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: Unknown
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Drug: Multiple Daily Injections of Insulin; Drug: Single insulin injections

• Study Type: Observational
• Enrollment (Anticipated): 260

Contacts and Locations

Study Locations

• Israel
  • Petach Tikva, Israel, 4952805
    • Recruiting
    • Scheider MC
    • Contact: Orna Harmon; Phone Number: 972-3-9253618; Email: Ornah2@clalit.org.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Type 2 Diabetes	Drug: Multiple Daily Injections of Insulin; Basal/ Bolus insulin injections; Drug: Single insulin injections; Basal insulin injections only
Type 1 Diabetes	Drug: Multiple Daily Injections of Insulin; Basal/ Bolus insulin injections

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glucose levels	Characterise the insulin-glucose dynamics for insulin users	1 month

Collaborators and Investigators

• Sponsor: DreaMed Diabetes

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2019
• Primary Completion (Anticipated): April 1, 2020
• Study Completion (Anticipated): April 1, 2020

Study Registration Dates

• First Submitted: July 8, 2019
• First Submitted That Met QC Criteria: July 8, 2019
• First Posted (Actual): July 10, 2019

Study Record Updates

• Last Update Posted (Actual): December 26, 2019
• Last Update Submitted That Met QC Criteria: December 22, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc
• Other Study ID Numbers: CR-0999

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No