Diabetes MellitusNCT04013919
Observational, Data Collection Study for Subjects With Diabetes Using Insulin Injections
An observational study of Diabetes Mellitus, run by DreaMed Diabetes at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Multiple Daily Injections of Insulin and Single insulin injections
- Type of treatment
- Injection or infusion
- How many people
- 260 participants
- Where
- 1 siteIsrael
- Study dates
- 20 Sep 2019to Apr 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Scheider MC
Petah Tikva, 4952805
Orna Harmon, 972-3-9253618, Ornah2@clalit.org.il
About this study
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
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
- Being tested
- Multiple Daily Injections of Insulin, Single insulin injections
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiple Daily Injections of InsulinDrug
Basal/ Bolus insulin injections
Single insulin injectionsDrug
Basal insulin injections only
| Study group | Role | What they receive |
|---|---|---|
| Type 1 Diabetes | Not described Receives: Drug: Multiple Daily Injections of Insulin | |
| Type 2 Diabetes | Not described Receives: Drug: Multiple Daily Injections of Insulin; Drug: Single insulin injections |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose levels
Characterise the insulin-glucose dynamics for insulin users
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2019
- Study start20 Sep 2019
- Primary completionApr 2020 (estimated)
- Study completionApr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DreaMed Diabetes
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04013919
- Sponsor's protocol ID
- CR-0999
- Status last verified
- Dec 2019
- First submitted
- 8 Jul 2019
- Last updated
- 26 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04013919
- Acronym / sponsor ID
- CR-0999
- Conditions
- Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- DreaMed DiabetesIndustry (pharma, biotech, devices)
- Study start
- 20 Sep 2019 (actual)
- Primary completion
- Apr 2020 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 10 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Type 1 Diabetes | – | Drug: Multiple Daily Injections of Insulin |
| Type 2 Diabetes | – | Drug: Multiple Daily Injections of Insulin, Drug: Single insulin injections |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multiple Daily Injections of InsulinBasal/ Bolus insulin injections | Drug | Type 1 Diabetes, Type 2 Diabetes |
| Single insulin injectionsBasal insulin injections only | Drug | Type 2 Diabetes |
Primary outcome
Glucose levels
Time frame: 1 month
Characterise the insulin-glucose dynamics for insulin users
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, run by DreaMed Diabetes at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yael Shtrit (0502428305, yael.shtrit@dreamed-diabetes.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucose levels (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2019.