The Advisor Pro Direct Study

Not Applicable

Withdrawn

• Conditions: Type 1 Diabetes Mellitus
• Interventions: Device: DreaMed Advisor Pro; Other: Medical guided recommendation

• Registration Number: NCT03774069
• Lead Sponsor: 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. DreaMed Advisor Pro is a decision- support software intended for assisting healthcare professionals in the management of type 1 diabetes patients who use insulin pumps as their insulin delivery therapy and monitor their blood glucose levels using CGM (Continuous Glucose Monitoring) or CGM and self-management blood glucose meter.

The main objective of the proposed study is to test the safety, reliability, and efficacy of the DreaMed Advisor Pro algorithm when the recommendation is sent directly to the patient without a physician review.

Participants will be randomized in a 1:1 ratio to either the intervention group (DreaMed Advisor Pro) or control group (standard of care). Participants will download the CGM and pump data at no less frequent than every 4 weeks for both groups during the 3 months period of the study.

Each time new data is received, the following actions will be performed:

In the intervention group, a new algorithm recommendation for pump settings will be issued. The recommendation will be approved by a technical, non-physician to assure that glucose data are not fall within predefined safety criteria which require a physician approval before the recommendation will be sent to the patient, otherwise, recommendation will be sent directly to the patient.

In the control group, if no safety criteria is met, it is the responsibility of the patient to contact his/her physician to advise on change of treatment. In case a safety issue has occurred, the physician will contact the patient and change the pump settings.

Prior to initiating the interventional phase of the study, we will evaluate the experience of patients in self adjustments of insulin dosing in regular care management and to evaluate their acceptance for using an automated dosing recommendations software. The evaluation will be done by asking patients/caregivers to fill 15 questions survey. 100 patients are anticipated to participate in this phase of the study.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-12-11
• Study First Submitted QC: 2018-12-11
• Study First Posted: 2018-12-12
• Study Start: 2020-12-01
• Primary Completion: 2023-12-01
• Study Completion: 2023-12-01
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-25
• Last Update Posted: 2024-03-27

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Subject with type 1 diabetes (>1 yr diagnosis)
2. Age- 6-30 years old
3. HbA1c equals or above 7% and equals or below 10%
4. Insulin infusion pump CSII (Continuous Subcutaneous Inulin Infusion) therapy for at least 4 months and current treatment with one of the following pumps: Omnipod Insulet (Bedford, MA), Medtronic Minimed Veo insulinPump (MMT-754, MMT-554), Medtronic 640G or Animas.
5. BMI below 30 kg/m^2
6. Patients willing to follow study instructions (willing to measure capillary blood glucose as required by their glucose sensor for calibration and use the bolus- calculator feature of the pump)
7. Patients are required to have minimum computer skills and understanding of navigating the internet.
8. Patients are required to know basic English.
9. Patients willing to use glucose sensor for study duration.
10. Patients will have to have a smartphone (Apple or Android) or PC with email account.

Exclusion Criteria

1. An episode of diabetic ketoacidosis within the month prior to study entry

2. 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.

3. Current participation in any other interventional study.

4. Known or suspected allergy to trial products such as adhesives, tapes, needles.

5. Female subject who is pregnant or lactating or planning to become pregnant within the planned study duration

6. Severe hypoglycemia within six months prior to enrollment as defined by the ADA and Endocrine society as follows: Severe hypoglycaemia is an event requiring assistance of another person (due to change in mental status) to actively administer carbohydrates, glucagon, or take othe corrective actions.

7. Current use of the following medications: medications that are use 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.

8. Hypoglycemia unawareness

9. 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 proliferative retinopathy.
   • Active gastroparesis

10. Patient suffers from eating disorder. -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DreaMed Advisor Pro	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.
Control group- medical guided recommendation	Medical guided recommendation	Insulin pump settings (i.e, basal plan, correction factor, carbohydrate ration and insulin activity time) will be adjusted by the medical team

Primary Outcome Measures

Name	Time	Method
Percentage of glucose readings within range of 70-180 mg/dl (3.9 to 10mmol/L)	Final visit (week 12)
Percentage of readings below 54 mg/dl (3.3 mmol/l)	Final visit (week 12)

Secondary Outcome Measures

Name	Time	Method
Area under the curve of glucose level of 70 mg/dl	Final visit (week 12)
Diabetes treatment satisfaction questionnaire	Final visit (week 12)	The questionnaire contains 12-14 items (12 for the teens version and 14 for the parents version) the subscale for each items is from 0 to 6, and for most items the the higher the score, the greater the satisfaction with the treatment.Subscales are summed. More specific instruction for analysis are detailed in Diabetologia 52:(suppl 1) S397, Abstruct 1013 and in a document named "Summary of recommended scoring" by Prof. Bradley, University of London
Percentage of readings above 180 mg/dl (10.0mmol/L)	Final visit (week 12)
Number of recommendations sent to patient in the last 6 months prior to baseline and during intervention period	Final visit (week 12)
percentage of readings above 250 mg/dl (13.9 mmol/L)	Final visit (week 12)
Mean sensor blood glucose	Final visit (week 12)
Number of recommendations for changes in settings per patient	Final visit (week 12)
Number of recommendations for changes in settings per iteration	Final visit (week 12)
HbA1c	Final visit (week 12)
Percentage of readings below 60 mg/dl (3.35mmol/L)	Final visit (week 12)
Area under the curve of glucose level below 70 mg/dl	Final visit (week 12)
Glucose variability measured by standard deviation	Final visit (week 12)
Number of physician override Advisor recommendation	Final visit (week 12)
Percentage of glucose readings below 70 mg/dl (3.9 mmol/L)	Final visit (week 12)
Area above the curve of glucose level of 180 mg/dl	Final visit (week 12)
Area above the curve of glucose level above180 mg/dl	Final visit (week 12)

Trial Locations

Locations (1)

Schnider Children's medical center; 🇮🇱 Petach Tikva, Israel