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Clinical Trial NCT04414579 (PLATEAU) for Type 1 Diabetes Mellitus is unknown status. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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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 Investigator-Initiated
Clinical Trial NCT04414579 (PLATEAU) is designed to study Treatment for Type 1 Diabetes Mellitus. It is a Phase 4 interventional study that is unknown status, having started on 27 March 2019, with plans to enroll 45 participants. Led by Mountain Diabetes and Endocrine Center, it is expected to complete by 1 March 2021. The latest data from ClinicalTrials.gov was last updated on 24 November 2020.
Brief Summary
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...Show More
Detailed Description
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...Show More
Official Title
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
Conditions
Type 1 Diabetes MellitusPublications
Scientific articles and research papers published about this clinical trial:Other Study IDs
- PLATEAU
- GPP2019
NCT ID Number
Start Date (Actual)
2019-03-27
Last Update Posted
2020-11-24
Completion Date (Estimated)
2021-03
Enrollment (Estimated)
45
Study Type
Interventional
PHASE
Phase 4
Status
Unknown status
Keywords
continuous glucose monitoring
continuous subcutaneous insulin infusion
hyperglycemia
correction bolus
continuous subcutaneous insulin infusion
hyperglycemia
correction bolus
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Crossover Assignment
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
No 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...Show More | N/A |
Active 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...Show More | 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...Show More |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 |
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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 CenterStudy Responsible Party
Wendy Lane MD, Principal Investigator, Wendy Lane, MD, Principal Investigator, Mountain Diabetes and Endocrine Center
Study Central Contact
Contact: Wendy S Lane, MD, 8286849588, [email protected]
Contact: Melinda L Buford, RN, BSN, 8286849588, [email protected]
1 Study Locations in 1 Countries
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, Sub-Investigator
Lynn L Baru, MD, Sub-Investigator
Michael D Skrzynski, ANP, Sub-Investigator
Recruiting