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Type1 Diabetes MellitusAdvice4UNCT03003806

Evaluation of the Dreamed Advisor Pro for Automated Insulin Pump Setting Adjustments in Children and Adolescents With Type 1 Diabetes- The Advice4U Pro Study

A study testing DreaMed Advisor Pro and Medical guided recommendation in people with Type1 Diabetes Mellitus, run by Rabin Medical Center at 7 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The DreaMed Advisor Pro is a software which automatically analyses treatment information, learns patient's needs and accordingly suggests adjustments in insulin dosing. The DreaMed Advisor Pro uses information gathered from glucose monitoring (sensor readings or capillary blood glucose measurements), insulin dosing… Read more about this study

Who is it for?
Ages 10 to 21 years
Conditions the study is for
Type1 Diabetes Mellitus
What is being tested?
DreaMed Advisor Pro and Medical guided recommendation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
122 participants
Where
7 sitesin 4 countries
Study dates
2 Oct 2017to 10 Nov 2019
Phase
Interventional
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 10 to 21 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Subject with Type 1 diabetes (>1yr since diagnosis)
  • Age ≥ 10 years up to 21 years
  • HbA1c at inclusion ≥ 7.0% and ≤ 10%
  • Insulin infusion pump therapy: "OmniPod®" Insulin pump (insulet Corp., Bedford, "MA", USA) or any Medtronic pump that is comparable with Glooko app for at least 4 months
  • BMI Standard Deviation Score (SDS) - below the 97th percentile for age
  • Patients willing to follow study instructions (at least 2 capillary blood glucose readings/day, use the bolus-calculator feature of the pump)
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  • Patient/ parents are required to have minimum computer skills and understanding of navigating the internet
  • Patients willing to use dexcom sensor for the study duration
  • Patients/ parents will have to have a smart phone (Apple, Android, Windows)

Who cannot join

  • An episode of diabetic ketoacidosis within the month prior to study entry
  • Concomitant diseases/ treatment that influence metabolic control
  • 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 patient's safety,
  • Participation in any other interventional study
  • Known or suspected allergy to trial products such as adhesives, tapes, needles. An allergy to contrast medium, use of other active medical devices (such as pacemaker, ICD) and planned imaging examinations (such as MRI).
  • Female subject who is pregnant or lactating planning to become pregnant within the planned study duration -Severe hypoglycemia six month prior to enrollment as defined by the American Diabetes Association (ADA) and Endocrine Society as follows: "Severe hypoglycemia is an event requiring assistance of another person to actively administer carbohydrates, glucagon, or take other corrective actions". -
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  • Current use of the following medications: medications that are used to lower blood glucose such as Pramlintide, Metformin and GLP-1 analogs. Beta blockers, glucocorticoids and other medications, which in the judgment of the investigator would be a contraindication to participation in the study (Anticoagulant therapy e.g. Plavix, LMW heparin, Coumadin, Immunosuppressant therapy)
  • Relevant severe organ disorders (diabetic nephropathy, diabetic retinopathy, diabetic foot syndrome) or any secondary disease or complication of diabetes mellitus
  • Subject has unstable or rapidly progressive renal disease or is receiving dialysis
  • Subject has active proliferating retinopathy
  • Active gastroparesis
  • Patient suffers from an eating disorder

Trial locations and contacts

7 sites in 4 countries.

7 sites in 4 countries

United States4 sites

  • Barbara Davis Center for Childhood Diabetes

    Aurora, Colorado, 80045-6511

  • Joslin Diabetes Center, One Joslin Place

    Boston, Massachusetts, 02215

  • University of Florida College of Medicine

    Gainesville, Florida, 32610

  • Yale University School of Medicine

    New Haven, Connecticut, 06520-8064

Other trials in United States

Germany1 site

  • Diabetes -Zentrum fuer kinder und jugendliche

    Hanover

Other trials in Germany

Israel1 site

  • Schnider children's medical center

    Petah Tikva, 49202

Other trials in Israel

Slovenia1 site

  • University Children's Hospital

    Ljubljana

Other trials in Slovenia

About this study

Official title: Evaluation of the Dreamed Advisor Pro for Automated Insulin Pump Setting Adjustments in Children and Adolescents With Type 1 Diabetes- Open Label, Parallel , Randomized, Controlled Multicenter Study-The Advice4U Pro Study

The DreaMed Advisor Pro is a software which automatically analyses treatment information, learns patient's needs and accordingly suggests adjustments in insulin dosing. The DreaMed Advisor Pro uses information gathered from glucose monitoring (sensor readings or capillary blood glucose measurements), insulin dosing and meal data during daily routine home care. Following a 5-minute data collection and analysis, the algorithm learns and suggests pump-setting changes for optimization of glucose control

The algorithm is designed as an advisory tool and has three main components:

Read more
  1. A statistical analysis of the insulin pump and sensor data: insulin delivery, bolus-calculator rate of use, sensor glucose variables, hypoglycemic and hyperglycemia patterns.
  2. Practical recommendations, alert messages based on aforementioned data
  3. Recommendation for new insulin pump settings: including basal intervals and rate, different carbohydrate ratio according to time of day, correction factor and insulin sensitivity time.

