An 8-Day Initiation Protocol of Advanced Hybrid Closed Loop System In Children and Adolescents With Diabetes Type 1 On Multiple Daily Insulin Injection
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Sidra Medicine
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- TIR (70-180 mg/dl)
Study Overview
Brief Summary
One of the available Hybrid closed loop system is MiniMed 670G (Medtronic Diabetes, Northridge, CA, USA), which is indicated for children above 7 years old, adolescents and adults with Type 1 Diabetes. Several studies have shown improved HbA1c, time in target range, and SG variability in children, adolescents and adults with Type 1 Diabetes, where participants were experienced with using CSII therapy, assuming that the success of HCL systems depend on prior use of pump therapy. A recent study, published by diabetes team from Sidra Medicine, Doha has showed that children and adolescents with Type 1 Diabetes on MDI therapy can successfully initiate the HCL system, using a concise structured 10-day protocol, achieving better outcomes than in previous studies, where participants had previous experience with diabetes related technology and longer initiation process.
The AHCL system, Minimed 780G is CE-marked includes additional functionality aiming to provide further protections from highs. The user can choose the algorithm to target a glucose level of 100 or 120 mg/dL. Like for the MiniMed 670G HCL system, users can also choose the algorithm to temporarily target a glucose value of 150 mg/dL. In addition, the AHCL system has the ability to administer correction bolus automatically, targeting 120 mg/dL. The AHCL algorithm was evaluated with a model-based algorithm design platform incorporating a virtual patient simulator, where additional changes were made (lower target ranges and automated correction boluses ( )). A recent study including 12 patients with type 1 diabetes on AHCL system, has shown no episodes of hypoglycemia or diabetic ketoacidosis, while maintaining 99% time spent in closed loop and high time in ra1]\nge ( ). AHCL decreased Auto Mode exits and alerts, and improves glycaemia without compromising safety, despite multiple food and exercise challenges ( ).
Sidra Medicine is the only center for childhood diabetes in Qatar. Around 80% of type 1 diabetes patients are using a device (insulin pump/glucose sensor) and around 45% are using sensor-augmented pump (SAP)/HCL systems.
Detailed Description
This study is a single-arm, single-center, clinical investigation in subjects with type 1 diabetes on AHCL insulin pump in a period of 3 months.
The study will include an 9-month extension phase, to which participants may voluntarily decide to take part in, cumulating a total of one-year period duration. Visits wil be scheduled every 3 months, as per routine practice. TIR, HbA1c, demographics and clinical data will be analyzed on 3 months period.
A total of 33 subjects (age 7-17 years) will be enrolled in order to reach 30 subjects who will complete the 3 months study.
After reviewing the patient's eligibility and interest, the investigators will obtain informed consent and assent as appropriate. The investigators will start the clinical process for initiating an insulin pump, which is typically done with pre-pump classes. A clinically obtained HbA1c assessment will be performed via fingerstick and DCA 2000 at baseline and 3 months during the study.
Collection of demographics and medical history, data for diabetes devices (eg meters, sensors, pumps) and brief clinical physical exam including vital signs and skin assessment will be obtained via Hospital Electronic Medical File (Cerner Millennium) and will be kept as electronic data on a separate research server.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 7 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Clinical diagnosis of type 1 diabetes >1 year prior to consent date. Diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not required.
- •HbA1c < 12.5%
- •Age 7-17 years at the initiation of the system
- •Multiple Daily Injections (Basal Bolus therapy) with Total daily insulin use of great than 8.0 units per day over a 1-week period
- •Willing and able (access to internet from home) to download information into the Medtronic CareLink software
- •Clinically able to start the AHCL system
- •History of 3 clinic visits in the last year
Exclusion Criteria
- •DKA in the 6 months prior to screening visit
- •Untreated diabetes retinopathy, or other causes that ,in the investigator's opinion, precludes the individual from participating in the trial.
Outcomes
Primary Outcomes
TIR (70-180 mg/dl)
Time Frame: 3 months
Change from baseline to the first 3 months
TIR (70-180 mg/dl
Time Frame: 12 months
Change from baseline to the 12 months
Secondary Outcomes
- Sensor glucose wear(12 months)
- Auto Mode Usage(12 months)
- Diabetic Ketoacidosis(12 months)
- Severe Hypoglycemia(12 months)
- HbA1c change(12 months)