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Looping Whilst Restricting Carbohydrates

NCT ID: NCT03932630

Last Updated: 2022-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-31

Study Completion Date

2020-12-31

Brief Summary

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To investigate the efficacy, safety and utility of hybrid closed-loop glucose control during a low carbohydrate vs. iso-energetic balanced diet in individuals with type 1 diabetes.

Detailed Description

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Closed-loop systems combining an insulin pump, a glucose sensor and a dosing algorithm that adjusts insulin delivery in a glucose-responsive manner achieve significantly better glucose control than conventional therapy in type 1 diabetes. Achieving satisfactory postprandial glucose control, however, continues to be challenging. The main limitation is the delayed pharmacokinetics and -dynamics of subcutaneously administered insulin with peak actions between 1 and 2 hours. Conversely, glucose levels typically rise within 10minutes following carbohydrate intake. This mismatch largely explains the inability of current closed-loop systems to control postprandial glucose excursions and the increased risk of late postprandial hypoglycaemia in response to both user-derived meal bolus administration and reactive algorithm-driven insulin infusion.

Restricting carbohydrate may therefore significantly improve post-prandial glucose control whilst reducing hypoglycaemia. The efficacy of hybrid closed-loop operation in individuals with type 1 diabetes adhering to a low carbohydrate compared to a iso-caloric balanced diet has not been investigated to date.

Conditions

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Diabetes Type 1 Diabetes

Keywords

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artificial pancreas hybrid closed-loop low carbohydrate diet glucose control

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Study intervention

Group Type EXPERIMENTAL

Low carbohydrate diet

Intervention Type OTHER

The study intervention will be an eucaloric low carbohydrate diet (15-20 % of carbohydrates) for 2 weeks.

Control intervention

Group Type ACTIVE_COMPARATOR

balanced diet

Intervention Type OTHER

The control intervention will be a energy-matched balanced diet (50 % of carbohydrates) for 2 weeks.

Interventions

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Low carbohydrate diet

The study intervention will be an eucaloric low carbohydrate diet (15-20 % of carbohydrates) for 2 weeks.

Intervention Type OTHER

balanced diet

The control intervention will be a energy-matched balanced diet (50 % of carbohydrates) for 2 weeks.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Female and male subjects aged 18 years or older
* Diabetes mellitus Type 1 as definded by WHO for at least 2 years or C-peptide negative (\<100 pmol/L with concomitant blood glucose \> 4 mmol/L)
* hybrid-closed-loop Insulin therapy (Minimed 670G) for at least 2 months
* HbA1c \<= 9 %
* The subject is willing and capable of adhering to the diet plan.

Exclusion Criteria

* Physical or psychological condition likely to interfere with the normal conduct of the study and interpretation of the study results as judged by the investigator.
* Excess alcohol consumption (\> 3 units/day for men, \> 2 units/day for women)
* Pregnancy, planned pregnancy or breast feeding
* Current participation in another clinical trial
* Total daily insulin dose \>2 IU/kg/day
* Nephrolithiasis
* Hereditary dyslipidemia
* Liver steatosis
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role lead

Responsible Party

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Lia Bally

Head of Metabolic Science Research Group

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lia Bally, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Inselspital, Bern University Hospital, University of Bern

Locations

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University Department of Endocrinology, Diabetology, Clinical Nutrition and Metabolism

Bern, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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LINEAR

Identifier Type: -

Identifier Source: org_study_id