The main goal of the DreaMed Advisor Pro is to improve diabetes management for subjects with Type 1 Diabetes (T1D) by using an innovative Advisor to determine insulin dosing for pump users.

The main objective of the proposed study is to evaluate the safety and efficacy of using the DreaMed Advisor Pro algorithm versus medical guided recommendation to determine insulin dosing for sub-optimal controlled subjects with type 1 diabetes using pump therapy.

Being tested
DreaMed Advisor Pro, Medical guided recommendation
Keywords
Insulin pump treatment, Type 1 diabetes, Pump setting advisor
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DreaMed Advisor ProDevice

    Insulin pump settings (i.e, basal plan, correction factor, carbohydrate ratio and insulin activity time) will be adjusted using the DreaMed Advisor Pro

  • Medical guided recommendationOther

    Insulin pump settings (i.e, basal plan, correction factor, carbohydrate ratio and insulin activity time) will be adjusted by the medical team

Study groups in NCT03003806
Study groupRoleWhat they receive
DreaMed Advisor ProExperimentalInsulin pump settings (i.e, basal plan, correction factor, carbohydrate ratio and insulin activity time) will be adjusted using the DreaMed Advisor Pro
Receives: Device: DreaMed Advisor Pro
Control group-medical guided recommendationsActive comparatorInsulin pump settings (i.e, basal plan, correction factor, carbohydrate ratio and insulin activity time) will be adjusted by the medical team
Receives: Other: Medical guided recommendation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of glucose readings within range of 70-180 mg/dl (3.9 to 10 mmol/l).

    Measured: Final visit (week 31)

  2. Percentage of glucose readings below 54 mg/dl (3.3 mmol/l)

    Measured: Final visit (week 31)

Secondary outcomes (16)

  1. HbA1c

    Measured: Final visit (week 31)

  2. Percentage of glucose readings below 70 mg/dl (3.9 mmol/L)

    Measured: Final visit (week 31)

  3. Percentage of readings below 50 mg/dl (2.8 mmol/L)

    Measured: Final visit (week 31)

  4. Percentage of readings above 180 mg/dl (10.0 mmol/L)

    Measured: Final visit (week 31)

  5. Percentage of readings above 240 mg/dl (13.3 mmol/L)

    Measured: Final visit (week 31)

  6. Area above the curve of glucose glucose level of 180 mg/dl

    Measured: Final visit (week 31)

  7. Area under the curve of glucose level of 70 mg/dl

    Measured: Final visit (week 31)

  8. Mean sensor blood glucose

    Measured: Final visit (week 31)

  9. Glucose variability measured by Standard Deviation

    Measured: Final visit (week 31)

  10. Number of recommendations for changes in settings per patient

    Measured: Final visit (week 31)

  11. Number of recommendations for changes in settings per iteration

    Measured: Final visit (week 31)

  12. Number of physician override Advisor recommendations

    Measured: Final visit (week 31)

  13. Number of patients overrides of recommendation

    Measured: Final visit (week 31)

  14. Estimated time duration needed for the physician to give its recommendations

    Measured: Final visit (week 31)

  15. Device satisfaction questionaire

    Measured: Final visit (week 31)

  16. Diabetes treatment satisfaction questionnaire

    Measured: Final visit (week 31)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Dec 2016 (estimated)
  2. Study start2 Oct 2017
  3. Primary completion10 Nov 2019
  4. Study completion10 Nov 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
122 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03003806
Sponsor's protocol ID
RMC072016ctil
Acronym
Advice4U
Status last verified
Jun 2019
First submitted
22 Dec 2016
Last updated
27 Dec 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Nimri R, Battelino T, Laffel LM, Slover RH, Schatz D, Weinzimer SA, Dovc K, Danne T, Phillip M; NextDREAM Consortium. Insulin dose optimization using an automated artificial intelligence-based decision support system in youths with type 1 diabetes. Nat Med. 2020 Sep;26(9):1380-1384. doi: 10.1038/s41591-020-1045-7. Epub 2020 Sep 9.

    PubMed 32908282

Questions about this trial

What is this clinical trial studying?

A study testing DreaMed Advisor Pro and Medical guided recommendation in people with Type1 Diabetes Mellitus, run by Rabin Medical Center at 7 sites in 4 countries.

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 9 inclusion and 12 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: finished, as of the sponsor's last update on 27 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 7 sites in United States, Germany, Israel, Slovenia. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of glucose readings within range of 70-180 mg/dl (3.9 to 10 mmol/l). (time frame: Final visit (week 31)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03003806, which also lists 1 linked publication.

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 27 Dec 2019.

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