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COMPLETEDNA

DreaMed Advisor Pro System in Subjects With Type 1 Diabetes Treated With MDI Therapy

Evaluation of the DreaMed Advisor Pro System in Subjects With Type 1 Diabetes Treated With Multiple Daily Injections of Insulin

NCT04043260•DreaMed Diabetes

View on ClinicalTrials.gov

Summary

A multi center, open label, prospective study that will include up to 100 subjects with Type 1 Diabetes treated with Multiple Daily Injections (MDI) of insulin according to a predefined sliding scale plan or carbohydrate ratio (CR) and correction factor (CF) plan, and Self-Monitoring of Blood Glucose (SMBG) or Continuous Glucose Monitoring (CGM). The study will include screening, a 3-4 weeks run-in period and a 6 weeks intervention period. Subjects will be asked to record their insulin delivery during basal/bolus insulin treatment (using dedicated apps and/or connected pens) and their daily activities (meals, physical activity etc.) using electronic log (implemented on Dedicated Apps), for a total period of 9-10 weeks.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Documented T1D for at least 1 year prior to study enrolment
•2. Subjects aged 18 - 65 years old
•3. A1c at inclusion ≤ 10%
•4. Subjects using basal-bolus MDI therapy:
•1. Basal insulin: Glargine, Degludec, or Determir
•2. Bolus insulin: regular insulin, rapid analogues or ultra-rapid analogues
•5. Subjects using CGM or SMBG that are compatible with data transmission to the study DMS.
•6. BMI \< 28 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 (optional). Document blood glucose level, insulin delivery, meals and daily activities. Wear blinded CGM.
+4 more criteria

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 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 patients' safety
•3. Relevant severe organ disorders (diabetic nephropathy, diabetic retinopathy, diabetic foot syndrome) or any secondary disease or complication of diabetes mellitus, such as:
•* Subject has unstable or rapidly progressive renal disease or is receiving dialysis
•* Subject has active proliferative retinopathy
•* Active gastroparesis
•4. Participation in any other interventional study
•5. Female subject who is pregnant or planning to become pregnant within the planned study duration
•6. Subject is in the "honeymoon" phase - i.e. less than 0.5 insulin units/kg per day.
•7. Drug or alcohol abuse.

Locations (1)

Schneider MC

Petah Tikva, Israel

Key Dates

Start Date

November 27, 2019

Primary Completion Date

February 28, 2021

Completion Date

April 30, 2021

Last Updated

August 17, 2021

Enrollment

ACTUAL participants

Conditions

Insulin-dependent Diabetes MellitusDiabetes Mellitus, Type 1

Interventions

Advisor Pro

DEVICE

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Diabetes Mellitus, Type 1Impaired Hypoglycemic Awareness+1 more

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 17, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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DreaMed Advisor Pro System in Subjects With Type 1 Diabetes Treated With MDI Therapy

Inclusion Criteria

Exclusion Criteria

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