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Looping Whilst Restricting Carbohydrates

  • Clinicaltrials.gov identifier

    NCT03932630

  • Recruitment Status

    Recruiting

  • First Posted

    May 1, 2019

  • Last update posted

    December 17, 2019

Study Description

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.

  • Condition or Disease:Type 1 Diabetes
    Diabetes
  • Intervention/Treatment: Other: Low carbohydrate diet
    Other: balanced diet
  • Phase: N/A

Detailed Description

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.

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 15 participants
  • Allocation: Randomized
  • Intervention Model: Crossover Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: Looping Whilst Restricting Carbohydrates (LINEAR) - a Randomised Two-Period Crossover Trial
  • Actual Study Start Date: December 2019
  • Estimated Primary Completion Date: December 2020
  • Estimated Study Completion Date: December 2020

Arms and interventions

Arm Intervention/treatment
Experimental: Study intervention
Other: Low carbohydrate diet
The study intervention will be an eucaloric low carbohydrate diet (15-20 % of carbohydrates) for 2 weeks.
Active Comparator: Control intervention
Other: balanced diet
The control intervention will be a energy-matched balanced diet (50 % of carbohydrates) for 2 weeks.

Outcome Measures

  • Primary Outcome Measures: 1. Percentage of time in target glucose range (3.9 - 10.0 mmol/L) [ Time Frame: 2 weeks ]
    The percentage of time in target glucose range will be assessed using continuous glucose monitoring (CGM).
  • Secondary Outcome Measures: 1. Percentage of time above target (>10 mmol/L) [ Time Frame: 2 weeks ]
    The percentage of time below target (>10 mmol/L) will be assessed using continuous glucose monitoring (CGM).
  • 2. Percentage of time below target (<3.9 mmol/L) [ Time Frame: 2 weeks ]
    The percentage of time below target (<3.9 mmol/L) will be assessed using continuous glucose monitoring (CGM).
  • 3. Percentage of time in hypoglycemia (<3.0 mmol/L) [ Time Frame: 2 weeks ]
    The percentage of time in hypoglycemia (<3.0 mmol/L) will be assessed using continuous glucose monitoring (CGM).
  • 4. Hypoglycemia burden quantified as the area under the curve (AUC) with glucose < 3 mmol/L [ Time Frame: 2 weeks ]
    Hypoglycemia burden will be assessed using continuous glucose monitoring (CGM).
  • 5. Percentage of time in hyperglycemia (>16.7 mmol/L) [ Time Frame: 2 weeks ]
    The percentage of time in hyperglycemia (>16.7 mmol/L) will be assessed using continuous glucose monitoring (CGM).
  • 6. Mean glucose levels (mmol/l) [ Time Frame: 2 weeks ]
    Mean sensor glucose levels will be assessed using continuous glucose monitoring (CGM).
  • 7. Total daily insulin dose (U) [ Time Frame: 2 weeks ]
    Total daily insulin dose will be recorded by the insulin pump
  • 8. Daily manual bolus Insulin dose (U) [ Time Frame: 2 weeks ]
    Daily manual bolus insulin dose will be recorded by the insulin pump
  • 9. 2 hour postprandial glucose increment (mmol/) [ Time Frame: 2 weeks ]
    2 hour postprandial glucose increment will be assessed using continuous glucose monitoring (CGM).
  • 10. Within-day standard deviation of glucose (mmol/l) [ Time Frame: 2 weeks ]
    Within-day standard deviation of glucose will be assessed using continuous glucose monitoring (CGM).
  • 11. Within day coefficient of variation of glucose (%) [ Time Frame: 2 weeks ]
    Within day coefficient of variation of glucose will be assessed using continuous glucose monitoring (CGM).
  • 12. Between days coefficient of variation of glucose (%) [ Time Frame: 2 weeks ]
    Between days coefficient of variation of glucose will be assessed using continuous glucose monitoring (CGM).
  • 13. Night-time percentage of time in target glucose range (3.9 - 10.0 mmol/L) [ Time Frame: Between 00:00-06:00 over 2 weeks ]
