Status:
COMPLETED
Basal Insulin Glycemic ControL With DEglugec vs Aspart Via Pump
Lead Sponsor:
Mountain Diabetes and Endocrine Center
Collaborating Sponsors:
Novo Nordisk A/S
Conditions:
Type1 Diabetes Mellitus
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this investigator-initiated trial is to compare the effect of a daily injection of insulin degludec vs. basal insulin delivery via Continuous Subcutaneous Insulin Infusion (CSII), both ...
Detailed Description
The primary objective of this trial is to determine whether insulin degludec will provide an equally stable and consistent basal glycemic profile with lower glycemic variability as determined by Conti...
Eligibility Criteria
Inclusion
- Male and female patients \> 18 years of age with type 1 diabetes using CSII with any pump for \> 12 months.
- Females must be using adequate contraception, defined as oral contraceptive pill, barrier method of contraception, or surgical method (tubal ligation or hysterectomy).
- Good glycemic control (HbA1c \< 8.0%).
- Patients are experienced in carbohydrate counting, evidenced by pump downloads showing frequent meal boluses with realistic carbohydrate entries, few over-rides of the pump bolus calculator, few to no omitted boluses (at least 3 boluses per day), and post-meal glucose levels generally below 200 mg/dl indicating accurate carbohydrate assessment.
- Patients are regular (\>85% of time) users of the Dexcom G5 or G6 CGM.
- Pump download confirms correct use of insulin pump features, including appropriate use of bolus calculator with minimal overrides, entering carbohydrate content of meals, at least 3 boluses taken per day, appropriate use of correction boluses, and infusion set changes every 2 to 3 days.
- No serious comorbidities including: retinopathy requiring active intervention, eGFR \< 30, CV event within the previous 6 months, active malignancy with ongoing treatment, any condition requiring chronic use of systemic glucocorticoids, or any other condition which in the opinion of the investigator would interfere with the subject's ability to comply with the study protocol or acutely affect insulin requirements.
- Able to comply with study protocol.
- Ability to provide written informed consent prior to any study-related procedures.
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Exclusion
- Subjects with type 2 diabetes.
- Subjects with HbA1c \> 8.0%
- Subjects not using CSII and CGM (ie, on MDI)
- Subjects inexperienced in the use of CSII, or whose pump download shows poor utilization of bolus calculator features, ie fewer than 2 boluses per day, lack of correction boluses, frequent overrides of the recommended boluses, unrealistic carbohydrate entries (suggestive of under-bolusing), not changing infusion set at least every 3 days, or other evidence of poor insulin pump usage.
- Subjects inexperienced in or not regular users (\>85% of time) of Dexcom G5 or G6 CGM
- Subjects who are using a Medtronic pump with low blood glucose suspend who are unwilling to use the Dexcom CGM or to disengage the low blood glucose suspend feature of the pump.
- Use of any other CGM than Dexcom G5 or G6.
- Serious concomitant illness.
- Females unwilling to use adequate contraception, intending to become pregnant, or breastfeeding.
- Known or suspected allergy to study products, their excipients or related products.
- Previous participation in this trial. Note: subjects who screen fail because of A1c may rescreen once if, in the opinion of the investigator, the HbA1c was explainable (ie, recent steroid injection or illness, etc) and atypical for the subject.
- Hypoglycemic unawareness.
- Episode of severe hypoglycemia (requiring assistance for treatment) within the previous 90 days.
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Key Trial Info
Start Date :
April 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2020
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT04409587
Start Date
April 12 2018
End Date
November 1 2020
Last Update
February 24 2021
Active Locations (1)
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1
Mountain Diabetes and Endocrine Center
Asheville, North Carolina, United States, 28803