Comparison of an Artificial Pancreas Versus Threshold Low Glucose Suspend in Type 1 Diabetic Children

NCT ID: NCT02509429

Last Updated: 2018-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-16
• Study Completion Date: 2016-12-31

Brief Summary

The objective of this study is to assess the efficacy of an Artificial Pancreas system which includes a Control-To-Range algorithm, versus standard Insulin Pump Therapy with Threshold Low glucose Suspend feature. 24 Children aged from 7 to 12 will be recruted in 4 clinical centres. After a 2 week run-in period, they will attend two investigational sessions of 65 hours in home-like settings. During each session, the CTR algorithm or the TLGS feature will be activated, depending on the randomization. The main endpoint is the time spent below 70mg/dL between 22:00 and 07:00.

Detailed Description

The study is an open randomized control trial preceded by a run-in period and follows a cross-over design.After inclusion, the therapy will be moved to sensor augmented pump therapy with a dedicated training to continuous glucose monitoring using study system (study CGM). During 2 to 3 weeks, the patient will use his/her usual insulin pump and the study CGM (run-in period). At the end of this period, the patient and the relative will be admitted in a parents'house or hotel/resort nearby the hospital for 65 hours to undergo the first interventional session. Admission will be at 17:00 Day 1. The investigator will connect wirelessly the study pump and CGM to the study platform DiAs and remote monitoring will be activated. Until 08:00 Day 2, insulin delivery will be managed in open-loop mode, i.e. insulin doses will be decided according to capillary glucose measurements. From 08:00 Day 2, one algorithm will be activated according to the randomization order, i.e. either the threshold low glucose suspend (TLGS) algorithm (threshold will be set at 70 mg/dl) or the closed-loop algorithm. Insulin delivery will then be managed in open-loop mode with activated TLGS or by the closed-loop algorithm until 08:00 Day 4. In both cases, meals will be of free content and taken around 09:00, 13:00, 17:00 and 20:00. Meal insulin doses will be managed according to pre-meal glucose level and CHO meal content in open-loop mode with TLGS, or according to DiAs bolus calculator suggestion in closed-loop mode. Patient and relative will be encouraged to move in parents'house or hotel/resort and surroundings between meals. The algorithm will be inactivated at 08:00 Day 4. The study pump will be removed and replaced by patient's usual pump. The patient and the relative will be released at 10:00 after breakfast. Study CGM will still be used at home for 2 to 4 weeks until the second interventional session. This session will be similar to the first one but the alternative algorithm will be activated. Patient will come back to pre-study insulin therapy from 08:00 Day 4 and be released at 10:00 when second session is completed.

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control-to-Range algorithm and Threshold Low Glucose Suspend

On this arm, patients will realize two investigational sessions:

• the first with Control-to-Range algorithm (CTR),
• the second with Threshold Low Glucose Suspend (TLGS).

Group Type: EXPERIMENTAL

Insulin therapy (aspart, lispro ou glulisine) with Control-to-Range algorithm

Intervention Type: DEVICE

The insuline used is usual patient insuline. There is no specific insulin for this protocol

Insulin therapy ((aspart, lispro ou glulisine) withThreshold Low Glucose Suspend

Intervention Type: DEVICE

The insuline used is usual patient insuline. There is no specific insulin for this protocol

Threshold Low Glucose Suspend and Control-to-Range algorithm

On this arm, patients will realize two investigational sessions:

• the first with Threshold Low Glucose Suspend (TLGS),
• the second with Control-to-Range algorithm (CTR).

Group Type: EXPERIMENTAL

Insulin therapy (aspart, lispro ou glulisine) with Control-to-Range algorithm

Intervention Type: DEVICE

The insuline used is usual patient insuline. There is no specific insulin for this protocol

Insulin therapy ((aspart, lispro ou glulisine) withThreshold Low Glucose Suspend

Intervention Type: DEVICE

The insuline used is usual patient insuline. There is no specific insulin for this protocol

Interventions

Insulin therapy (aspart, lispro ou glulisine) with Control-to-Range algorithm

The insuline used is usual patient insuline. There is no specific insulin for this protocol

Intervention Type: DEVICE

Insulin therapy ((aspart, lispro ou glulisine) withThreshold Low Glucose Suspend

The insuline used is usual patient insuline. There is no specific insulin for this protocol

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Age from 7 to 12

2. Puberty status at Prader 1

3. Diabetes diagnosed according to WHO criteria since more than 1 year

4. Fasting plasma C-peptide level <0.2 ng/ml for a fasting blood glucose level < 180 mg/dl

5. At least one positiveness for plasma antibodies against pancreatic islets: IAA, IA2, GAD, ICA or ZnT8, since diagnosis of diabetes

6. Treatment of diabetes by insulin pump since more than 6 months

7. HbA1c level below 8.5%

8. Trained in carbohydrate counting

9. Lack of any associated disease or therapy (except insulin) affecting glucose metabolism

10. Willingness to follow all study procedures

11. Informed consent signed by patient and parent or legally responsible party

12. Patient must be affiliated or beneficiary of a social medical insurance

Exclusion Criteria

1. Unwillingness of one parent or the legally responsible party to be present during all study procedures

2. Expected use of acetaminophen-containing drugs

3. Any disease or therapy (except insulin) affecting glucose metabolism during previous month

4. Impaired cognitive or psychological abilities which may result in defective adherence to study procedures

5. Active enrollment in another clinical trial or participation in a study within 30 days or participation in previous studies resulting in a cumulated annual income which would exceed 4500 €

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU d'Angers

Angers, , France

CHU Montpellier - Hôpital Lapeyronie

Montpellier, , France

AP-HP, Hôpital Robert Debré

Paris, , France

CHU de Tours, Hôpital Clocheville

Tours, , France

Countries

France

References

Renard E, Tubiana-Rufi N, Bonnemaison-Gilbert E, Coutant R, Dalla-Vale F, Farret A, Poidvin A, Bouhours-Nouet N, Abettan C, Storey-London C, Donzeau A, Place J, Breton MD. Closed-loop driven by control-to-range algorithm outperforms threshold-low-glucose-suspend insulin delivery on glucose control albeit not on nocturnal hypoglycaemia in prepubertal patients with type 1 diabetes in a supervised hotel setting. Diabetes Obes Metab. 2019 Jan;21(1):183-187. doi: 10.1111/dom.13482. Epub 2018 Aug 21.

Reference Type: DERIVED

PMID: 30047223 (View on PubMed)

Other Identifiers

9525

Identifier Type: -

Identifier Source: org_study_id