ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 55 of 668 for:    diabetes AND Hypoglycemic | Recruiting, Not yet recruiting, Available Studies

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03003806
Recruitment Status : Recruiting
First Posted : December 28, 2016
Last Update Posted : June 21, 2018
Sponsor:
Collaborators:
DreaMed
The Leona M. and Harry B. Helmsley Charitable Trust
Information provided by (Responsible Party):
Rabin Medical Center

Brief 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 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:

  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.


Condition or disease Intervention/treatment Phase
Type1 Diabetes Mellitus Device: DreaMed Advisor Pro Other: Medical guided recommendation Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 2, 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: DreaMed Advisor Pro
Insulin pump settings (i.e, basal plan, correction factor, carbohydrate ratio and insulin activity time) will be adjusted using the DreaMed Advisor Pro
Device: DreaMed Advisor Pro
Insulin pump settings (i.e, basal plan, correction factor, carbohydrate ratio and insulin activity time) will be adjusted using the DreaMed Advisor Pro

Active Comparator: Control group-medical guided recommendations
Insulin pump settings (i.e, basal plan, correction factor, carbohydrate ratio and insulin activity time) will be adjusted by the medical team
Other: Medical guided recommendation
Insulin pump settings (i.e, basal plan, correction factor, carbohydrate ratio and insulin activity time) will be adjusted by the medical team




Primary Outcome Measures :
  1. Percentage of glucose readings within range of 70-180 mg/dl (3.9 to 10 mmol/l). [ Time Frame: Final visit (week 31) ]
  2. Percentage of glucose readings below 54 mg/dl (3.3 mmol/l) [ Time Frame: Final visit (week 31) ]

Secondary Outcome Measures :
  1. HbA1c [ Time Frame: Final visit (week 31) ]
  2. Percentage of glucose readings below 70 mg/dl (3.9 mmol/L) [ Time Frame: Final visit (week 31) ]
  3. Percentage of readings below 50 mg/dl (2.8 mmol/L) [ Time Frame: Final visit (week 31) ]
  4. Percentage of readings above 180 mg/dl (10.0 mmol/L) [ Time Frame: Final visit (week 31) ]
  5. Percentage of readings above 240 mg/dl (13.3 mmol/L) [ Time Frame: Final visit (week 31) ]
  6. Area above the curve of glucose glucose level of 180 mg/dl [ Time Frame: Final visit (week 31) ]
  7. Area under the curve of glucose level of 70 mg/dl [ Time Frame: Final visit (week 31) ]
  8. Mean sensor blood glucose [ Time Frame: Final visit (week 31) ]
  9. Glucose variability measured by Standard Deviation [ Time Frame: Final visit (week 31) ]
  10. Number of recommendations for changes in settings per patient [ Time Frame: Final visit (week 31) ]
  11. Number of recommendations for changes in settings per iteration [ Time Frame: Final visit (week 31) ]
  12. Number of physician override Advisor recommendations [ Time Frame: Final visit (week 31) ]
  13. Number of patients overrides of recommendation [ Time Frame: Final visit (week 31) ]
  14. Estimated time duration needed for the physician to give its recommendations [ Time Frame: Final visit (week 31) ]
  15. Device satisfaction questionaire [ Time Frame: Final visit (week 31) ]
  16. Diabetes treatment satisfaction questionnaire [ Time Frame: Final visit (week 31) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   10 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)
  • 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)

Exclusion Criteria:

  • 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". -
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03003806


Contacts
Contact: Moshe Phillip, Prof 972-3-9253282 mosheph@clalit.org.il

Locations
United States, Colorado
Barbara Davis Center for Childhood Diabetes Recruiting
Aurora, Colorado, United States, 80045-6511
Contact: Robert Slover, Prof         
Principal Investigator: Robert Slover, Prof         
United States, Connecticut
Yale University School of Medicine Recruiting
New Haven, Connecticut, United States, 06520-8064
Contact: Stuart Weinzimer, Prof         
Principal Investigator: Stuart Weinzimer, Prof         
United States, Florida
University of Florida College of Medicine Recruiting
Gainesville, Florida, United States, 32610
Contact: Desmond Schatz, Prof         
Principal Investigator: Desmond Schatz, Prof         
United States, Massachusetts
Joslin Diabetes Center, One Joslin Place Recruiting
Boston, Massachusetts, United States, 02215
Contact: Lori Laffel, Prof         
Principal Investigator: Lori Laffel, Prof         
Germany
Diabetes -Zentrum fuer kinder und jugendliche Not yet recruiting
Hannover, Germany
Contact: Thomas Danne, MD    +49 511 8115 3330      
Principal Investigator: Thomas Danne, MD         
Israel
Schnider children's medical center Recruiting
Petach-Tikva, Israel, 49202
Contact: Moshe Phillip, Professor    972-3-9253778    mosheph@clalit.org.il   
Principal Investigator: Moshe Phillip, Prof         
Sub-Investigator: Revital Nimri, Dr.         
Sub-Investigator: Liat De Vries, Dr.         
Sub-Investigator: Liora Lazar, Dr.         
Sub-Investigator: Tal Oron, Dr.         
Sub-Investigator: Ariel Tenennbaum, Dr.         
Sub-Investigator: Shlomit Shalitin, Dr.         
Sub-Investigator: Alon Farfel, Dr         
Sub-Investigator: Judit Nir, Dr         
Sub-Investigator: Naama Fish, Dr         
Sub-Investigator: Sari Karpel, Dr         
Slovenia
University Children's Hospital Active, not recruiting
Ljubljana, Slovenia
Sponsors and Collaborators
Rabin Medical Center
DreaMed
The Leona M. and Harry B. Helmsley Charitable Trust

Responsible Party: Rabin Medical Center
ClinicalTrials.gov Identifier: NCT03003806     History of Changes
Other Study ID Numbers: RMC072016ctil
First Posted: December 28, 2016    Key Record Dates
Last Update Posted: June 21, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Rabin Medical Center:
Insulin pump treatment
Type 1 diabetes
Pump setting advisor

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Hypoglycemic Agents
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin
Physiological Effects of Drugs