Clinical trial NCT04653961: Evaluation of a Decision Support System for People With Diabetes Who Use Multiple Daily Insulin Injections- Feasibility and Proof of Concept Studies
Official title: Evaluation of a Decision Support System for People With Diabetes Who Use Multiple Daily Insulin Injections- Feasibility and Proof of Concept Studies
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type1diabetes
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
Collaborators: name: The Leona M. and Harry B. Helmsley Charitable Trust
name: DreaMed Diabetes
First posted: 2020-12-04
Enrollment: 48
Sex: ALL
Minimum age (years): 14
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study comprises of two segments: a feasibility segment and a Proof of Concept segment. The study is open label, prospective study that will include up to 72 subjects in segment 1 and up to 40 subjects in segment 2. Participants are people with Type 1 or type 2 Diabetes treated with Multiple Daily Injections ( MDI) and Self Monitoring of Blood Glucose (SMBG) or intermittent Continuous Glucose Monitoring (CGM).

The study will include screening, a 2-4-week run-in period and 10-12 weeks intervention period. Subjects will be asked to record their insulin delivery during basal/bolus insulin treatment (using dedicated apps ) and their daily activities (meals, physical activity etc.) using electronic log (implemented on Dedicated Apps), for a total period of 12-16 weeks.

The goal of this study is to evaluate the safety of a decision support system for adjustment of insulin treatment plan for people with diabetes using multiple daily injections and monitoring glucose by SMBG or intermittent CGM


Eligibility criteria: Inclusion Criteria:

* Documented Type 1 or Type 2 Diabetes for at least 1 year prior to study enrolment
* Aged ≥ 14 years
* HbA1c of 6.5 ≤ A1c ≤ 10%
* Using basal-bolus MDI therapy:

  1. Basal insulin: Glargine, Degludec, or detemir and up to sum of 72 units of basal insulin
  2. Bolus insulin: regular insulin, rapid analogues or ultra-rapid analogues
* Subjects willing to follow study instructions:

  1. For SMBG users (only for segment 1): measure capillary blood glucose at least 4 times a day . Document blood glucose level, insulin delivery, meals and daily activities. Wear CGM.
  2. For CGM users (FGM with a reader or real-time CGM): Use CGM according to manufacture instructions, document insulin delivery, meals and daily activities.
* Subjects using CGM or SMBG that are compatible with data transmission to the study diabetes management system (i.e. for CGM, FGM with a reader).
* Fasting glucose target is \< = 180 mg/dl (T2D)
* Subjects have home computer connected to the internet.
* Subjects have a smart phone compatible with study requirements.
* Subjects willing and able to sign a written informed consent form.

Exclusion Criteria:

* An episode of diabetic keto-acidosis within the month prior to study entry and/or severe hypoglycemia resulting in seizure or loss of consciousness in the month prior to enrolment.
* Concomitant diseases/ treatment that influence metabolic control or 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 patients' safety
* Relevant severe organ disorders (diabetic nephropathy, diabetic retinopathy, diabetic foot syndrome) or any secondary disease or complication of diabetes mellitus, such as:

  * Subject has unstable or rapidly progressive renal disease or is receiving dialysis
  * Subject has active proliferative retinopathy
  * Active gastroparesis
  * Subject has loss of kidney function as measured by estimated Glomerular Filtration Rate (eGFR) \<45 in the previous 3 months 4. Participation in any other interventional study 5. Female subject who is pregnant or planning to become pregnant within the planned study duration
* Subject is in the "honeymoon" phase - i.e. less than 0.5 insulin units/kg per day.
* Drug or alcohol abuse.

Primary outcomes:
measure: Sensor glucose percentage of time in hypoglycemia below 54 mg/dl
timeFrame: 12-16 weeks
measure: Sensor glucose percentage of time in hyperglycemia above 250 mg/dl
timeFrame: 12-16 weeks
Secondary outcomes:
measure: Percentage of readings within range of 70-180 mg/dl
timeFrame: 12-16 weeks
measure: Change in HbA1C post study treatment
timeFrame: 12-16 weeks
measure: Number of Serious Adverse Events
timeFrame: 12-16 weeks
Other outcomes:
measure: Percentage of readings above 180 mg/dl
timeFrame: 12-16 weeks
measure: Percentage of readings below 70 mg/dl
timeFrame: 12-16 weeks
measure: Mean sensor glucose
timeFrame: 11 weeks
measure: Glucose variability
timeFrame: 12-16 weeks
measure: Number of recommendations for changes in the treatment plan per patient
timeFrame: 12-16 weeks
measure: Number of recommendations for changes in the treatment plan per iteration
timeFrame: 12-16 weeks
measure: Number of physician overrides of the study system recommendations segment 1 only
timeFrame: 12-16 weeks
measure: Number of physician overrides of the study system recommendations
timeFrame: 12-16 weeks
measure: Total insulin dose
timeFrame: 12-16 weeks
measure: The amount of basal insulin dose
timeFrame: 12-16 weeks
measure: The amount of bolus insulin dose
timeFrame: 12-16 weeks
Locations:
city: Petach Tikva
country: Israel
facility: schneider children medical center of Israel
city: Petah-Tikva
country: Israel
facility: Rabin Medical Center- Belinson
Study officials:
affiliation: Rabin Medical Center
name: Moshe Phillip, MD
role: STUDY_DIRECTOR
affiliation: Rabin Medical Center
name: Revital Nimri, MD
role: PRINCIPAL_INVESTIGATOR
References: