Observational, Data Collection Study for Subjects With Diabetes Using Insulin Injections

NCT04013919 | Unknown

• 1 other identifier: CR-0999
• Study Type: observational
• Target: 260
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Glucose levels

  Characterise the insulin-glucose dynamics for insulin users

  1 month

Study Arms (2)

Type 1 Diabetes

Drug: Multiple Daily Injections of Insulin

Type 2 Diabetes

Drug: Multiple Daily Injections of Insulin; Drug: Single insulin injections

Interventions

Multiple Daily Injections of Insulin DRUG

Basal/ Bolus insulin injections

Type 1 Diabetes; Type 2 Diabetes

Single insulin injections DRUG

Basal insulin injections only

Type 2 Diabetes

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• DreaMed Diabetes: lead

Study Sites (1)

Scheider MC

Petah Tikva, 4952805, Israel

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Yael Shtrit

CONTACT

0502428305; yael.shtrit@dreamed-diabetes.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2019
• First Posted: July 10, 2019
• Study Start: September 20, 2019
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: December 26, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)