Closing the Loop in Youth With Type 1 Diabetes in the Home Setting
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ClinicalTrials.gov Identifier: NCT01221467 |
Recruitment Status :
Completed
First Posted : October 15, 2010
Last Update Posted : September 24, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Type 1 Diabetes | Device: Overnight closed-loop | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 17 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | An Open-label, Single-centre, Randomised, 2-period Cross-over Study to Assess the Efficacy, Safety and Utility of Real-time Continuous Subcutaneous Glucose Monitoring Combined With Overnight Closed-loop Glucose Control in the Home Setting in Comparison With Real-time Continuous Subcutaneous Glucose Monitoring Alone in Adolescents With Type 1 Diabetes on Subcutaneous Insulin Infusion Pump Therapy. |
Study Start Date : | June 2012 |
Actual Primary Completion Date : | March 2013 |
Actual Study Completion Date : | March 2013 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Overnight closed-loop combined with real-time CGM |
Device: Overnight closed-loop
The closed-loop system is purpose-built and comprises a hand-held computer containing the algorithm and communicating with the CGM device and the insulin pump. |
Active Comparator: Real-time CGM alone |
Device: Overnight closed-loop
The closed-loop system is purpose-built and comprises a hand-held computer containing the algorithm and communicating with the CGM device and the insulin pump. |
- Primary Efficacy Outcome [ Time Frame: At least 7 days of valid CGM nights (midnight-7:30) ]The primary objective of the study is to assess the efficacy of continuous glucose monitoring (CGM) combined with overnight automated closed-loop glucose control in maintaining CGM glucose levels within the target range from 3.9 to 8.0 mmol/L, when compared with the use of CGM alone in the home setting.
- Secondary outcomes [ Time Frame: At least 7 days of valid CGM nights (midnight-7:30) ]
As a secondary research question, the safety of overnight automated closed-loop glucose control in terms of number of episodes of severe hypoglycaemia as well as the number of subjects experiencing severe hypoglycaemia and other adverse events.
Furthermore, the frequency and duration of use of the closed-loop system will be evaluated. Subjects' perception in terms of life-style change, daily diabetes management and fear of hypoglycaemia will be assessed using questionnaires and a qualitative interview.

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Ages Eligible for Study: | 12 Years to 18 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- The subject is between 12 and 18 years of age (inclusive)
- The subject has type 1 diabetes, as defined by WHO for at least 1 year or is confirmed C-peptide negative
- The subject will all have been insulin pump user for at least 3 months, with good knowledge of insulin self-adjustment as judged by the investigator
- The subject willing to perform regular finger-prick blood glucose monitoring, with at least 4 blood glucose measurements taken every day
- HbA1c ≤ 10 % based on analysis from central laboratory or equivalent
- The subject is literate in English
- Able to accommodate on site or in close proximity member(s) of study team for supervised closed-loop night(s)
Exclusion Criteria:
- Non-type 1 diabetes mellitus including those secondary to chronic disease
- Any other physical or psychological disease likely to interfere with the normal conduct of the study and interpretation of the study results as judged by the investigator
- Current treatment with drugs known to interfere with glucose metabolism, eg systemic corticosteroids, non-selective beta-blockers and MAO inhibitors etc
- Known or suspected allergy against insulin
- Subjects with clinical significant nephropathy, neuropathy or proliferative retinopathy as judged by the investigator
- Total daily insulin dose ≥ 2 IU/kg/day
- Pregnancy, planned pregnancy, or breast feeding
- Prolonged use of any continuous glucose monitoring devices over the last 1 month prior the study
- Severe visual impairment
- Severe hearing impairment
- Subjects using implanted internal pace-maker -

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01221467
United Kingdom | |
Department of Paediatrics, Weston paediatric diabetes centre | |
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ |
Responsible Party: | Dr Roman Hovorka, Principal Research Associate, University of Cambridge |
ClinicalTrials.gov Identifier: | NCT01221467 |
Other Study ID Numbers: |
APCam06 |
First Posted: | October 15, 2010 Key Record Dates |
Last Update Posted: | September 24, 2013 |
Last Verified: | September 2013 |
Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Autoimmune Diseases Immune System Diseases |