An interventional study of DreaMed Endo Digital in Type 1 Diabetes, sponsored by Rabin Medical Center. Terminated at 1 site in Israel. Open to participants aged 6 Years to 30 Years. Per ClinicalTrials.gov, last updated 2024-04-12.
Sponsored by Rabin Medical Center · Not applicable, Interventional, and Treatment
The DreaMed Endo.Digital is indicated for use by healthcare professionals treating individuals with Type 1 Diabetes (T1D) who use insulin pump or multiple daily injections (MDI) as their insulin delivery therapy and monitor their glucose levels by using Continuous Glucose Monitoring (CGM) or Flash Glucose monitoring (FGM), or SMBG above the age of 6 years old and below 30 years.
DreaMed Endo.DigitalTM is indicated for use by healthcare professionals when analyzing CGM/SMBG and pump or MDI data to generate recommendations for optimizing a patient's insulin pump settings for basal rate, carbohydrate ratio (CR), and correction factor (CF); or MDI settings for basal rate, carbohydrate ratio (CR), and correction factor (CF) or Sliding Scale without considering the full clinical status of a particular patient. DreaMed Endo.DigitalTM does not replace clinical judgement.
The proposed study is an open label, interventional study that will include up to 500 participants with type 1 diabetes using insulin pumps or MDI therapy and monitoring glucose levels by continuous glucose monitoring including flash glucose monitoring or SMBG.
The proposed study will be 12 months, therefore will include 5 routine clinic visits.
At each visit, participants who use pump therapy will download their pump and glucose data (V1-V5) as they use to do at clinic visit. Participants who use MDI therapy will use the Endo.Digital App for insulin and glucose documentation and will upload data from their CGM/FGM or glucometer as they use to do at clinic visit.
In addition, participants will be offered to download data also at home in between study visits, every 3-6 weeks as they feel needed (Phone visits). Each time, optimization of pump settings or MDI will be done according to the downloaded data using the Endo.DigitalTM system. The device recommendations for insulin dosing adjustments and diabetes management tips will be reviewed by the treating physician. Each new treatment settings will be approved or edit by the study physician prior to implementation by the participant. At study completion, glycemic control will be evaluated by measured HbA1c and the data obtained from the participant devices and CGM/glucometer metrics, or Endo.Digital App data for MDI users.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 1 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Rabin Medical Center is the lead sponsor of 385 studies on the registry; 30 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Subjects using Insulin pump therapy for at least 3 months OR using basal-bolus MDI therapy either carbohydrate counting or using sliding scale for meal bolus:
Subjects willing to follow study instructions:
Exclusion Criteria:
Relevant severe organ disorders (diabetic nephropathy, diabetic retinopathy, diabetic foot syndrome) or any secondary disease or complication of diabetes mellitus, such as:
At each visit, participants who use pump therapy will download their pump and glucose data (V1-V5) as they use to do at clinic visit. Participants who use MDI therapy will use the Endo.Digital App for insulin and glucose documentation and will upload data from their CGM/FGM or glucometer as they use to do at clinic visit. In addition, participants will be offered to download data also at home in between study visits, every 3-6 weeks as they feel needed (Phone visits: P1-up to P8). Each time, optimization of pump settings or MDI will be done according to the downloaded data using the Endo.DigitalTM system. The device recommendations for insulin dosing adjustments and diabetes management tips will be reviewed by the treating physician. Each new treatment settings will be approved or edit by the study physician prior to implementation by the participant.
Device: DreaMed Endo Digital
The DreaMed Endo.Digital 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 insulin dose adjustments and behavioral tips for optimization of glucose control. The algorithm is designed as an advisory tool for health care professionals.
HbA1c
Time frame: 12 month
Percentage of sensor readings below 54 mg/dl
Time frame: 12 month
Percentage of sensor readings above 250 mg/dl
Time frame: 12 month
Percentage of sensor readings 54-70 mg/dl
Time frame: 12 month
Percentage of sensor readings 180-250mg/dl
Time frame: 12 month
Mean sensor glucose
Time frame: 12 month
Glucose variability measured as standard deviation
Time frame: 12 month
Total insulin dose
Time frame: 12 month
Total basal insulin dose
Time frame: 12 month
Total bolus insulin dose
Time frame: 12 month
Amount of carbohydrates consumed per day
Time frame: 12 month
Number of recommendations for changes in the treatment plan per patient
Time frame: 12 month
Number of recommendations for changes in the treatment plan per iteration
Time frame: 12 month
Number of physician overrides of Endo Digital recommendations
Time frame: 12 month
Device satisfaction
Device satisfaction evaluate by Healthcare Professionals Post-Intervention Survey
Time frame: 12 month
Patient satisfaction from the Mobile App
Time frame: 12 month
Frequency of home phone visits
Time frame: 12 month
The time required to review insulin and glucose data, make and send recommendations
The time required to review insulin and glucose data, make and send recommendations will be measured by timer or evaluate by length of visit
Time frame: 12 month
This study is terminated, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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