Clinical trial NCT04013919: Observational, Data Collection Study for Subjects With Diabetes Using Insulin Injections
Official title: Observational, Data Collection Study for Subjects With Diabetes Using Daily Insulin Injections and Monitoring Glucose by Continuous Glucose Monitoring or Self-Monitoring Blood Glucose
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes Mellitus
Lead sponsor: DreaMed Diabetes
Sponsor class: INDUSTRY
First posted: 2019-07-10
Enrollment: 260
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Up to 260 subjects with diabetes mellitus will be recruited in the following distribution: up to 100 T1D and up to 160 T2D. All subjects will be using multiple daily injections of insulin or basal injections only and self-monitoring blood glucose or continuous glucose monitoring.

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 (MDI)) and CGM or SMBG to manage their diabetes. The study aims to generate the database needed for future development and verification of insulin-glucose modules of subjects with diabetes using insulin injections.

During the study, subjects will continue their regular diabetes management using their regular glucose monitoring method (either CGM or SMBG), insulin injections and oral medication (as applicable). Subjects will be requested to document glucose levels and insulin delivery during basal only or basal/bolus insulin treatment. In addition, subjects will have their daily activities recorded (meals, physical activity etc) using electronic log (implemented on the CGM/FGM receiver, Dedicated App, Neura App and/or other logbooks). Data will be captured during regular daily life using Insulin Connected pens and daily diary application software, for a period of 1 month.


Eligibility criteria: Inclusion Criteria:

1. Documented T1D or T2D for at least 1 year prior to study enrolment
2. T1D: Subjects aged 1 year or older
3. T2D: Subjects aged 30 years or older
4. A1c at inclusion ≤ 10%
5. 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.
6. T2D: BMI ≥ 25 kg/m2
7. Subjects willing to follow study instructions:

   1. 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.
   2. For CGM users: Document insulin delivery, meals and daily activities. Optional:

   Measure capillary blood glucose in addition.
8. Adult subjects or parents of pediatric subjects willing and able to sign a written informed consent form.

Exclusion Criteria:

1. 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.
2. 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
3. T2D: eGFR \< 60
4. Participation in any other interventional study
5. Female subject who is pregnant or planning to become pregnant within the planned study duration
6. T1D: Subject is in the "honeymoon" phase - i.e. less than 0.5 insulin units/kg per day.
7. Drug or alcohol abuse.

Primary outcomes:
measure: Glucose levels
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Petach Tikva
country: Israel
facility: Scheider MC
Study officials:
References: