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| Name | Class |
|---|---|
| DreaMed | INDUSTRY |
| The Leona M. and Harry B. Helmsley Charitable Trust | OTHER |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DreaMed Advisor Pro | Experimental | Insulin pump settings (i.e, basal plan, correction factor, carbohydrate ratio and insulin activity time) will be adjusted using the DreaMed Advisor Pro |
|
| Control group-medical guided recommendations | Active Comparator | Insulin pump settings (i.e, basal plan, correction factor, carbohydrate ratio and insulin activity time) will be adjusted by the medical team |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DreaMed Advisor Pro | Device | Insulin pump settings (i.e, basal plan, correction factor, carbohydrate ratio and insulin activity time) will be adjusted using the DreaMed Advisor Pro |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of glucose readings within range of 70-180 mg/dl (3.9 to 10 mmol/l). | Final visit (week 31) | |
| Percentage of glucose readings below 54 mg/dl (3.3 mmol/l) | Final visit (week 31) |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | Final visit (week 31) | |
| Percentage of glucose readings below 70 mg/dl (3.9 mmol/L) | Final visit (week 31) | |
| Percentage of readings below 50 mg/dl (2.8 mmol/L) |
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Inclusion Criteria:
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
Patient suffers from an eating disorder
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barbara Davis Center for Childhood Diabetes | Aurora | Colorado | 80045-6511 | United States | ||
| Yale University School of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32908282 | Derived | 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. |
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| Medical guided recommendation | Other | Insulin pump settings (i.e, basal plan, correction factor, carbohydrate ratio and insulin activity time) will be adjusted by the medical team |
|
| Final visit (week 31) |
| Percentage of readings above 180 mg/dl (10.0 mmol/L) | Final visit (week 31) |
| Percentage of readings above 240 mg/dl (13.3 mmol/L) | Final visit (week 31) |
| Area above the curve of glucose glucose level of 180 mg/dl | Final visit (week 31) |
| Area under the curve of glucose level of 70 mg/dl | Final visit (week 31) |
| Mean sensor blood glucose | Final visit (week 31) |
| Glucose variability measured by Standard Deviation | Final visit (week 31) |
| Number of recommendations for changes in settings per patient | Final visit (week 31) |
| Number of recommendations for changes in settings per iteration | Final visit (week 31) |
| Number of physician override Advisor recommendations | Final visit (week 31) |
| Number of patients overrides of recommendation | Final visit (week 31) |
| Estimated time duration needed for the physician to give its recommendations | Final visit (week 31) |
| Device satisfaction questionaire | Final visit (week 31) |
| Diabetes treatment satisfaction questionnaire | Final visit (week 31) |
| New Haven |
| Connecticut |
| 06520-8064 |
| United States |
| University of Florida College of Medicine | Gainesville | Florida | 32610 | United States |
| Joslin Diabetes Center, One Joslin Place | Boston | Massachusetts | 02215 | United States |
| Diabetes -Zentrum fuer kinder und jugendliche | Hanover | Germany |
| Schnider children's medical center | Petah Tikva | 49202 | Israel |
| University Children's Hospital | Ljubljana | Slovenia |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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