Investigating the effect of oral insulin on glycaemia

Phase 3

Active, not recruiting

Conditions: Type 1 Diabetes
Metabolic and Endocrine - Diabetes

Registration Number: ACTRN12622000764730

Lead Sponsor: Child and Adolescent Health Service

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Active, not recruiting

Sex: All

Target Recruitment: 11

Inclusion Criteria

1. T1D of at least 1 year duration,
2. C-peptide less than 0.1nmol/l (in the absence of hypoglycaemia)
3. Age 16 - 25 years
4. On hybrid closed loop system using Medtronic 770G/780G, Tandem t:slim or Ypso insulin pumps. (using closed loop system for = 70% of the time in last 2 weeks)
- No plans to change the management during the study period.
5. HbA1c =9.0%
6. Ready to meet the requirements of the protocol.
7. Has the ability to download the insulin pump if on Medtronic 670G (Medtronic 770G users have automatic download)
8. English speaking, living in an area with internet and cellular phone coverage

Exclusion Criteria

1. Recent significant change in HbA1c exceeding 1.5% over the past 3 to 4 months.
2. Use of any non-insulin glucose-lowering agent.
3. Pregnancy, comorbidities: Renal dialysis/transplant or glomerular filtration rate <60ml/min/m2, malabsorption, coeliac disease, active liver disease, islet cell/pancreatic transplant

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite outcome - Total insulin dose (units/kg/day) and proportion of basal and bolus insulin - assessed using pump data and insulin dose from Capsulin[ At Visit 1 (baseline), Visit 2 (week 1 post-intervention commencement), Visit 3 (week 6 post-intervention commencement) and Visit 4 (week 12 post-intervention commencement)]

Secondary Outcome Measures