Prevention of nocturnal hypoglycaemia with closed-loop insulin delivery in children and adolescents with type 1 diabetes (T1D)

Three randomised studies to assess closed-loop overnight glucose control as compared to standard pump therapy, copying with variable evening intake and afternoon exercise in youngsters with type 1 diabetes (T1D)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN18155883

Enrollment

Registered

2009-07-02

Start date

2007-04-12

Completion date

Unknown

Last updated

2015-01-13

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

Conditions

Type 1 diabetes Nutritional, Metabolic, Endocrine Insulin-dependent diabetes mellitus

Interventions

The three studies will take place as follows: 1. Comparison of closed loop system with standard CSII (APCam01): In random fashion, twelve subjects aged 5 to 18 years were treated by overnight closed-

rapid versus slow, P = 0.001, paired t-test) but matched for carbohydrates (129 +/- 34 versus 129 +/- 34 g

P = NS). The carbohydrate amount corresponded to the largest meal eaten over the three preceding months. Prandial insulin doses were comparable (17 +/- 6 versus 17 +/- 7 U) and were calculated accordi

four subjects participated previously in APCam01. One week before the first study occasion, a ramped treadmill protocol was used to estimate the peak VO2 as an indicator of the maximum oxygen uptake 1

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Young subjects stratified into age for each of the three trials: 1.1. Trial 1: Aged 5 to 18 years, either sex 1.2. Trial 2: Aged 12 to 18 years, either sex 1.3. Trial 3: Aged Post-pubertal to 18 years, either sex 2. Type 1 diabetes for at least 6 months or confirmed C-peptide negative

Exclusion criteria

Exclusion criteria: 1. Any other physical or psychological disease or medication likely to interfere with the normal conduct of the study and interpretation of the study results 2. Experienced recurrent severe hypoglycaemic unawareness 3. Clinical significant nephropathy, neuropathy or proliferative retinopathy

Design outcomes

Primary

Measure	Time frame
Overnight glucose control including the assessment of variability and frequency of hypoglycaemic events. Measured from the start of the closed-loop (20:00 or 18:30) until 08:00 the next day, and from 00:00 until 08:00 the day after.	—

Secondary

Measure	Time frame
1. The time spent in A+B and E+F Grades of the glycaemic control grading scheme 2. The total overnight insulin dose 3. Endocrine effects of exercise on growth hormone (GH), insulin-like growth factor 1 (IGF-1), insulin-like growth factor binding protein 1 (IGFBP-1) and counter-regulatory hormones Measured from the start of the closed-loop (20:00 or 18:30) until 08:00 the next day, and from 00:00 until 08:00 the day after.	—

Measure

Time frame

1. The time spent in A+B and E+F Grades of the glycaemic control grading scheme 2. The total overnight insulin dose 3. Endocrine effects of exercise on growth hormone (GH), insulin-like growth factor 1 (IGF-1), insulin-like growth factor binding protein 1 (IGFBP-1) and counter-regulatory hormones Measured from the start of the closed-loop (20:00 or 18:30) until 08:00 the next day, and from 00:00 until 08:00 the day after.

—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 1, 2026