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Understanding the utilisation of an insulin-to-protein ratio in people with type 1 diabetes who follow a carbohydrate-restricted diet.

Understanding the utilisation of an insulin-to-protein ratio in people with type 1 diabetes who follow a carbohydrate-restricted diet.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619000208101
Enrollment
34
Registered
2019-02-13
Start date
2019-03-29
Completion date
2019-09-09
Last updated
2021-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Thirty six people with T1DM attending diabetes clinics at Capital and Coast Health will be invited to take part in a randomised controlled trial of mealtime insulin dosing for carbohydrate content only compared with dosing for both carbohydrate and protein. Participants will follow a carbohydrate-restricted diet (= 100g of carbohydrate per day) for three months. Before randomisation, participants who are not already following this diet will receive help to transition. All participants will have a subcutaneous freestyle libre continuous glucose monitor inserted and two weeks of glucose data will be collected. After baseline measurements, including HbA1c, participants will be randomised to either group, and receive training on estimating carbohydrate and protein content in their meals. Individual carbohydrate ratios will be established and the additional protein bolus be calculated using the insulin-to-protein ratio of half the carbohydrate ratio. After three months participants will have another subcutaneous freestyle libre continuous glucose monitor inserted. Two weeks of glucose data will be collected, and participants will have a blood test for HbA1c. The primary outcome is HbA1c at three months. The findings of this study will identify the effect of an additional insulin bolus based on dietary protein and carbohydrate on blood glucose in people with T1DM following a carbohydrate-restricted diet in real world conditions.

Interventions

Brief name: Mealtime insulin dosing for both carbohydrate and protein self-administered by sub-cutaneous injection. For 3 months, participants will self-administer a mealtime protein-based insulin bolus that is calculated using the insulin-to-protein ratio of half the carbohydrate ratio. This is in addition to insulin dosing based on mealtime carbohydrate and the participant's individualised carbohydrate ratio. This will be done using their standard insulin administration method and during thei

Brief name: Mealtime insulin dosing for both carbohydrate and protein self-administered by sub-cutaneous injection. For 3 months, participants will self-administer a mealtime protein-based insulin bolus that is calculated using the insulin-to-protein ratio of half the carbohydrate ratio. This is in addition to insulin dosing based on mealtime carbohydrate and the participant's individualised carbohydrate ratio. This will be done using their standard insulin administration method and during their normal daily routine. Training: We are expecting that participants will already be able to carbohydrate count. We will go over the participant's understanding with them. The training will be delivered by the researcher face-to-face at the centre for diabetes & endocrine research at Wellington hospital. Patient's will be given a written hand-out at the same time. This will occur once at the beginning of the study. Adherence will be recorded using diary recordings of diet and insulin dosing. There will also be once-weekly phone calls for the duration of the study. The freestyle libre is a continuous glucose monitor that consists of a small glucose sensor that sits under the skin and is attached to a water resistant patch on the skin. It reads blood glucose and trend information. A touchscreen reader device, when held near the patch, will give real-time glucose value. The sensor patch stays implanted for 14 days. It is applied by pressing the sensor onto the applicator and pressing the applicator onto the upper arm. It will be applied to the participants arm at a face to face meeting. The participant will then wear it as they go about their daily business for the next 14 days. They will have another meeting at the end of this period where it will be removed. This happens twice during the study, once at the beginning and once at the end.

Sponsors

Capital and Coast District Health Board
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

People with type 1 diabetes mellitus who follow a basal-bolus insulin regimen and attend diabetes clinics at Capital and Coast Health.

Exclusion criteria

Pregnant or planning pregnancy Breast-feeding Unstable diabetes control (HbA1c>85 mmol/mol) Kidney disease (EGFR<30 or on dialysis) Hypoglycaemia unawareness, defined as a recurrent failure to detect a significant fall in blood glucose below normal levels People who undertake more than 15 hours of moderate to intense exercise per week History of gastroparesis

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026