رادار التجارب AI | ||
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حالة التجربة السريرية NCT03668808 (SafrTravlT1D) لـ داء السكري النوع 1 هي مكتمل. اطلعوا على جميع التفاصيل في عرض البطاقة الخاص برادار التجارب السريرية وأدوات اكتشاف الذكاء الاصطناعي. أو يمكنكم طرح أي سؤال هنا. | ||
Comparison of Insulin Degludec With Insulin Glargine U100 for Adults With Type 1 Diabetes Crossing Multiple Time Zones. (SafrTravlT1D) المرحلة الرابعة ٢٥
Comparison of Insulin Degludec With Insulin Glargine U100 for Adults With Type 1 Diabetes Travelling Across Multiple Time Zones. A Pilot Study.
- SafrTravlT1D
- ISS-001227
- U1111-1210-7350 (معرف السجل) (Universal Trial Number - World Health Organization (WHO))
Insulin Glargine
Air Travel
Continuous Glucose Monitor
| مجموعة المشاركين/الذراع | التدخل/العلاج |
|---|---|
تجريبيةInsulin Degludec Subjects with type 1 diabetes and on multiple daily injections will use basal insulin Degludec and the TRESIBA® FLEXTOUCH® pens during a long-haul flight and randomized to this arm first or second. | Insulin Degludec Subjects will use Insulin Degludec (Tresiba) with TRESIBA® FLEXTOUCH® pens as their basal insulin during a 9-10 hour flight, at each destination, and then during a return flight. TRESIBA® FLEXTOUCH® Subjects will use Tresiba FlexTouch pens when using Tresiba as their basal insulin during a 9-10 hour flight, at each destination, and then during a return flight. |
مقارن نشطInsulin Glargine U100 Subjects with type 1 diabetes and on multiple daily injections will use basal insulin Glargine U100 and the LANTUS® SOLOSTAR® INSULIN PEN during a long-haul flight and randomized to this arm first or second. | Insulin Glargine Subjects will use Insulin Glargine (Lantus) with LANTUS® SOLOSTAR® INSULIN PEN as their basal insulin during a 9-10 hour flight, at each destination, and then during a return flight. LANTUS® SOLOSTAR® INSULIN PEN Subjects will use Lantus SoloStar insulin pens when using Lantus as their basal insulin during a 9-10 hour flight, at each destination, and then during a return flight. |
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
Continuous Glucose Monitoring - Time in Range (70-140 mg/dl) | Time in range (70-140 mg/dl) \[percentage of glucose readings or hours per day\] by continuous glucose monitoring (CGM) during the initial 24 hours local time (starting within 2 hours after arriving) in Newark, NJ after flying 9-10 hours West to East (from Honolulu, HI) and after the return journey from Newark to Honolulu (flying East to West). | During the initial 24 hours local time and starting within 2 hours after arrival |
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
Continuous Glucose Monitoring - Time in Range (70-180 mg/dl) | Time in range (70-180 mg/dl) \[percentage of glucose readings or hours per day\] by continuous glucose monitoring (CGM) during the first 24 hours after arriving in HNL and EWR (starting within 2 hours after arrival). | During the initial 24 hours local time and starting within 2 hours after arrival |
Mean ± SD CGM Glucose (mg/dl) | Mean ± standard deviation of CGM glucose (mg/dl) by CGM during the flight and during the 72 hours at the destination | In flight period of time and for 72 hours at each destination |
CGM % Time <70 mg/dl | % time \<70 mg/dl by CGM | In flight period of time and for 72 hours at each destination |
CGM % Time 70-180 mg/dl | % time 70-180 mg/dl by CGM | In flight period of time and for 72 hours at each destination |
CGM % Time >180 mg/dl | % time \>180 mg/dl by CGM | In flight period of time and for 72 hours at each destination |
CGM - Coefficient of Variation (CV) | Coefficient of variation of CGM values - glycemic variability (CV, %) | In flight period of time and for 72 hours at each destination |
CGM Fasting Blood Glucose (FBG) | Fasting Blood Glucose (FBG) was determined using CGM at each destination on the morning after arrival. | At 0600 local time on the morning after arrival at each destination |
Liverpool Jet-Lag Questionnaire | This is a Questionnaire about jet-lag and fatigue administered at the destinations after arrival. Jet Lag is rated on a 0-10 scale (0 - insignificant jet lag to 10 - very bad jet lag). Fatigue is rated on a scale of -5 to +5 (more fatigue to less fatigue). | After 24 and 48 hours at the destination after arrival |
Sleep Quantity Measured by ActiGraph | Measurement of sleep duration (TST - Total sleep time in minutes) | During 24 hours at each destination |
Sleep Efficiency Measured by ActiGraph | Measurement of sleep efficiency (SE% - total sleep time in minutes divided by time in bed in minutes) | During 24 hours at each destination |
Males or females ≥18 and ≤65 years of age.
Type 1 diabetes mellitus (diagnosed clinically and treated with multiple daily injections of insulin) for ≥12 months.
HbA1c <10% within 30 days of being enrolled in the study
Current treatment with any basal insulin analogue as the once daily basal insulin given in the evening (22) and no fewer than three injections with rapid acting bolus insulin (e.g. insulin aspart, insulin lispro, or insulin glulisine) as mealtime bolus insulin therapy.
No contraindication to long-haul travel.
No recurrent severe hypoglycemia (more than 1 severe hypoglycemic event requiring hospitalization during the last 12 months), or hypoglycemia unawareness as judged by a score of >4 on the Gold score (23), or hospitalization for diabetic ketoacidosis during the previous 6 months.
Willing and able to use a continuous glucose monitoring device (e.g. Dexcom G4).
Ability to self-manage insulin therapy (verbal confirmation at screening visit) of a changed bolus insulin dose the preceding 2 months prior to screening.
Ability and willingness to adhere to the protocol, including performance of self-monitored blood glucose (SMBG) readings and self-adjustment of insulin doses according to protocol.
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Current use of an insulin pump.
Use within the last 3 months prior to enrollment visit 1 of any glucose-lowering drug other than insulin.
Initiation or significant change of any systemic treatment which, in the investigator's opinion, could interfere with glucose metabolism, such as systemic corticosteroids, beta-blockers or monoamine oxidase inhibitors (inhaled corticosteroids allowed).
Proliferative retinopathy or maculopathy requiring treatment, according to the investigator.
Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures.
Any clinically significant disease or disorder, which in the investigator's opinion could interfere with the results of the trial.
Mental incapacity, psychiatric disorder, unwillingness or language barriers precluding adequate understanding or cooperation, including subjects not able to read or write, and known or suspected abuse of alcohol, narcotics, or illicit drugs.
Known or suspected allergy to any of the trial products or related products.
Receipt of any investigational drug or participation in other trials within 1 month prior to Visit 1.
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Sansum Diabetes Research Instituteنوفو نورديسك131 دراسات نشطة للاستكشافCalifornia
Hawaii