Type 1 Diabetes Clinical Trial
Official title:
Evaluation Of Hybrid Closed Loop (HCL) System On-Boarding Protocol, For Patients With Type 1 Diabetes On Multiple Daily Insulin Injections (MDI) Therapy
The objective of this study is to assess structured group education onboarding protocol of the 670 G Hybrid Closed Loop (HCL) systems in achieving glucose control of patients on Multiple Daily Insulin Injections (MDI).
Status | Recruiting |
Enrollment | 40 |
Est. completion date | January 2022 |
Est. primary completion date | July 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: 1. Clinical diagnosis of type 1 diabetes. Diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not required. 2. HbA1c < 12.5% 3. Age18-65 years at the initiation of the 670G system 4. Multiple Daily Injections (Basal Bolus therapy) with Total daily insulin use of great than 8.0 units per day over a 1 week period 5. Willing and able (access to internet from home) to download information into the Medtronic CareLink software 6. Clinically planning to and be able to start the Medtronic 670G HCL system 7. History of 3 clinic visits in the last year 8. With history of cardiovascular event 1 year or more from the time of screening, must have clearance from a cardiologist. Exclusion Criteria: 1. Diabetic Ketoacidosis in the 6 months prior to screening visit 2. Type 2 diabetes 3. Hyperthyroidism at time of screening 4. Using Pramlintide, Dipeptidyl peptidase 4 (DPP-4) inhibitor, Glucagon-like peptide-1 (GLP-1) agonists, metformin, sodium-glucose transport protein 2 (SGLT2) inhibitors at time of screening. 5. Has taken any oral, injectable, or intravenous (IV) steroids within 8 weeks from time of screening visit, or plans to take any oral, injectable, or IV steroids during the course of the study. |
Country | Name | City | State |
---|---|---|---|
Qatar | Hamad Medical Corporation | Doha |
Lead Sponsor | Collaborator |
---|---|
Hamad Medical Corporation | Sidra Medicine |
Qatar,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The achievable percentage of time in range (TIR) 70 - 180 mg/dL for the whole study population after 3 months. | The achievable Time in Range (TIR) in the first 3 months of MiniMed 670G following onboarding of MDI to HCL by the protocol in a real-life setting. | 3 months | |
Secondary | percentage of patients achieving TIR > 67% in Time in Range (70-180 mg/dl) | 3 months | ||
Secondary | percentage of patients achieving TIR <3% Time below Range ( <70 mg/dl) | 3 months | ||
Secondary | percentage of patients achieving both TIR > 67% and <3% Time below Range | 3 months | ||
Secondary | Change in HBA1C from baseline | Change in HbA1c levels from previous treatment (multiple daily injections) compared to Minimed 670G treatment | 3 months | |
Secondary | Change in sensor glucose values from baseline | Change in sensor glucose values from previous treatment (multiple daily injections) compared to Minimed 670G treatment | 3 months | |
Secondary | Percentage of time above Range (>180 mg/dl) for the whole study population | Percentage of glucose values more than 180 mg/dl on Minimed 670G | 3 months | |
Secondary | Number of severe hypoglycemia episodes | 3 months | ||
Secondary | Number of Diabetic Ketoacidosis episodes | 3 months | ||
Secondary | Total daily insulin dose | 3 months | ||
Secondary | Percentage of time spend in Auto Mode | Percentage of time in Auto Mode, where Minimed 670G automatic adjusts the basal insulin dose according glucose levels | 3 months |
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