- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04013919
Observational, Data Collection Study for Subjects With Diabetes Using Insulin Injections
Observational, Data Collection Study for Subjects With Diabetes Using Daily Insulin Injections and Monitoring Glucose by Continuous Glucose Monitoring or Self-Monitoring Blood Glucose
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Yael Shtrit
- Phone Number: 0502428305
- Email: yael.shtrit@dreamed-diabetes.com
Study Locations
-
-
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Petach Tikva, Israel, 4952805
- Recruiting
- Scheider MC
-
Contact:
- Orna Harmon
- Phone Number: 972-3-9253618
- Email: Ornah2@clalit.org.il
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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 Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Type 2 Diabetes
|
Basal/ Bolus insulin injections
Basal insulin injections only
|
Type 1 Diabetes
|
Basal/ Bolus insulin injections
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Glucose levels
Time Frame: 1 month
|
Characterise the insulin-glucose dynamics for insulin users
|
1 month
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR-0999
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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