Time to Moderate and Severe Hyperglycemia and Ketonemia Following an Insulin Pump Occlusion

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

A BHB level of 3.0 mmol/L is necessary but not sufficient for the diagnosis of diabetic ketoacidosis, which also requires evidence of acidosis.

“A BHB level of 3.0 mmol/L is necessary but not sufficient for the diagnosis of diabetic ketoacidosis, which also requires evidence of acidosis.7”

• cites [7] sourcePartly supported

  The Diagnostic Criteria discussion (page unavailable) requires elevated ketones and metabolic acidosis, and the ketone-testing discussion identifies β-hydroxybutyrate ≥3.0 mmol/L as a useful diagnostic threshold. But the report also allows ketones to be assessed by other methods, so it does not say that a measured BHB level of 3.0 mmol/L is necessary in every case. It additionally requires hyperglycemia or a history of diabetes. (LLM, conf=0.85)

  Experimental — accuracy not yet measured

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

The incidence of adverse insulin pump events is between 0.5 and 5 events per person-year, and these often do not require hospitalization.

“Others have found that the incidence of adverse insulin pump events is between 0.5 and 5 events per person-year, which often do not require hospitalization. 2”

• cites [2] sourceSupported

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

In a nationwide type 1 diabetes registry, 96.6% of participants had experienced at least one insulin infusion set failure per year, and 41.4% encountered at least one such failure per month.

“A study using self-reported surveys for a nationwide type 1 diabetes (T1D) registry showed that 96.6% of the participants had experienced at least one insulin infusion set failure per year, and 41.4% encountered at least one such failure per month. 1”

• cites [1] sourcePartly supported

  The Results report that 96.6% of respondents had at least one insulin infusion site failure every 12 months and 41.4% had at least one per month. The Study design describes a voluntary survey distributed through the T1D Exchange Online Community and social media, not a nationwide type 1 diabetes registry; eligibility also included people with type 2 diabetes using an insulin pump. (LLM, conf=0.88)

  Experimental — accuracy not yet measured

Probably not a substantial claim: may not pass S3 (load-bearing).

Insulin pump occlusion is not uncommon.

“Insulin pump occlusion is not uncommon.”

• cites [1] sourcePartly supported

  The Results report that insulin infusion site failures were common, and the Introduction lists occlusion among their usual causes. The paper does not report how often occlusion itself occurs, so its findings support the broader point about site failure but not the claim's occlusion-specific frequency. (LLM, conf=0.82)

  Experimental — accuracy not yet measured

May combine two claims.

The UVA/Padova T1D simulator consists of a fully identified maximal model of glucose metabolism in T1D and a virtual population of 100 adult PwDs displaying key metabolic behaviors observed in the general population of individuals with T1D.

“we used the University of Virginia (UVA)/Padova T1D simulator, which consists of a fully identified maximal model of glucose metabolism in T1D 18 and a virtual population of 100 adult PwDs displaying key metabolic behaviors observed in the general population of individuals with T1D.[18][19][20][21]”

• cites [18] sourceNot checked — no full text of the source
• cites [19]Not checked — no full text of the source
• cites [20] sourcePartly supported

  The Subjects and Methods passage describes a glucose–insulin model and 100 virtual adults, and the Discussion says the updated virtual population represents the T1D population observed in clinical trials. Our copy does not describe the model as “fully identified” or “maximal,” and its evidence for population representativeness is framed around clinical-trial observations rather than the general T1D population. (LLM, conf=0.87)

  Experimental — accuracy not yet measured

Probably not a substantial claim: may not pass S3 (load-bearing).

Children, especially younger children four to nine years old, are particularly sensitive to interruption of insulin infusion.

“This could be important because children, especially younger children four to nine years old, are particularly sensitive to interruption of insulin infusion.24”

• cites [24] sourceSupported

Probably not a substantial claim: may not pass S3 (load-bearing).

A prior study reported that younger children aged four to nine years were more sensitive to pump interruption than older children aged 10 to 14 years.

“A prior study did report that younger children aged four to nine years were more sensitive to pump interruption than older children aged 10 to 14 years.24”

• cites [24] sourceSupported

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

The authors would also have included simulation studies, but none were identified.

“We would also have included simulation studies, but none were identified.”

May combine two claims.

None of the eight included studies included children, and none were simulation studies.

“None of the eight studies included children, and none were simulation studies.”

Classified as probably not a substantial claim.

Five studies were excluded because they did not use a rapid-acting insulin analog.

“Five studies were excluded because they did not use a rapid-acting insulin analog.”

Classified as probably not a substantial claim.

Full-text review resulted in eight studies for data extraction.

“Full-text review resulted in eight studies for data extraction [10][11][12][13][14][15][16][17] (Table 2).”

Probably not a substantial claim: may not pass S3 (load-bearing).

None of the eight included studies displayed the time course of BG or BHB for individuals, only the average across all study participants.

“Also, none of the studies displayed the time course of BG or BHB for individuals, only the average across all study participants.”

Classified as probably not a substantial claim.

Simulation modeling is not available for BHB accumulation.

“Simulation modeling is not available for BHB accumulation.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

The abstract review yielded 26 articles, and 98 were excluded.

