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De klinische studie NCT04414579 (PLATEAU) voor Type 1 diabetes mellitus is onbekend. Bekijk de kaartweergave van de Klinische Studies Radar en de AI-ontdekkingstools voor alle details. Of stel hier een vraag. | ||
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Kaartweergave
The Efficacy and Safety of Faster Insulin Aspart (Fiasp®) Compared to Conventional Insulin Aspart (NovoLog®) as Correction Bolus (PLATEAU) Fase 4 45 Onderzoeker-geïnitieerd
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De klinische studie NCT04414579 (PLATEAU) onderzoekt behandeling bij Type 1 diabetes mellitus. Deze Fase 4 interventioneel-studie heeft de status onbekend. Het doel is om 45 deelnemers te includeren vanaf 27 maart 2019. De studie wordt geleid door Mountain Diabetes and Endocrine Center en de voltooiing is gepland op 1 maart 2021. Laatste update op ClinicalTrials.gov: 24 november 2020.
Beknopte samenvatting
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...Toon meer
Uitgebreide beschrijving
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...Toon meer
Officiële 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
Aandoeningen
Type 1 diabetes mellitusPublicaties
Wetenschappelijke artikelen en onderzoekspapers gepubliceerd over deze klinische studie:Andere studie-ID's
- PLATEAU
- GPP2019
NCT-ID
Startdatum (Werkelijk)
2019-03-27
Laatste update geplaatst
2020-11-24
Verwachte einddatum
2021-03
Inschrijving (Geschat)
45
Studietype
Interventioneel
FASE
Fase 4
Status
Onbekend
Trefwoorden
continuous glucose monitoring
continuous subcutaneous insulin infusion
hyperglycemia
correction bolus
continuous subcutaneous insulin infusion
hyperglycemia
correction bolus
Primaire doel
Behandeling
Toewijzing
Gerandomiseerd
Interventiemodel
Cross-over
Blindering
Geen (Open-label)
Armen / Interventies
| Deelnemersgroep/Studiearm | Interventie/Behandeling |
|---|---|
Geen interventieNo 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...Toon meer | N.v.t. |
Actieve comparatorFaster 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...Toon meer | 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...Toon meer |
Primaire uitkomst
Secundaire uitkomst
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
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 |
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
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 |
Geschiktheidscriteria
Leeftijd van deelnemers
Volwassene, Oudere volwassene
Minimumleeftijd
18 Years
Geslachten die in aanmerking komen voor de studie
Allen
- 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 CenterVerantwoordelijke instantie
Wendy Lane MD, Hoofdonderzoeker, Wendy Lane, MD, Principal Investigator, Mountain Diabetes and Endocrine Center
Centraal Contactpersoon
Contact: Wendy S Lane, MD, 8286849588, [email protected]
Contact: Melinda L Buford, RN, BSN, 8286849588, [email protected]
1 Studielocaties in 1 landen
North Carolina
Mountain Diabetes and Endocrine Center, Asheville, North Carolina, 28803, United States
Melinda L Buford, RN, BSN, Contact, 828-684-9588, [email protected]
Stephen L Weinrib, MD, Subonderzoeker
Lynn L Baru, MD, Subonderzoeker
Michael D Skrzynski, ANP, Subonderzoeker
Rekruterend