se of the Hybrid Closed Loop therapy in hypoglycaemia awareness in people with Type 1 diabetes

Recruiting

• Conditions: Type 1 Diabetes Mellitus; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12616000909426
• Lead Sponsor: Princess Margaret Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-07-08
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

1. Aged 12 to 55 years
2. Diagnosed with type 1 diabetes
3. C-peptide negative (less than 0.05 nmol/L)
4. On CSII for greater than or equal to 3 months
5. Impaired awareness of hypoglycaemia: greater than or equal to a score of 4 on Gold’s questionnaire
6. Understands study protocol requirements and agrees to comply with them

Exclusion Criteria

1. Has adrenal insufficiency
2. Has growth hormone insufficiency
3. Has multiple pituitary hormone deficiency
4. Is pregnant
5. Chronic kidney disease (eGFR<45mL/min.1.73m2)
6. Any non-insulin glucose lowering agent, for example metformin SGLT2 inhibitor or GLP-1 analogues within the last 3 months
7. Oral steroid use within the last 3 months
8. Cardiovascular disease:
a. Uncontrolled hypertension (diastolic blood pressure >100mmHg and/or sustained systolic level (3 successive readings) > 160mmHg). Subjects taking antihypertensive medication will NOT be excluded provided they are maintained at a stable dose for 3 months prior to screening
b. Has a history of acute myocardial infarction, heart failure, angina, transient ischemic attack (TIA), cerebrovascular accident (CVA), or thromboembolic disease.
9. Has serious or unstable medical or psychological conditions which, in the opinion of the investigator, would compromise the ability to meet protocol requirements.
10. Poor visual acuity that precludes patients from using the pump technology
11. Any additional condition(s) that in the investigator’s opinion would warrant exclusion from the study or prevent the subject from completing the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adrenergic response to a hypoglycaemia.<br><br>This will be assessed measuring the epinephrine and norepinephrine response to hypoglycaemia during a hyperinsulinemic, hypoglycaemic clamp using high performance liquid chromatography.<br><br>A sub analysis of the adrenergic response to a hypoglycaemia who at baseline clamp have an epinephrine increase that is less than 2 fold is planned.[The hyperinsulinaemic, hypoglycaemic clamp will take place before and after the 6 weeks intervention/control period.]