“The abstract review yielded 26 articles (98 were excluded).”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

The initial PubMed search yielded 73 publications; another 28 were identified by individual authors, and 13 through review of bibliographies.

“The initial PubMed search yielded 73 publications.Another 28 were identified by individual authors, and 13 through review of bibliographies of the identified studies (Figure 1).”

May combine two claims.

Based on the simulation, BG can rise to level 1 hyperglycemia within 3.0-5.25 hours and to level 2 hyperglycemia within 4.0-7.75 hours.

“Based on the simulation, the BG can rise to level 1 and level 2 hyperglycemic concentrations, respectively, within 3.0-5.25 hours and 4.0-7.75hours.”

• AssumptionThe authors state this as an assumption: In the simulation, virtual participants are fasting at the moment of pump failure (no carbohydrate on board), have consistently received their usual basal insulin infusion rate before the occlusion, and consume no carbohydrates during the 16-hour simulation.

May combine two claims.

Using the average rate of increase from the study with the highest rate of increase of BG, it would take 4.7 or 6.8 hours to reach a BG level of 300 or 400 mg/dL, respectively, starting at a BG of 120 mg/dL.

“Using the average rate of increase from the study with the highest rate of increase of BG, it would take 4.7 or 6.8 hours to reach a BG level of 300 or 400 mg/dL, respectively (starting at a BG of 120 mg/dL).13”

• cites [13] sourceNot checked — no full text of the source

• AssumptionThe authors state this as an assumption: For extrapolations, the starting BG concentration is 120 mg/dL, the starting BHB concentration is 0 mmol/L, and both analytes remain flat for 1 hour after suspension.

May combine two claims.

Following insulin suspension, if the baseline BG is 120 mg/dL, then BG can rise to level 1 hyperglycemia (181-250 mg/dL) within 2.2-3.8 hours and to level 2 hyperglycemia (>250 mg/dL) within 3.7-7.0 hours.

“As presented in Table 2, following insulin suspension, if the baseline BG is 120 mg/dL, then the BG can rise to level 1 and level 2 hyperglycemic concentrations, respectively, within 2.2-3.8 hours and 3.7-7.0hours.”

• AssumptionThe authors state this as an assumption: For extrapolations, the starting BG concentration is 120 mg/dL, the starting BHB concentration is 0 mmol/L, and both analytes remain flat for 1 hour after suspension.

May combine two claims.

No studies involving children were found, so the rate of increase of BG or BHB after insulin infusion interruption in children with T1D could not be estimated.

“As no studies involving children were found, we could not estimate the rate of increase of BG or BHB after insulin infusion interruption in children with T1D.”

May combine two claims.

Using the average rate of increase for BHB across studies, it would take 8.0 or 14.2 hours to reach a BHB level of 1.6 or 3.0 mmol/L, respectively, starting at a BHB of 0.0 mmol/L.

“For ketones, it would take 8.0 or 14.2 hours to reach a BHB of 1.6 or 3.0 mmol/L, respectively (starting at a BHB of 0.0 mmol/L).”

• AssumptionThe authors state this as an assumption: For extrapolations, the starting BG concentration is 120 mg/dL, the starting BHB concentration is 0 mmol/L, and both analytes remain flat for 1 hour after suspension.

Probably not a substantial claim: may not pass S3 (load-bearing).

Two authors independently reviewed all potentially relevant abstracts and determined whether to advance to full-text review.

“Two authors (C.N.H. and A.T.A.) independently reviewed all potentially relevant abstracts and determined whether to advance to full-text review.”

Probably not a substantial claim: may not pass S3 (load-bearing).

Disagreements in abstract review were resolved by a third author.

“Disagreements were resolved by a third author (M.A.K).”

May combine two claims.

An adult who experiences an occlusion at night could possibly develop severe hyperglycemia (BG 400 mg/dL) by the following morning or severe ketonemia (BHB 3.0 mmol/L) by the following day.

“This indicates that an adult who experiences an occlusion at night could possibly develop severe hyperglycemia (with BG 400 mg/ dL) by the following morning or severe ketonemia (with BHB 3.0 mmol/L) by the following day.”

May combine two claims.

Clinical studies and a simulation model similarly predicted that, following CSII interruption, moderate/severe hyperglycemia can occur within 5-9/6-14 hours, and clinical studies predicted that moderate/severe ketonemia can occur within 7-12/13-21 hours.

“Clinical studies and a simulation model similarly predicted that, following CSII interruption, moderate/severe hyperglycemia can occur within 5-9/6-14 hours, and clinical studies predicted that moderate/severe ketonemia can occur within 7-12/13-21 hours.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

The articles selected for extraction were limited to studies using insulin analogs (insulin lispro and insulin aspart), and faster-acting or slower-acting insulins might produce different results.

“The articles that we selected for extraction ended up being limited to studies using insulin analogs (insulin lispro and insulin aspart), and faster-acting or slower-acting insulins might produce different results.”

May combine two claims.

None of the clinical studies followed participants until they developed severe hyperglycemia or severe ketonemia, so the times to these metabolic abnormalities are the result of extrapolating average rates of increase.

“None of the clinical studies followed participants until they developed severe hyperglycemia or severe ketonemia, so our times to these metabolic abnormalities are the result of extrapolating average rates of increase.”