    Percentage of time in target glucose range will be assessed using continuous glucose monitoring (CGM).
  • 14. Night-time percentage of time above target (> 10.0 mmol/L) [ Time Frame: Between 00:00-06:00 over 2 weeks ]
    Percentage of time above target will be assessed using continuous glucose monitoring (CGM).
  • 15. Night-time percentage of time below target (< 3.9 mmol/L) [ Time Frame: Between 00:00-06:00 over 2 weeks ]
    Percentage of time below target will be assessed using continuous glucose monitoring (CGM).
  • 16. Night-time percentage of time in hypoglycemia (< 3.0 mmol/L) [ Time Frame: Between 00:00-06:00 over 2 weeks ]
    Percentage of time in hypoglycemia will be assessed using continuous glucose monitoring (CGM).
  • 17. Night-time percentage of time in hyperglycemia (> 16.7 mmol/L) [ Time Frame: Between 00:00-06:00 over 2 weeks ]
    Percentage of time in hyperglycemia will be assessed using continuous glucose monitoring (CGM).
  • 18. Night-time mean glucose levels [ Time Frame: Between 00:00-06:00 over 2 weeks ]
    Mean sensor glucose levels will be assessed using continuous glucose monitoring (CGM).
  • 19. Within night-time standard deviation of glucose (mmol/l)compared to within daytime period (06: - 24:00) standard deviation of glucose (mmol/l) [ Time Frame: Between 00:00-06:00 over 2 weeks ]
    Standard deviation of glucose will be assessed using continuous glucose monitoring (CGM).
  • 20. Within nighttime coefficient of variation of glucose(%) [ Time Frame: Between 00:00-06:00 over 2 weeks ]
    Coefficient of variation of glucose (%) will be assessed using continuous glucose monitoring (CGM).
  • 21. Change from baseline in lipid profile [ Time Frame: 2 weeks ]
    Plasma Lipid profile (total Cholesterol, LDL-Cholesterol, HDL-Cholesterol, Triglycerides)
  • 22. Total daily calorie intake (kcal/day) [ Time Frame: 2 weeks ]
    Total daily calorie intake will be assessed based on photo-documentation of dietary intake
  • 23. Mean beta-hydroxy butyrate level [ Time Frame: 2 weeks ]
    based on download of blood Ketone meter
  • 24. Change from baseline in fasting plasma metabolome [ Time Frame: 2 weeks ]
    Fasting serum sampling
  • 25. Incidence of (serious) adverse events [ Time Frame: 12 weeks ]
    Incidence of severe hypoglycaemia, signficant hyperglycaemia with ketonemia, other SAEs, adverse events, adverse defice effects and device deficiencies
  • 26. Percentage of time when pump was in Auto-mode [ Time Frame: 2 weeks ]
    Based on pump data download

Eligibility Criteria

  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

Criteria

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
( 4 mmol/L)

- hybrid-closed-loop Insulin therapy (Minimed 670G) for at least 2 months

- HbA1c 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

Contacts and Locations

Contacts

Contact: Lia Bally, MD PhD +41 (0)31 632 36 77 lia.bally@insel.ch

Locations

Switzerland
University Department of Endocrinology, Diabetology, Clinical Nutrition and Metabolism
Bern

Sponsors and Collaborators

University Hospital Inselspital, Berne

Investigators

Principal Investigator: Lia Bally, MD PhD Inselspital, Bern University Hospital, University of Bern

More Information

  • Responsible Party: University Hospital Inselspital, Berne
  • ClinicalTrials.gov Identifier: NCT03932630 History of Changes
  • Other Study ID Numbers: LINEAR
  • First Posted: May 1, 2019 Key Record Dates
  • Last Update Posted: December 17, 2019
  • Last Verified: December 2019
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Product Manufactured in and Exported from the U.S.: Yes
  • Keywords provided by University Hospital Inselspital, Berne: artificial pancreas
    glucose control
    hybrid closed-loop
    low carbohydrate diet
  • Additional relevant MeSH terms: Diabetes Mellitus