Type 1 Diabetes, Type 2 Diabetes
Conditions
Keywords
Type 1 diabetes, Type 2 diabetes, Dose guidance system
Brief summary
A prospective, randomized, single blind, two-arms, multicenter study. The study aims to assess the safety of a dosing-guided system (DGS) that provides direct advice on insulin dosing recommendations and diabetes management to individuals with diabetes using insulin or starting basal insulin therapy, guided by their continuous glucose monitoring (CGM). The study population will include up to 45 individuals with diabetes, distributed as follows: 15 with Type 1 diabetes (T1D) and 15 with Type 2 diabetes (T2D), both on MDI therapy and 15 with T2D using or starting to use basal insulin. The study will include a 2- to 4-week run-in period followed by a 6-week intervention period.
Interventions
DEVICEDosing Guidance System to be used with both time and amount of insulin as input
Any insulin dosing event manually logged by the participant, the DGS will receive the time and amount of the dose as input
DEVICEDosing Guidance System to be used with only time of insulin as input
any insulin dosing event manually logged by the participant, the DGS will receive only the time of the dose as input
Sponsors
DreaMed Diabetes
Rabin Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
A prospective, randomized, single blind, two-arms, multicenter study
Eligibility
Sex/Gender
ALL
Age
6 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Documented T1D or T2D, for at least 6 months * Aged ≥ 6 years ≤ 75 years * HbA1c ≤ 11% * For Segment 1: Using basal-bolus MDI therapy, i.e. basal insulin and a bolus that is either: 1. Carbohydrate counting with carbohydrate ratio (CR) and correction factor (CF) 2. Fix dose for meal / meal estimation with CF * For Segment 2: Using or prescribed basal insulin * Participants using the following type of insulin as directed in the instructions for use: 1. Basal insulin: Glargine (including Rezvoglar, Semglee, Toujeo, Soliqua), Degludec (including Tresiba U-100, Tresiba U-200, Xultophy), Determir 2. Bolus insulin: regular insulin, rapid analogues (Insulin Aspart, Insulin Glulisine, Insulin Lispro) or ultra-rapid analogues (Fiasp, Lyumjev) * Participants willing to use FreesStyle Libre CGM according to manufacturer instructions, document insulin delivery, meals, and daily activities. * Participants have a smartphone compatible with study requirements. * Participants are willing and able to sign a written informed consent form to use their data. * Participants are willing to use the bolus calculator for insulin dosing (only for segment 1)
Exclusion criteria
1. Concomitant diseases/treatment that influence metabolic control or any significant diseases/conditions including psychiatric disorders and substance abuse or drug or alcohol abuse that in the opinion of the investigator is likely to affect the subject's ability to complete the study or compromise patients' safety. 2. Relevant severe organ disorders (diabetic nephropathy, diabetic retinopathy, diabetic foot syndrome) or any secondary disease or complication of diabetes mellitus, such as: 1. Subject has unstable or rapidly progressive renal disease or has eGFR \< 45 or is receiving dialysis 2. Subject has active proliferative retinopathy 3. Active gastroparesis 3. Participation in any other interventional study 4. Female participant who is pregnant or planning to become pregnant within the planned study duration 5. Individuals who are using one of the following types of insulin: 1. Intermediate-acting insulin (NPH) 2. Mixed insulin like: i. Premix NPH/ Regular (e.g. Humalin 70/30, Novolog 70/30) ii. Premix analogs (e.g, Novolog mix 70/30, Hu,alog mix 75, 25, Humalog Mix 50/50) c. Inhale insulin (e.g. Afrezza) 6. Hypoglycemia unawareness 7. Individuals who are treated with intravenous (IV) insulin injections, or a combination of insulin injections and/or IV insulin and insulin pump therapy. 8. Individuals who have extensive skin changes/diseases at the proposed application sites that could interfere with device placement or the accuracy of interstitial glucose measurements. 9. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensor glucose percentage of time in hypoglycemia below 54 mg/dL | Aafter 6 weeks of intervention period | Will be compared between the last two weeks of the run-in period and the last two weeks of the intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of events of glucose readings below 54 mg/dL | After 6 weeks of intervention period | An event is defined as a period of at least 15 minutes of glucose readings below 54 mg/dL. Will be compared between the last two weeks of the run-in period and the last two weeks of the intervention |
| Sensor glucose percentage of time in hyperglycemia above 250 mg/dL | After 6 weeks of intervention period | Will be compared between the last two weeks of the run-in period and the last two weeks of the intervention |
Other
| Measure | Time frame | Description |
|---|---|---|
| Percentage of glucose readings below 70 mg/dl | After 6 weeks of intervention period | Will be compared between the last two weeks of the run-in period and the last two weeks of the intervention |
| Mean sensor glucose | After 6 weeks of intervention period | Will be compared between the last two weeks of the run-in period and the last two weeks of the intervention |
| Glucose variability measured by Standard Deviation (SD) and CV% | After 6 weeks of intervention period | Will be compared between the last two weeks of the run-in period and the last two weeks of the intervention |
| Glucose Management Indicator (GMI) | After 6 weeks of intervention period | — |
| Total insulin dose and the amount of basal and/or bolus insulin dose | After 6 weeks of intervention period | — |
| Device satisfaction questioner | After 6 weeks of intervention period | — |
| Time to reach optimal insulin dose | After 6 weeks of intervention period | — |
| Percentage of glucose readings between 70- 180 mg/dl | After 6 weeks of intervention period | Will be compared between the last two weeks of the run-in period and the last two weeks of the intervention |
| Change in (Hemoglobin A1c) HbA1C post-study treatment | After 6 weeks of intervention period | — |
Countries
Israel, Slovenia
Contacts
Primary ContactAlona Hamou, Msc
Outcome results
None listed