Looping Whilst Restricting Carbohydrates

NCT03932630 | Withdrawn

• 1 other identifier: LINEAR
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes; Type 1 Diabetes

Keywords

artificial pancreas; hybrid closed-loop; low carbohydrate diet; glucose control

Outcome Measures

Primary Outcomes (1)

• Percentage of time in target glucose range (3.9 - 10.0 mmol/L)

  The percentage of time in target glucose range will be assessed using continuous glucose monitoring (CGM).

  2 weeks

Secondary Outcomes (26)

• Percentage of time above target (>10 mmol/L)

  2 weeks

• Percentage of time below target (<3.9 mmol/L)

  2 weeks

• Percentage of time in hypoglycemia (<3.0 mmol/L)

  2 weeks

• Hypoglycemia burden quantified as the area under the curve (AUC) with glucose < 3 mmol/L

  2 weeks

• Percentage of time in hyperglycemia (>16.7 mmol/L)

  2 weeks

Study Arms (2)

Study intervention

EXPERIMENTAL

Other: Low carbohydrate diet

Control intervention

ACTIVE COMPARATOR

Other: balanced diet

Interventions

Low carbohydrate diet OTHER

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

Study intervention

balanced diet OTHER

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

Control intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

University Department of Endocrinology, Diabetology, Clinical Nutrition and Metabolism

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 1

Interventions

Diet, Carbohydrate-Restricted

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Lia Bally, MD PhD

  Inselspital, Bern University Hospital, University of Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Metabolic Science Research Group

Study Record Dates

• First Submitted: April 28, 2019
• First Posted: May 1, 2019
• Study Start: December 1, 2019
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: December 19, 2022

Record last verified: 2022-12

Locations

CH (1)