Status:
UNKNOWN
Observational, Data Collection Study for Subjects With Diabetes Using Insulin Injections
Lead Sponsor:
DreaMed Diabetes
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
1+ years
Brief Summary
This is an observational, multicenter prospective study including up to 260 subjects with type 1 or type 2 diabetes who use insulin injections (either basal insulin only or multiple daily injections (...
Eligibility Criteria
Inclusion
- Documented T1D or T2D for at least 1 year prior to study enrolment
- T1D: Subjects aged 1 year or older
- T2D: Subjects aged 30 years or older
- A1c at inclusion ≤ 10%
- Subjects using basal-bolus MDI therapy or basal insulin only - basal insulin Lantus or Tregludec and any short acting insulin.
- T2D: Insulin pumps will also be accepted.
- T2D: BMI ≥ 25 kg/m2
- Subjects willing to follow study instructions:
- For SMBG users: measure capillary blood glucose at least 4 times a day and twice a week 7-point profile. Document blood glucose level, insulin delivery, meals and daily activities. Optional: wear blinded CGM.
- For CGM users: Document insulin delivery, meals and daily activities. Optional:
- Measure capillary blood glucose in addition.
- Adult subjects or parents of pediatric subjects willing and able to sign a written informed consent form.
Exclusion
- An episode of diabetic keto-acidosis within the month prior to study entry and/or severe hypoglycemia resulting in seizure or loss of consciousness in the month prior to enrolment.
- Concomitant diseases/ treatment that influence metabolic control (except diabetes treatment for T2) or any significant diseases /conditions including psychiatric disorders and substance abuse that in the opinion of the investigator is likely to affect the subject's ability to complete the study or compromise subject's safety
- T2D: eGFR \< 60
- Participation in any other interventional study
- Female subject who is pregnant or planning to become pregnant within the planned study duration
- T1D: Subject is in the "honeymoon" phase - i.e. less than 0.5 insulin units/kg per day.
- Drug or alcohol abuse.
Key Trial Info
Start Date :
September 20 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2020
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT04013919
Start Date
September 20 2019
End Date
April 1 2020
Last Update
December 26 2019
Active Locations (1)
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1
Scheider MC
Petah Tikva, Israel, 4952805