male and female patients > 18 years of age
  • Type 1 DM of > 1 year duration
  • Use of any open loop insulin pump, Tandem T-Slim with Basal IQ, Insulet Omnipod Dash, or any other investigator-approved insulin pumps with Dexcom CGM G5, G6, or newer version for > 6 months
  • Good baseline glycemic control (HbA1c < 7.5%; low risk of hypoglycemia by CGM as defined by Dexcom Clarity report)
  • No episodes of severe hypoglycemia in the previous 3 months
  • Pump download shows regular meal bolusing, accurate carbohydrate counting ability, and willingness to use exercise markers in Dexcom
  • CGM download shows regular use (>85% of time) and regular calibration if using G5 sensor (G6 requires no calibration)
  • Females using adequate contraception

  • Use of CGM other than Dexcom G5 or G6 or a newer Dexcom CGM version
  • Suboptimal baseline glycemic control (HbA1c > 7.5%)
  • Pump or CGM download shows suboptimal use of devices (lack of meal boluses, frequent overrides of pump, excessive pump suspension, inadequate calibration or inconsistent usage of CGM)
  • Serious comorbidities including CVD with recent event, actively treated malignancy, renal dysfunction with eGFR < 45 ml/min, or any other condition which in the opinion of the investigator would preclude subject's ability to participate in trial
  • Females unwilling to use contraception, planning pregnancy or breastfeeding
  • Use of any other glucose-lowering agents than insulin
  • Hypersensitivity to insulin aspart or one of the excipients in faster insulin aspart
  • Known diabetic gastroparesis
Mountain Diabetes and Endocrine Center logoMountain Diabetes and Endocrine Center
Verantwortliche Partei
Wendy Lane MD, Hauptprüfer, Wendy Lane, MD, Principal Investigator, Mountain Diabetes and Endocrine Center
Zentrale Studienkontakte
Kontakt: Wendy S Lane, MD, 8286849588, [email protected]
Kontakt: Melinda L Buford, RN, BSN, 8286849588, [email protected]
1 Studienstandorte in 1 Ländern

North Carolina

Mountain Diabetes and Endocrine Center, Asheville, North Carolina, 28803, United States
Melinda L Buford, RN, BSN, Kontakt, 828-684-9588, [email protected]
Stephen L Weinrib, MD, Prüfarzt
Lynn L Baru, MD, Prüfarzt
Michael D Skrzynski, ANP, Prüfarzt
Offene Rekrutierung