A Randomized Clinical Trial to Assess the Efficacy of Adjunctive Closed Loop Control Versus Sensor-Augmented Pump Therapy in the Management of Type 1 Diabetes

A Randomized Clinical Trial to Assess the Efficacy of Adjunctive Closed Loop Control Versus Sensor-Augmented Pump Therapy in the Management of Type 1 Diabetes - the International Diabetes Closed Loop (iDCL) Trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON46319

Enrollment

Registered

2016-07-15

Start date

2017-04-18

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

diabetes mellitus

Interventions

Subjects of the intervention group will use at home the Control Range (CTR) Closed-Loop system for a period of 6 months. Subjects in the control groupwill use at home sensor augmented insulin pump t

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Diagnosis of type 1 diabetes for at least one year and using insulin for at least 1 year Use of an insulin pump for at least 6 months Age >= 18 HbA1c level =0.5 U/kg Access to internet and cell phone service at home

Exclusion criteria

Exclusion criteria: Medical need for chronic acetaminophen Introduction of any glucose-lowering agent (such as Pramlintide, Metformin, GLP-1, Liraglutide, SGLT2 inhibitors) within the three months prior to enrollment Hemophilia or any other bleeding disorder More than one diabetic ketoacidosis (DKA) in the past 6 months More than one severe hypoglycemia in the past 6 months Use of a closed-loop system within the last month prior to enrollment Employed by, or having immediate family members employed by TypeZero Technologies

Design outcomes

Primary

Measure	Time frame
- Difference in HbA1c improvement between the control-to-Range (CTR) Closed-Loop group and the sensor-controlled insulin pump group. - Difference in the sensor measured hypoglycemia between the control-to-Range (CTR) Closed-Loop group and the sensor-controlled insulin pump group. Outcome measures of the the training protoco includesl: a qualitative assessment of the control-to-Range (CTR) Closed-Loop system to use it on a large scale at home.	—

Measure

Time frame

- Difference in HbA1c improvement between the control-to-Range (CTR) Closed-Loop group and the sensor-controlled insulin pump group. - Difference in the sensor measured hypoglycemia between the control-to-Range (CTR) Closed-Loop group and the sensor-controlled insulin pump group. Outcome measures of the the training protoco includesl: a qualitative assessment of the control-to-Range (CTR) Closed-Loop system to use it on a large scale at home.

—

Secondary

Measure	Time frame
- Episodes of severe hypoglycemia - Episodes of diabetes ketoacidosis - Other serious adverse events	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)