NCT03755479

Evaluation of Minimed 670G in T1D Patients on Multiple Daily Injection

Completed Last updated 6 September 2019

What this trial tests

trial testing Hybrid Closed Loop Insulin Pump Minimed 670G in Diabetes Mellitus, Type 1 in 30 participants. Completed in 11 August 2019.

Timeline

1 February 2019

Primary endpoint
8 August 2019

11 August 2019

Quick facts

Lead sponsor	Sidra Medicine
Status	Completed
Study type	OBSERVATIONAL
Enrollment	30
Start date	1 February 2019
Primary completion	8 August 2019
Estimated completion	11 August 2019
Sites	1 location across Qatar

Drugs / interventions tested

• Hybrid Closed Loop Insulin Pump Minimed 670G

Conditions studied

• Diabetes Mellitus, Type 1 — all drugs for Diabetes Mellitus, Type 1 →

Sponsor

Sidra Medicine

Who can join

Adults 6 to 17, any sex, with Diabetes Mellitus, Type 1. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Introduction. Sensor Augmented Pump has demonstrated superiority over insulin pump and Multiple Daily Injection (MDI) in achieving optimal glucose control and can improve quality of life in Type 1 Diabetes (T1D) patients. Hybrid closed loop (HCL) insulin pump Minimed 670G is a FDA approved device and European Conformity (CE) mark with SmartGuard technology and closed loop algorithm, which will allow the patients to improve their diabetes management. Hybrid closed loop insulin pump Minimed 670G monitors glucose in the subcutaneous tissues and automatically adjusts the delivery of rapid acting insulin as basal rate based on the user's glucose reading. SmartGuard technology in insulin pump, based on user's sensor glucose values can predict when glucose is approaching low levels, 30 minutes in advance and automatically stop insulin delivery. When user's glucose levels recover, SmartGuard will automatically resume insulin delivery. CareLink is personal software, which downloads the data from insulin pump, glucose sensor and glucometer to visualize diabetes information with charts, statistics and events that help patient and health provider to identify and understand patterns and trends The objective of this study is to assess structured group education on boarding protocol of the HCL Minimed 670 G in achieving glucose control of patients on MDI.

Methods. This study is a single-arm, single-center, clinical investigation in subjects with type 1 diabetes on HCL insulin pump (Minimed 670G) in a period of 3 months. A total of 30 subjects (age 6 - 17) will be enrolled in order to reach 26 subjects who will complete the HCL study. The investigators will start the clinical process for initiating an insulin pump, which is typically done with pre-pump classes. HbA1c, derived from CGM will be performed at baseline and 3 months during the study. The following parameters will be analyzed: % patients achieving Time in Range (TIR) \> 67% from 70 mg/dl to 180 mg/dl; % patients achieving TIR \<3%, below time in range (\<70 mg/dl) and % patients achieving both TIR \> 67% and \<3% time below Range. 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, North Kansas City, US) and will be kept as electronic data on a separate research server.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. One-year experience of hybrid closed-loop system in children and adolescents with type 1 diabetes previously treated with multiple daily injections: drivers to successful outcomes.
   Petrovski G, Al Khalaf F, Campbell J, Umer F, et al · · 2021 · cited 45× · PMID 33044604 · DOI 10.1007/s00592-020-01607-4
2. Glycemic outcomes of Advanced Hybrid Closed Loop system in children and adolescents with Type 1 Diabetes, previously treated with Multiple Daily Injections (MiniMed 780G system in T1D individuals, previously treated with MDI).
   Petrovski G, Al Khalaf F, Campbell J, Day E, et al · · 2022 · cited 41× · PMID 35351095 · DOI 10.1186/s12902-022-00996-7
3. 10-Day structured initiation protocol from multiple daily injection to hybrid closed-loop system in children and adolescents with type 1 diabetes.
   Petrovski G, Al Khalaf F, Campbell J, Fisher H, et al · · 2020 · cited 21× · PMID 31953687 · DOI 10.1007/s00592-019-01472-w
4. 56^th EASD Annual Meeting of the European Association for the Study of Diabetes : 21-25 September 2020.
   · 2020 · cited 9× · PMID 32840677 · DOI 10.1007/s00125-020-05221-5